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Our resources and outputs, enabling
health and care research in the UK

Resource Exchange

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“Is it really a First in Human trial? Categorising and assessing the risks correctly”
Type: Blog
Author: MHRA
Keywords: MHRA, regulatory approvals, CTA, Clinical Trials, Clinical Trial Applications, Unblinding, IMP, GCP, SAEs, Safety reference information,
Link Reference: 723
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“Patients and the public are essential to reducing research waste”
Type: Blog
Author: Virginia Minogue and Bill Wells
Keywords: avir, adding value, embedding research, growing research, relevant research, patient and public involvement, PPI, research waste
Link Reference: 777
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#iamresearch
Type: Website resources
Author: NIHR
Keywords: benefits, research, awareness, impact
Link Reference: 225
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#whywedoresearch campaign
Type: Website resources
Author: Why we do research team
Keywords: Campaign, Awareness, Promoting, Embedding, Engagement, Communications, Twitter, Social Media
Additional Detail: Raising research awareness & opportunities for patients public and staff
Link Reference: 208
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10 tips for writing a lay summary
Type: Blog
Author: The Academy of Medical Sciences
Keywords: lay summary, research ethics, ethical research, protocol, grant writing, summaries, PPI, patient and public involvement, transparency
Link Reference: 2836
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100 reasons not to do research: changing cultures?
Type: Slide set
Author: Solent NHS Trust
Keywords: Culture, Improvement, Impact, Embedding, Leading
Link Reference: 213
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5 year Forward View 2014
Type: Policy
Author: NHS England
Keywords: Strategy, Policy, NHS, NHS England, Landscape, New Models of Care
Link Reference: 243
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9 and a Half Tweets
Type: Leaflet
Author: Salford R&D
Keywords: Twitter, Social Media, How to
Link Reference: 154
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A collaborative approach to develop clinical academic careers for scientists, nurses, allied health professionals and pharmacists
Type: Slide set
Author: Birmingham Health Partners
Keywords: Clinical Academic Careers, Capacity, Education, Training
Link Reference: 412
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A Guide for Clinical Audit, Research and Service Review — An educational toolkit designed to help staff differentiate between clinical audit, research and service review activities
Type: Guide
Author: HQIP
Keywords: QI, Quality Improvement, research, service evaluation, research definitions, research categories
Link Reference: 697
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A guide to reporting protocols of pilot & feasibility trials
Type: Guide
Author: Lehana Thabane and Gillian Lancaster
Keywords: reporting, transparency, protocols, feasibility trials, Clinical Trials, pilot trials
Link Reference: 760
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A joint statement setting out the legal and ethical requirements for seeking and documenting consent using electronic methods.
Type: Guidance
Author: HRA and MHRA
Keywords: consent, e-consent, electronic consent, clinical trials, GCP, e-systems, compliance, validated systems, e-signatures, ethics, research ethics
Link Reference: 754
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A new pathway for the regulation and governance of research (2011)
Type: Report
Author: Academy of Medical Sciences
Keywords: History, Governance, Regulation, Policy, Context
Link Reference: 246
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A New Research Delivery Team 18 Months On
Type: Slide set
Author: Calderdale and Huddersfield NHS Foundation Trust
Keywords: Teams, Management, Team Development, Staff, Management
Link Reference: 420
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A tool to help researchers create a publication list for grant applications
Type: Website resources
Author: Adrian Barnett@aidybarnett
Keywords: orchid, funding, grant applications, publications listing, outputs, dissemination, impact
Link Reference: 595
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Able to Improve
Type: 
Author: Health Foundation
Keywords: QI, Quality Improvement, research, service evaluation, research definitions, systems, embedding, impact, strategy
Link Reference: 2894
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About HRA Approval
Type: Website resources
Author: Health Research Authority
Keywords: HRA, HRA Approval, Research approval, Regulatory approval
Link Reference: 488
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About HRA approval:
Type: Leaflet
Author: HRA
Keywords: R&D Approval, Approval, HRA Approval, Research Governance,
Link Reference: 325
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Abstracts from the NIHR Involve Conference 2017
Type: Article
Author: Multiple Authors at NIHR INVOLVE Conference/ BMC Research Involvement & Engagement
Keywords: Patient Involvement, PPI, Engagement, Involvement, Patients and Public
Link Reference: 582
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Academy of Fab stuff
Type: Website resources
Author: Academy of Fab Stuff
Keywords: Improvement, Case Studies, NHS, QI,
Link Reference: 227
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Acceptability and design of video-based research on healthcare communication: Evidence and recommendations
Type: Guidance
Author: Ruth Parry and Marco Pino
Keywords: video-based research, healthcare communication research, ethical review, risks, acceptability, research design, good practice
Additional Detail: I could also provide a link to a two page summary version. Subject category could also be ethics as guidance attends to this in detail
Link Reference: 581
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AcoRD e-learning
Type: Slide set
Author: NIHR CRN
Keywords: AcoRD, Costing, Cost Attribution, Policy, Grants. elearning
Link Reference: 161
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Acord guidance for attributing costs
Type: Guidance
Author: Dept. Health
Keywords: AcoRD, Costing, Cost Attribution, Policy, Grants
Link Reference: 162
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AcoRD guidance part B FAQS – updated Dec 2018
Type: Guidance
Author: Dept. Health & Social Care
Keywords: AcoRD, costing, cost attribution, FAQs, SoECAT
Link Reference: 715
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Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs.
Type: Article
Author: Burnett, T., Mozgunov, P., Pallmann, P. et al.
Keywords: innovative trial designs, adaptive designs, platform trials, umbrella trials, research design
Link Reference: 3638
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Adding value in Research (AVIR) through research management, support, and leadership: Translating the NIHR AVIR framework & practical steps for R&D Depts., in health and care write up and summary of a multi-stakeholder workshop.
Type: Report
Author: NHS R&D Forum
Keywords: adding value, value, AVIR, waste, embedding research, growing research, relevant research, public health research, interventions,
Link Reference: 670
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Adding value, reducing research waste, the role of the NHS research and development management community.
Type: Article
Author: Virginia Minogue, (NHS England) and Bill Wells (Finance Department, Oxford Health NHS Foundation Trust)
Keywords: Adding value, research value, research waste, reducing research waste
Link Reference: 624
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Adults unable to consent for themselves
Type: Website resources
Author: HRA
Keywords: 
Link Reference: 273
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Adults with incapacity (Scotland) Act
Type: Website resources
Author: Scottish Government
Keywords: Consent, mental health, incapacity
Link Reference: 527
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Algorithm for defining a CTIMP
Type: Guidance
Author: MHRA
Keywords: MHRA, CTIMPS, Algorithm, Regulation
Link Reference: 437
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Allocation of programmed activities for research in NHS Trusts
Type: Guidance
Author: Association of UK University Hospitals (AUKUH)
Keywords: Research PAs, Programmed Activities, funding, allocation, research time, capacity
Link Reference: 187
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Alltrials
Type: Website resources
Author: Alltrials
Keywords: Trials, Registration, Transparency, Campaigns, Publication
Link Reference: 463
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Alternative Guide to understanding the NHS in England
Type: Guidance
Author: Kingsfund
Keywords: Guide, NHS, context, history, policy
Link Reference: 242
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Amendments
Type: 
Author: Health Research Authority
Keywords: Amendments, Sponsorship, Approval, SOP
Link Reference: 574
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AMRC directory of member charities
Type: Website resources
Author: AMRC list of charities
Keywords: Funding, Charities, Portfolio, AMRC, Grants
Link Reference: 355
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An Illustrated Guide to Quality Improvement
Type: Guide
Author: East London NHS Foundation Trust
Keywords: QI, Quality Improvement, research, service evaluation, research definitions, systems, embedding, impact
Link Reference: 758
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An Introduction to Data Integrity
Type: Training Course
Author: RQA Data Integrity Working Party
Keywords: Data Integrity
Additional Detail: eLearning Course
Link Reference: 2845
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Annual Report 2015/2016
Type: Example Report
Author: Leicestershire Partnership NHS Trust
Keywords: Board report, Impact, Annual Report, Performance
Link Reference: 52
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Annual Review
Type: Report
Author: Bristol, North Somerset and South Gloucestershire Clinical Commissioning Group Research & Evidence Team
Keywords: Research, evidence, evaluation, commissioning, knowledge mobilisation, BNSSG
Link Reference: 668
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Article: How to Manage ETCS
Type: Article
Author: Wessex Clinical Research Network
Keywords: ETCS, Costing, Costs, Funding, Excess Treatment Costs, grants, attribution, AcoRD
Link Reference: 167
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ASSESSMENT OF EXTERNAL SUB-CONTRACTORS/SERVICE PROVIDERS
Type: Example Tool
Author: VELINDRE NHS TRUST RESEARCH AND DEVELOPMENT
Keywords: Archiving, vendor assessment, vendor selection, data management, computer systems, laboratories, GCP, compliance, Sponsorship
Link Reference: 768
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Association for Health Care Communications & Marketing
Type: Website resources
Author: AHCCM
Keywords: Communications, Marketing, Social Media,
Link Reference: 146
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Association of Clinical Data Managers
Type: Website resources
Author: Association of Clinical Data Managers
Keywords: Data, Data Management, Network
Link Reference: 285
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Bath Non-NHS research approval policy
Type: Example Policy
Author: Bath R&D
Keywords: Research approval, UK research policy framework, research management, research governance, research permissions, approvals, policy, non-NHS, social care
Link Reference: 2846
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Being inclusive in Public Involvement (PI) in Health Research: Things to think about for researchers and practitioners
Type: Guide
Author: NIHR Involve
Keywords: PPI, involvement, power, relationships, inclusion, Public involvement, service users and carers, diversity
Link Reference: 747
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Benefitting from the Research Effect
Type: Report
Author: Royal College Physicians
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2831
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Best patient care, clinical research and you
Type: Slide set
Author: Dr William Van’t Hoft
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2824
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Best research for best health: a national health research strategy (2006)
Type: Policy
Author: Dept. Health
Keywords: Strategy, Policy, NHS Research, Dept. Health
Link Reference: 253
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BH/QMUL Sponsorship
Type: Example SOP
Author: Barts Health NHS Trust & Queen Mary University of London
Keywords: Sponsorship, Sponsor process, CTIMPS, ATMPS, nonCE, Medicinal Devices
Link Reference: 475
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Bioethics Briefing Note: Medical Implants:
Type: Paper
Author: Nuffield Council on Bioethics
Keywords: Ethics, Bioethics, access to treatments, experimental treatments, medical implants, governance, regulation, ethics
Link Reference: 773
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Bioethics briefing note: Patient access to experimental treatments
Type: Guide
Author: Nuffield Council on Bioethics
Keywords: Ethics, Bioethics, access to treatments, experimental treatments
Link Reference: 703
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Biomedical Research Centres
Type: Website resources
Author: NIHR
Keywords: Biomedical Research Centre, BRC, Centres, Research Units
Link Reference: 174
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BMJ blog: introducing unreported clinical trial of the week
Type: Blog
Author: BMJ
Keywords: Sponsorship, reporting, reproducibility, transparency, integrity, research integrity, clinical trials
Link Reference: 666
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BMJ Blog: Unreported Trial of the week. Use of Dexamethasone in pediatric asthma exacerbations (NCT02192827)
Type: 
Author: Nick DeVito and Ben Goldacre
Keywords: transparency, quality, integrity, study registrations, trials registration
Link Reference: 683
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BPS Guidance: The psychological needs of healthcare staff as a result of the Coronavirus pandemic
Type: Guidance
Author: The British Psychological Association
Keywords: Leadership, management, wellbeing, well-being, support, teams, workforce, COVID-19, COVID19,
Link Reference: 2859
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BRINGING QUALITY TO LIFE: Implementing A Quality Management System In Frontline NHS Research
Type: Slide set
Author: Guy’s and St. Thomas’ NHS Foundation Trust
Keywords: Quality, Quality Management Systems, QMS, SOPS, GCP, Sponsor QMS, Investigator Site QMS
Link Reference: 450
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Building a cross sector community
Type: Slide set
Author: Norfolk & Suffolk Primary & Community Care Research Office, James Paget University Hospitals Foundation Trust, Norfolk and Suffolk NHS Foundation Trust
Keywords: Partnerships, Community, Relationships, Cross-sector, Influencing, Leadership
Link Reference: 521
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Building Collaborations
Type: Website resources
Author: University of Washington & NIH
Keywords: Research, toolkit, partnerships, resources
Additional Detail: American site but some useful links
Link Reference: 520
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Can I have a word please? Communicating about R&D in the NHS
Type: Slide set
Author: University Hospitals Southampton NHS Foundation Trust
Keywords: Communications, marketing, engagement, promoting, social media, strategy, embedding
Link Reference: 212
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Cancer research involvement toolkit
Type: Website resources
Author: Cancer Research UK
Keywords: PPI, Patient and Public Involvement, toolkit
Link Reference: 261
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Case report form production for studies sponsored by the University of Leicester
Type: Example SOP
Author: University of Leicester, University of Loughborough & University Hospitals of Leicester NHS Trust Joint Research Office
Keywords: CRF, Case Report Form, Data, Design, SOP
Link Reference: 371
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Central Portfolio Management System (CPMS) User Guides
Type: Website resources
Author: NIHR- CRN
Keywords: Portfolio Management, NIHR CRN, CPMS, Research Management, Capacity & Capability, Central Portfolio Management System
Link Reference: 435
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Challenges for implementation science
Type: Paper
Author: NIHR
Keywords: Service evaluations, Innovation, Methods, Design, QI, Improvement
Link Reference: 232
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Checklist: WHO best practices in Clinical Trials Transparency
Type: Example checklist
Author: Transparimed
Keywords: transparency, quality, integrity, study registrations, trials registration
Link Reference: 682
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Chelsea & Westminster Research & Innovation strategy
Type: Example Strategy document
Author: Chelsea and Westminster Hospital NHS Foundation Trust
Keywords: Research, innovation, strategy, embedding, leadership
Link Reference: 510
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Chief Investigator Agreement for UCL Sponsored CTIMPS
Type: Example agreement
Author: University College London (UCL)
Keywords: Delegation responsibilities, Chief Investigator, Agreement, CI Agreement, Delegation matrix, Sponsorship, CTIMPS
Additional Detail: Also contains responsibilities matrix
Link Reference: 73
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Clinical Academic Career Pathways: A Trust Perspective
Type: Slide set
Author: Solent NHS Trust
Keywords: Capacity building, Capability, Clinical Academics, Growth, Leadership, Strategy
Link Reference: 411
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Clinical Research Nursing
Type: Website resources
Author: NIHR
Keywords: Research nursing, clinical research, research nurse, strategy, delivery teams
Link Reference: 578
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Clinical Research Safety Monitoring Policy
Type: Example Policy
Author: Portsmouth Hospitals NHS Trust
Keywords: SAEs, AEs, SUSARS, SARS, Adverse Events, Protocol, development, safety, safety monitoring, GCP,
Additional Detail: This policy includes information for safety monitoring in protocol development. Section 7, p12
Link Reference: 388
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Clinical Research Training
Type: Website resources
Author: NIHR CRN Learn
Keywords: NIHR CRN, GCP, Clinical research, training, pharmacy, informed consent, elearning
Link Reference: 204
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Clinical Risk Assessment
Type: Example Tool
Author: Portsmouth Hospitals NHS Trust
Keywords: Links to further risk categories not published here.
Additional Detail: For early assessment & Sponsor agreement to aide further protocol development
Link Reference: 470
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Clinical Study Data Request
Type: Website resources
Author: CDSR
Keywords: transparency, data sharing, data sharing platforms reproducibility, quality, integrity, responsible research, discoverability, clinical trials
Link Reference: 794
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Clinical Trial Assignment authorisation letter
Type: Guidance
Author: 
Keywords: transparency, quality, integrity, study registrations, trials registration, end of study reports, clinical study reports
Link Reference: 735
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Clinical Trial Assignment Request Form – guidance for completion
Type: Tool
Author: EMA
Keywords: Clinical trials, research transparency, EudraCT, Transparency, reporting, registration, regulatory compliance, CTIMPS, Sponsorship
Link Reference: 744
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Clinical Trial Reporting Manual for Universities and University Hospitals
Type: Guide
Author: QUEST
Keywords: End of study reporting, transparency, end of trial reporting, Sponsorship, registration, clinical trial reporting, quality, integrity, responsible research, discoverability, clinical trials
Link Reference: 2862
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Clinical Trials .Gov
Type: Website resources
Author: NIH
Keywords: Registration, Registry, Transparency, Disclosure,
Link Reference: 465
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Clinical Trials Toolkit
Type: Website resources
Author: NIHR
Keywords: Clinical Trials, CTIMPS, SOPs, Guidance, Good Practice, MHRA, Compliance, Quality, GCP
Link Reference: 320
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Clinical trials: How the UK is researching medicines of the future
Type: Report
Author: Association of British Pharmaceutical Industries
Keywords: Clinical trials, strategic context, future, horizon, embedding
Link Reference: 2832
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Clinical Trials.Gov: Checklist for Sponsors of clinical trials that may fall under US legal reporting requirements under ‪FDAAA law
Type: Tool
Author: Clinical Trials.Gov
Keywords: Sponsorship, sponsors, transparency, quality, integrity, study registrations, trials registration, FDAA
Link Reference: 707
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Close out flow chart for sponsored studies
Type: Example Flowchart
Author: Portsmouth Hospitals NHS Trust
Keywords: Process Map, End of Study, Close Out
Link Reference: 269
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Cochrane Database of Systematic Reviews
Type: Website resources
Author: Cochrane Collaboration
Keywords: Systematic reviews, reviews, literature, evidence, development, protocol
Link Reference: 376
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Cochrane Interactive Learning: Conducting an Intervention Review
Type: Training Course
Author: Cochrane collaboration
Keywords: e-learning, training, systematic reviews, interactive learning, design, research design, cochrane, self directed learning
Additional Detail: Some free modules.
Link Reference: 593
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Code of Conduct For Clinical Research Monitors and Auditors – Remote Access
Type: Example Tool
Author: Royal Free London NHS Foundation Trust
Keywords: Monitoring, audit, code, remote access, COVID-19, COVID
Link Reference: 3629
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Code of Connection
Type: Example agreement
Author: Guy’s & St Thomas’ NHS Foundation Trust
Keywords: COVID-19, COVID19, COVID, advice, agreement, EHR, access, Information governance, PID, Confidentiality, guidance, researchers, pandemic, emergency, urgent, remote monitoring
Link Reference: 2879
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Comments from the Department of Health on reports on the use of Research Capability Funding in 2015/16
Type: Report
Author: Department of Health
Keywords: RCF, Funding, Capability
Link Reference: 416
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Commercial research income distribution policy
Type: Example Policy
Author: Portsmouth Hospitals NHS Trust
Keywords: Finance, distribution, commercial policy, income, industry
Link Reference: 406
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Commercial research policy
Type: Example Policy
Author: North Bristol NHS Trust
Keywords: Commercial, income, distribution, set up. capacity, capability, industry, contract research
Link Reference: 407
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Common issues identified during Clinical trial applications: Clinical
Type: Guidance
Author: MHRA
Keywords: MHRA, regulatory approvals, CTA, Clinical Trials, Clinical Trial Applications, Unblinding, IMP, GCP, SAEs, Safety reference information,
Link Reference: 659
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Communicating research
Type: Slide set
Author: Central Manchester University Hospitals NHS Foundation Trust
Keywords: Communications, marketing, engagement, promoting, social media, strategy, embedding
Link Reference: 141
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Communications in Health Care Improvement – a toolkit
Type: Website resources
Author: Health Foundation
Keywords: Communications, marketing, engagement, promoting, social media, strategy, embedding, improvement, QI
Additional Detail: This toolkit is designed for improvement and not explicitly for research but is useful for all
Link Reference: 142
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Communications plan template
Type: Example Plan
Author: Join Demential Research
Keywords: Communications, marketing, engagement, promoting, social media, strategy, embedding disseminating
Link Reference: 143
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Communications Strategy
Type: Example Strategy
Author: Health & Care Research Wales
Keywords: Communications, marketing, engagement, promoting, social media, strategy, embedding
Link Reference: 144
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Competency Framework for Trial Managers
Type: Tool
Author: UK Trial Managers Network
Keywords: competency framework, clinical research, research, knowledge, skills, trial management, tasks
Link Reference: 2864
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Computer Systems Validation – GCP
Type: Blog
Author: MHRA
Keywords: Computer systems validation, GCP, CTIMPS, MHRA
Link Reference: 436
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Concordat on open research data
Type: Website resources
Author: Research Councils UK
Keywords: Data sharing, transparency, dissemination, data management, open access,
Additional Detail: Links to http://www.re3data.org/ open data platforms on p22
Link Reference: 444
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Conducting a systematice review. What you can do
Type: Website resources
Author: Cochrane Collaboration
Keywords: Systematic reviews, Literature, Developing, Cochrane
Link Reference: 375
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Confirmation of capacity and capability
Type: Example SOP
Author: York Foundation Trust
Keywords: SOP, Capacity, Capability, Confirmation, Assess, Arrange, HRA approval, Study set up
Link Reference: 367
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Consensus statement on public involvement and engagement with data intensive health research
Type: Article
Author: International Journal of Population Data Science
Keywords: PPI, leading research, embedding research, co-production, service users and carers, data, data intensive health research
Link Reference: 738
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Consent and Participant Information Sheet Preparation Guidance
Type: Guidance
Author: Health Research Authority
Keywords: Consent, PIS, Information, Guidance, Study development, Patient information, Study documentation, Set up
Link Reference: 271
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Considerations and recommendations for conducting qualitative research interviews with palliative and end-of-life care patients in the home setting: a consensus paper
Type: Article
Author: BMJ: Supportive & Palliative Care – Marie Curie Palliative Care Research Centre, Cardiff University
Keywords: qualitative research, ethics, end of life, home setting, research conduct, ethical conduct, interviews, research practice, palliative care, consensus
Link Reference: 736
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Coronavirus questions answered
Type: Website resources
Author: ABPI
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, questions, Vaccines, technology, research, medicines development
Link Reference: 2865
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Corporate induction – guide to signposting patients into clinical trials in the NHS
Type: Example Leaflet
Author: Rachael Dowling
Keywords: corporate induction, embedding research, NHS staff, guidance
Additional Detail: Corporate induction – guide to signposting patients into clinical trials in the NHS
Link Reference: 776
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COS-STAP (Core Outcome Set-STAndardised Protocol Items)
Type: Guideline
Author: Jamie J. Kirkham, Sarah Gorst, Douglas G. Altman, Jane M. Blazeby, Mike Clarke, Sean Tunis, Paula R. Williamson1* and for the COS-STAP Group
Keywords: protocol standards, core outcome set, protocols, PPI, Sponsorship, study development, design, Sponsor
Link Reference: 745
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Count Me In. Making participation in research accessible to all
Type: Slide set
Author: Solent NHS Trust
Keywords: Opt-in, access to research, opportunity, embedding, patient contact, consent to contact
Link Reference: 211
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COVID-19 briefing to all staff involved in delivering research 13/02/2020
Type: Example Guidance
Author: Durham Tees Valley Research Alliance
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent
Additional Detail: Please note the date of publication and that all may be updated over time
Link Reference: 2855
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COVID-19 National Policy, Regulation & Guidance
Type: Guidance
Author: Joint Research Management Office, Queen Mary University of London and Barts Health NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent
Link Reference: 2851
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COVID-19 Research & Platform (Complex Innovative Design) Trials Infographic
Type: Infographic
Author: NIHR CRN
Keywords: CIDS, novel methods, innovative trial design, platform studies, RCTS, COVID-19, COVID19, adaptive trial designs
Link Reference: 2860
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COVID-19 Resources from Trial Forge
Type: Website resources
Author: Trial Forge
Keywords: Sponsorship, set up, process, Sponsors, Trial management, Trials, Evidence, COVID-19, COVID19, recruitment, retention, consent
Link Reference: 2858
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COVID-19: Deviations to Current SOPs
Type: Example SOP
Author: Newcastle Joint Research Office
Keywords: SOPS, GCP, Deviations, COVID19, COVID-19, Quality Management
Link Reference: 2857
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COVID-19: Deviations to Current SOPs V2
Type: Example SOP
Author: Newcastle Joint Research Office
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, SOPS, deviations
Additional Detail: Please note the date of publication and that all may be updated over time
Link Reference: 2874
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COVID-19: Guidance for Investigators
Type: 
Author: Kings Health Partners Clinical Trials Office
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent
Link Reference: 2853
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CQC inspection – Trust experience and overview
Type: Example
Author: Royal National Orthopaedic Hospital NHS Trust – Iva Hauptmannova Head of R&D
Keywords: CQC, inspection, well-led, embedding research, regulatory, leading research, Care quality commission
Link Reference: 729
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CQC Inspection and Well-Led Research in NHS Trusts.
Type: Report
Author: NIHR CRN CC
Keywords: Well led, CQC, inspection, embedding, research markers
Link Reference: 750
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CQC Well Led Inspection Framework
Type: 
Author: CQC
Keywords: well led, organisational leadership, quality organisations, research active organisations, CQC, inspection,
Link Reference: 721
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Creating a Culture of Curiosity: Top Tips to embed Research and Innovation (2015)
Type: Slide set
Author: Walton Centre NHS Foundation Trust
Keywords: Innovation, Embedding, Research culture, Leadership, Strategy, Engagement, Toolkit
Additional Detail: Links to an innovation toolkit https://nhsinnovationtoolkit.wordpress.com/
Link Reference: 209
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CRF network
Type: Website resources
Author: CSO & NIHR
Keywords: CRF, Clinical Research Facility, Network, UK CRF Network
Link Reference: 176
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Critical appraisal skills programme (CASP)
Type: Website resources
Author: Critical Appraisals Skills Programme (CASP)
Keywords: CASP, evidence, literature, appraisal, training
Link Reference: 196
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CRN Metabolomics e-learning course
Type: Training Course
Author: NIHR CRN
Keywords: e-learning, training, clinical teams, research delivery, metabolomics, phenotyping, metabolic profiling studies, analytical platforms and biomarker identification.
Additional Detail: For clinical staff and trials teams, clinical research nurses and other clinicians
Link Reference: 625
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CTIMP Trial Master File Contents
Type: Example Form
Author: University Hospital Bristol NHS Foundation Trust
Keywords: TMF, GCP, Essential documents, Archiving, Close-out, Monitoring, Trial Master File, Filing Structure, Checklist, Audit
Additional Detail: Can be adapted for other study types
Link Reference: 296
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CTIMPS: Submitting for a Clinical Trial Authorisation
Type: Guidance
Author: MHRA
Keywords: CTA, CTIMP, Clinical Trial Authorisation, Approval, MHRA, GCP. Regulation, Compliance
Link Reference: 338
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CTU/Sponsors Task Allocation Matrix (UoS Branded)
Type: Example Tool
Author: University of Southampton, CTU
Keywords: Sponsorship, set up, process, Sponsors, sponsor process, delegation of responsibilities, delegation of duties, roles, agreements, oversight
Link Reference: 704
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CTU/Sponsors Task Allocation Matrix (UoS UnBranded for re-use)
Type: Example Tool
Author: University of Southampton, CTU
Keywords: Sponsorship, set up, process, Sponsors, sponsor process, delegation of responsibilities, delegation of duties, roles, agreements, oversight
Link Reference: 705
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Cumbria and North East Primary Care Research Strategy
Type: Example Strategy
Author: NHS North of England Commissioning Support Unit (NECS), and National Institute for Health Research Clinical Research Network North East and North Cumbria (NIHR CRN NENC)
Keywords: strategy, primary care, partnerships, system wide leadership, systems
Link Reference: 728
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Data & Tissue Toolkit
Type: Website resources
Author: Medical Research Council in collaboration with partners
Keywords: Data, information governance, tissue, personal information, data protection, samples, governance, regulation, compliance
Additional Detail: A comprehensive e-tool
Link Reference: 334
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Data and Tissues Toolkit
Type: Website resources
Author: Medical Research Council
Keywords: Data, information governance, tissue, personal information, data protection, samples, governance, regulation, compliance
Additional Detail: Link is part of a toolkit
Link Reference: 460
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Data Governance in the new Era
Type: Slide set
Author: NHS Digital
Keywords: Data, information governance, personal information, data protection, Caldicott, governance, regulation, compliance
Link Reference: 331
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Data Management Plan templates
Type: Example Form
Author: Barts Health NHS Trust & Queen Mary University of London
Keywords: Data, Data Management, Data Management Plan, Analysis, CTIMPS, GCP, Compliance
Link Reference: 277
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Data Management Plan templates
Type: Example Form
Author: Leeds Teaching Hospitals NHS Foundation Trust
Keywords: Data, Data Management, Data Management Plan, Analysis, CTIMPS, GCP, Compliance
Link Reference: 279
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Data Management Plan templates
Type: Example Form
Author: University Hospitals Bristol NHS Foundation Trust
Keywords: Data, Data Management, Data Management Plan, Analysis, CTIMPS, GCP, Compliance
Additional Detail: Can be adapted for other study types
Link Reference: 281
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Data Management Plan templates
Type: Example Form
Author: Medical Research Council
Keywords: Data, Data Management, Data Management Plan, Analysis, Data integrity
Link Reference: 284
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Data platforms to support research evaluation & practice
Type: Slide set
Author: Swansea University
Keywords: Data sharing, e-research, data platform, informatics, data banks
Link Reference: 192
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Data protection and research data
Type: Guidance
Author: JISC
Keywords: Data, Data Controllers, Data Subjects, legal, ICO
Link Reference: 336
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Data protection changes in 2018: what does that mean for research?
Type: Guidance
Author: Health Research Authority & Devolved Administrations
Keywords: GDPR, data protection, information governance, data protection legislation, data protection act, general data protection regulation
Link Reference: 588
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Data Saves Lives Animation
Type: Video
Author: Understanding Patient Data
Keywords: patient data, data saves lives, data for research, animations for patients
Additional Detail: Animations
Link Reference: 610
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Data sharing in clinical trials – practical guidance on anonymising trial datasets
Type: Article
Author: 
Keywords: data sharing, anonymisation, data sets. clinical trials data, data management
Additional Detail: Useful for Sponsors, CTUS and research teams when anonymising data sets for future use.
Link Reference: 594
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Database Change Control Form
Type: Example Form
Author: Barts Health NHS Trust & Queen Mary University of London
Keywords: change control, version control, data management, database, data integrity,
Link Reference: 276
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Database lock and closedown form
Type: Example Form
Author: Papworth Hospital NHS Foundation Trust
Keywords: Close Out, Database Lock, Lock, End of Study, Form,
Link Reference: 280
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Database requirements and specifications form
Type: Example Form
Author: Barts Health NHS Trust & Queen Mary University of London
Keywords: Data, Data Management, Data Management Plan, Database Build, Oversight
Link Reference: 278
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Decision guide: University and business collaboration agreements (Lambert Toolkit)
Type: Website resources
Author: IP Office
Keywords: Collaboration agreements, university, partnerships, contracts
Additional Detail: To support collaboration agreements. Aimed at Universities but relevant to all
Link Reference: 160
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Defining Research
Type: Leaflet
Author: Health Research Authority
Keywords: Research, audit, service evaluation, quality improvement, public health surveillance
Link Reference: 373
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Defining research category as Sponsor
Type: Example SOP
Author: University Hospitals Leicester NHS Trust
Keywords: SOP, Sponsor, Joint Research Office
Link Reference: 439
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Delegation of roles & responsibilities for Trust Sponsored CTIMPS
Type: Example SOP
Author: Cambridge University Hospitals NHS Foundation Trust
Keywords: Standard Operating Procedure; SOP; Delegation Log
Link Reference: 286
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Deming, data and observational studies A process out of control and needing fixing
Type: Article
Author: S. Stanley Young Alan Karr
Keywords: study design, research methods, observational studies, data
Link Reference: 774
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Designing & developing a Case Report Form
Type: Website resources
Author: The Kings Health Partners Clinical Trials Office
Keywords: CRF design, data collection, study design, study set up
Link Reference: 370
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Developing a patient registry a practical guide
Type: Guide
Author: Medical Research Charities Group Ireland
Keywords: Patient data, registries, patient registries, databases,
Link Reference: 725
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Developing a Research Strategy
Type: Example Strategy document
Author: East & North Hertfordshire NHS Trust
Keywords: Strategy
Link Reference: 513
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Developing a Research Strategy
Type: Blog
Author: East & North Hertfordshire NHS Trust
Keywords: Blog; Strategy; Planning;
Link Reference: 515
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Developing a Research Strategy
Type: Example Strategy document
Author: Royal College of Physicians
Keywords: Academic Research, Medical Research, Case Studies, Strategy, Research Culture, Collaboration
Link Reference: 518
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Developing our Clinical Research Nursing Strategy 2017-2020
Type: Report
Author: NIHR
Keywords: Research nursing, clinical research, research nurse, strategy, delivery
Link Reference: 577
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Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
Type: Article
Author: Katie Gillies and Marion K. Campbell
Keywords: clinical trials, decision making, consent, decision aids
Link Reference: 755
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Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study
Type: Article
Author: Site Performance Metrics for Multicentre Randomised Trials Collaboration
Keywords: Site performance, metrics, KPIs, multicentre trials, RCTS, standard metrics, performance
Link Reference: 710
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Development of the Keele CTU Quality Management System
Type: Slide set
Author: Keele University CTU
Keywords: Quality Management, QA, Responsibilities, Development, quality assurance; powerpoint; slide; presentation
Link Reference: 451
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Development Safety Update Report (DSUR) Form
Type: Example Form
Author: York Foundation Trust
Keywords: Safety, reporting, transparency; adverse event,
Link Reference: 304
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Documas
Type: Website resources
Author: Documas
Keywords: LPMS, CPMS, research management system, Documas
Link Reference: 431
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Draft ethics guidelines for trust worthy AI
Type: Guide
Author: European Commission
Keywords: Ethics, ethical research, AI
Additional Detail: Draft for consultation
Link Reference: 727
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Dragons Den Scheme
Type: Article
Author: South TeesHospitals NHS Foundation Trust
Keywords: pump-priming, innovation, feasibility studies, grant
Link Reference: 185
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DTVRA LOCAL RESTART PROFORMA FOR RESEARCH TRIALS PAUSED DUE TO COVID-19
Type: Example Form
Author: Durham Tees Valley Research Alliance
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, restart, reset
Additional Detail: Please note the date of publication and that all may be updated over time
Link Reference: 2875
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Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review.
Type: Paper
Author: Cragg WJ, Hurley C, Yorke-Edwards V, Stenning SP. Clinical Trials. February 2021.
Keywords: Monitoring, audit, code, remote access, COVID-19, COVID, Sponsorship, Sponsors
Link Reference: 10657
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E-consent resources
Type: Website resources
Author: Transcelerate
Keywords: e-consent, consent, digital, electronic, GCP
Additional Detail: Lots of resources for managing e-consent
Link Reference: 214
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e-source readiness assessment 2021
Type: Website resources
Author: eClinical Forum
Keywords: EHR, clinical systems, validation, sites, sponsors, data, source data, CTIMPs, GCP, confidentiality, regulated research
Link Reference: 13636
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Early career Dementia researchers network, toolkit & resources for dementia research and researchers.
Type: Toolkit
Author: NIHR
Keywords: Research training, incapacity, consent, toolkit, dementia research
Link Reference: 614
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Early Phase Bed space Checklist
Type: Example Tool
Author: UKCRF Network Research Nurses and Practitioners Group
Keywords: CRF, bedspace, early phase trials, IMP, CTIMPS, GCP
Additional Detail: Available to download from the UKCRF Portal
Link Reference: 3631
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eData research & innovation service
Type: Slide set
Author: National Services Scotland
Keywords: data, systems, infrastructure
Link Reference: 193
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EDGE
Type: Website resources
Author: Edge Clinical
Keywords: research management system; systems, data
Link Reference: 432
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Electronic Health Records
Type: Blog
Author: Jennifer Martin MHRA
Keywords: Sponsor, site. EHR, GCP, Compliance, audit trails, access & security, GDPR
Link Reference: 775
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EMA good clinical practice new Q&A 10 & 11, added Dec 18
Type: Guidance
Author: European Medicines Agency
Keywords: ICH GCP, GCP, good clinical practice, home care nurses, home care, delegation of duties, written agreements. third party vendors. vendors, CTIMPS, Sponsorship
Link Reference: 778
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Embedded research resources
Type: Website resources
Author: Embedded research project
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 791
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Embedding research in an NHS Trust
Type: Slide set
Author: NIHR CRN CC
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Additional Detail: A guide for CRN staff supporting NHS Trusts to embed research
Link Reference: 790
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Embedding Research Strategy & Culture Symposium Slide set 2018
Type: Slide set
Author: Variety of speakers for the NHS R&D Forum Embedding symposium 2018
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, well led, CQC., PPI
Link Reference: 759
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Embedding Research Symposia 2019
Type: Slide set
Author: NHS R&D Forum
Keywords: embedding, symposia
Link Reference: 789
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Embedding Research to Improve Patient Care
Type: Slide set
Author: Keith Wilson, Patient Research Ambassador
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2825
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End of the EU Exit Transition Period: Quick Facts for Research: v1.0 Newcastle JRO (Jan 2021)
Type: Guide
Author: Newcastle JRO
Keywords: Brexit, EU transition, research regulations, devices, IMP, data, PIP, human tissue
Additional Detail: Please be mindful that guidance may need to be updated. This version 1.0 was published in January 2021
Link Reference: 7651
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End of Trial Procedures
Type: Example SOP
Author: Cambridge University Hospitals Teaching Foundation Trust
Keywords: SOP; process, end, study
Link Reference: 315
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Engaging NHS Staff in Research
Type: Article
Author: Jill Maben, professor of health services research and nursing, Angela King, patient advocate and carer
Keywords: NHS staff, embedding research, NHS engagement, citizen science, PPI,
Link Reference: 764
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ENHT COVID19 Research Update 02 dated 17th March 2020
Type: Example Guidance
Author: East and North Herts NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent
Link Reference: 2850
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ENRIO – European Network of Research Integrity Offices
Type: Website resources
Author: European office of research integrity
Keywords: research; quality, integrity, standards
Link Reference: 345
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Ensuring that COVID-19 Research is Inclusive: Guidance from the NIHR CRN INCLUDE project ( GENERAL)
Type: Guidance
Author: NIHR CRN
Keywords: embedding research, research set up, inclusion, include, unrepresented groups, PPI, diversity, equality
Link Reference: 2895
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Ensuring that COVID-19 Research is Inclusive: Guidance from the NIHR CRN INCLUDE project (SPECIFIC)
Type: Example Guidance
Author: NIHR CRN
Keywords: embedding research, research set up, inclusion, include, unrepresented groups, PPI, diversity, equality
Link Reference: 2896
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Ensuring that COVID-19 Research is Inclusive: Guidance from the NIHR CRN INCLUDE project (SUMMARY)
Type: Guidance
Author: NIHR CRN
Keywords: embedding research, research set up, inclusion, include, unrepresented groups, PPI, diversity, equality
Link Reference: 2897
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Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality
Type: Article
Author: Kelly et al; Trials volume 20, Article number: 416 (2019
Keywords: trial leadership, trial management, trials, co-applicancy, project management, monitoring, sponsorship, SAP, delegation of duties
Link Reference: 780
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eSRA (eSource-Readiness Assessment)
Type: Website resources
Author: eClinical Forum/ eclinical Network
Keywords: Electronic Health Record, EHR, EMR, Source Data, GCP, Compliance
Additional Detail: Please be aware that you need to register to access the information on this site however registration is free. If you register as an investigator site then the materials will become available free of charge.
Link Reference: 318
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eSRA 2020: A free assessment tool for sites to assess if their EHR System is suitable for sourcing clinical research data
Type: Toolkit
Author: eClinical Forum
Keywords: EHR, source records, source data, compliance, GCP, Clinical Trials, CTIMPS
Additional Detail: The eClinical Forum, a non-commercial, non-profit global organization with over 45 organizations active in clinical research, has established criteria to allow compliant use of EHR data in clinical trials. Their eSource Readiness Assessment (eSRA) checklist has been created with sponsors and research sites to simplify the self-assessment of EHR system use in clinical research. It is a standardized approach and free of charge. It allows sites to reuse their assessment across all their clinical trial sponsors. It provides all users (clinical research sponsors, CROs, sites, regulators, technology vendors) with the ease of a common assessment that is solely based on regulatory guidance. eSRA has already been used in several thousand sites worldwide since 2016. The 2020 version has been updated based on regulatory guidance issued during 2019
Link Reference: 2854
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Essential documents & templates
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: templates; examples, study, master, file, trial
Link Reference: 294
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Essential Documents for the Conduct of a Clinical Trial
Type: Example Infographic
Author: Sally Humphreys, West Suffolk NHS Foundation Trust
Keywords: Essential documents, GCP, clinical trials,
Link Reference: 297
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ETC Issue Collection Template
Type: Tool
Author: NHSE/DH
Keywords: ETC, Acord, costs, funding
Link Reference: 165
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Ethical issues of health research involving children and young people
Type: Website resources
Author: Jenny Preston,
Keywords: Consent, PPI, paediatric research, children and young people, assent, dissent, research design, research ethics, ethical research,
Additional Detail: Includes a blog, articles, infographics and a podcast
Link Reference: 765
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eTMF Vendor Selection Template, published March 2017
Type: Example Tool
Author: Health Sciences Records & Archives Association
Keywords: Vendor assessment, vendor selection, eTMF, compliance, GCP, Sponsorship, set up, TMF
Link Reference: 767
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EudraCT – European Clinical Trials Database
Type: Website resources
Author: EMA
Keywords: database; reporting; public;
Link Reference: 466
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EudraCT & EU CTR Frequently asked questions
Type: Guidance
Author: European Medicines Agency
Keywords: Transparency. Trial registration, trial reporting, CTIMPS, clinical trial regulations
Link Reference: 3651
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Evaluation of digital health products
Type: Toolkit
Author: Public Health England
Keywords: Evaluation, digital health products, Apps, AI, Sponsorship, study design, set up, approvals, research governance, systems, health services research
Link Reference: 2847
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Evaluation Works: a toolkit to support the commissioning of health and care services
Type: Website resources
Author: NHS England, Avon Primary Care Research Collaborative & West of England AHSN
Keywords: commission, NHS, services, CCG, funding
Link Reference: 374
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Evaluation: what to consider: Commonly asked questions about how to approach evaluation of quality improvement in health care
Type: Guidance
Author: Health Foundation
Keywords: NHS, commissioning
Link Reference: 230
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Everyone Included Improving Access to Research
Type: Slide set
Author: Avon & Wiltshire Mental Health Partnership NHS Trust
Keywords: 
Additional Detail: included, access, mental, improving, Durant, McCann,
Link Reference: 210
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Example of Development Safety Update Report (DUSR) – completed
Type: Example Report
Author: ICH
Keywords: Safety, reporting, adverse, event,
Link Reference: 303
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Example research & innovation newsletter – Leeds NHS
Type: Example Newsletter
Author: Leeds and York partnership NHS Foundation Trust
Keywords: research, newsletter, promotion
Link Reference: 224
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Example SOPS
Type: Example SOP
Author: University Hospitals Leicester NHS Trust
Keywords: SOP, quaility, checklist, process
Link Reference: 452
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Example SOPS
Type: Example SOP
Author: Newcastle Joint Research Office
Keywords: SOP, process,
Link Reference: 453
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Example SOPS
Type: Example SOP
Author: York Foundation Trust
Keywords: SOP, process
Link Reference: 456
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Experiences of nurses, midwives & allied health professionals in research,
Type: Video
Author: Health Talk
Keywords: Research nurse, nursing, midwife, midwifery, AHP, professions in research, teams, operations, research delivery
Link Reference: 752
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Explaining the stages of Clinical Trials
Type: Example Infographic
Author: University Hospitals Southampton NHS Foundation Trust
Keywords: phase, trial, picture
Link Reference: 222
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External Monitoring Research Visits: Code of Conduct
Type: Example
Author: Cambridge University Hospitals NHS Trust/ Cambridge BRC
Keywords: Monitoring, COVID-19, external visitors, monitors, code of conduct
Link Reference: 2887
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FAIR Sharing: Standards, Databases, Policies
Type: Website resources
Author: FAIR Sharing
Keywords: transparency, data sharing, data sharing platforms reproducibility, quality, integrity, responsible research,
Link Reference: 797
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Farr instititute of health informatics research
Type: Website resources
Author: Farr Institute
Keywords: informatics statistics research ethics
Link Reference: 194
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Faster easier clinical research
Type: Policy
Author: NIHR
Keywords: clinical trials faster metrics framework
Link Reference: 256
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Financial Procedures for research studies
Type: Example SOP
Author: Papworth Hospital NHS Foundation Trust
Keywords: Procedure clinical trial studies finance expenditure
Link Reference: 405
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Finding clinical trials, research registers and research results
Type: Website resources
Author: University of York
Keywords: reference search clinical trials database funding
Link Reference: 381
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Finding research funding opportunities
Type: Website resources
Author: Royal college of Nursing
Keywords: Research funding nursing application grant scholarship
Link Reference: 362
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Flow Chart: How Excess Treatment Costs will be covered for existing studies* in England after 1 October 2018
Type: Guidance
Author: NIHR CRN
Keywords: ETCs, Excess Treatment Costs, Funding research, AcoRD, costings, finance, financial management,
Link Reference: 686
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Forum Courses
Type: Website resources
Author: NHS R&D Forum
Keywords: courses healthcare research development forum
Link Reference: 203
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Frameworks for supporting patient and public involvement in research: systematic review and co-design pilot.
Type: Paper
Author: Prof Trisha Greenhalgh
Keywords: PPI, leading research, embedding research, co-production, service users and carers
Link Reference: 757
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Funding Database
Type: Website resources
Author: Plymouth Hospitals NHS Trust
Keywords: research trials funding database
Link Reference: 357
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Gaining Sponsorship & supporting Sponsor oversight
Type: Example SOP
Author: University hospitals Bristol NHS Foundation Trust
Keywords: research sponsor sponsorship procedure
Link Reference: 483
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GCP compliance in relation to TMFS for management audit and inspection of clinical trials
Type: Paper
Author: EMA
Keywords: Trial Master File TMF eTMF essential documents GCP inspection archiving scanning retention destruction
Link Reference: 293
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GCP Forum
Type: Website resources
Author: MHRA
Keywords: forum archive good clinical practice MHRA regulatory
Link Reference: 319
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GCP Guide
Type: Guidance
Author: MHRA
Keywords: GCP good clinical practice guide eBook legislation guidance
Additional Detail: Requires purchase
Link Reference: 323
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GCP Regulations & Guidelines
Type: Website resources
Author: Research Quality Association
Keywords: RQA MHRA quality guidelines legislation regulations
Link Reference: 322
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GCP Serious Breaches – 2018 edition
Type: Blog
Author: MHRA
Keywords: GCP, safety, serious breaches, breaches, quality, data, reporting, inspection, regulatory ready
Link Reference: 751
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GDPR – What researchers need to know
Type: Blog
Author: MRC Regulatory Support Centre
Keywords: GDPR, data protection, information governance, data protection legislation, data protection act, general data protection regulation
Link Reference: 627
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GDPR Key Facts for Research
Type: Guide
Author: MRC Regulatory Support Unit & HRA
Keywords: GDPR, data protection, information governance, data protection legislation, data protection act, general data protection regulation
Additional Detail: The NHS R&D Forum has had input into this resource
Link Reference: 643
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GDPR Learning Resources
Type: Website resources
Author: MRC Regulatory Support centre
Keywords: GDPR, training, confidentiality
Link Reference: 671
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GDPR operational guidance
Type: Guidance
Author: Health Research Authority
Keywords: GDPR, Data protection, General Data Protection Regulation, Guidance
Link Reference: 602
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GDPR operational guidance and templates for use
Type: Guidance
Author: Health Research Authority
Keywords: GDPR, information governance, data protection, data regulation, consent, lawful basis, safeguard,s transparency, UK legislation, templates
Additional Detail: The HRA website contains the most up to date information and will be updated over time
Link Reference: 642
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General Data Protection Regulation – FAQS
Type: Website resources
Author: MRC Regulatory Support Centre
Keywords: GDPR, data protection, information governance, data protection legislation, data protection act, general data protection regulation
Link Reference: 650
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General Data Protection Regulation (GDPR) – Preparations for implementation (August 2017)
Type: Guidance
Author: Medical Research Council
Keywords: GDPR, Data protection, General Data Protection Regulation, Guidance
Additional Detail: This will be updated overtime
Link Reference: 125
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Global Clinical Data Sharing Platform
Type: Website resources
Author: Vivli
Keywords: transparency, data sharing, data sharing platforms reproducibility, quality, integrity, responsible research,
Link Reference: 693
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Going the extra mile: improving the nations health and wellbeing through public involvement in research
Type: Policy
Author: NIHR
Keywords: NIHR policy involvment public involve
Link Reference: 250
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Going the Extra Mile: Improving the nations health and wellbeing through public involvement in research
Type: Report
Author: Review team led by Simon Denegri. Commissioned by the Director General Research and Development/Chief Medical Officer
Keywords: PPI. Patient and public involvement, Patient involvement,
Link Reference: 529
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Good Clinical Practice: A Guide to Archiving
Type: Guide
Author: Health Sciences Records & Archives Association
Keywords: Archiving, TMF, Essential documents
Link Reference: 770
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Good Clinical Practice: Inspection Prep and Conduct Guidance for Clinical Trials Units
Type: Guidance
Author: UKCRC Registered Clinical Trials Units
Keywords: GCP, CTU, Clinical Trials Unit, Clinical Trials GCP training, Research operations, staff, training, CTIMPS, Sponsor, Host
Link Reference: 731
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Good practice principles when assessing, arranging and confirming local capacity and capability for CRN supported studies
Type: Guidance
Author: NIHR Clinical Research Network
Keywords: Capacity, Capability, Assess, Arrange, Confirm, Confirmation, Study Set Up, Approvals
Link Reference: 365
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Greater Manchesters Route Map for Initiating Clinical Trials
Type: Website resources
Author: Manchester Academic Health Sciences Centre
Keywords: trial, planning, initiation, support
Link Reference: 363
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Growing pains (or growth and leadership in public engagement with research)
Type: Blog
Author: Bella Starling
Keywords: PPI, leading research, embedding research, co-production, service users and carers
Link Reference: 701
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Guidance for CTUs undertaking Covid19 contingency planning
Type: Guidance
Author: UKCRC Registered Clinical Trials Units
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, Contingency planning
Additional Detail: Please note the date of publication and that all may be updated over time
Link Reference: 2856
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Guidance for managing authorisations
Type: Guide
Author: MHRA
Keywords: MHRA ammendments protocol clinical trial changes
Link Reference: 268
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Guidance for researchers on PPI feedback
Type: Guidance
Author: NIHR CLAHRC- East of England
Keywords: PPI, Giving feedback, Guidance
Link Reference: 616
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Guidance for site study teams and sponsors for remote monitoring and source data verification within Barts Health NHS Trust
Type: Example Guidance
Author: Joint Research Management Office, Queen Mary University of London and Barts Health NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring, monitoring, SDV, IG
Link Reference: 2885
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Guidance on the Scanning and Destruction of Original Paper eTMF Records, published April 2017
Type: Guide
Author: Health Sciences Records & Archives Association
Keywords: eTMF, scanning, original records, archiving, records management, trial master file, data, destruction, source, GCP
Link Reference: 766
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Guidance on the use of social media to actively involve people in research
Type: Guidance
Author: NIHR INVOLVE
Keywords: social, media, public, involvement,
Link Reference: 152
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Guide for Excess Treatment Costs
Type: Guidance
Author: NHS England
Keywords: excess, cost, attribution, ETC
Link Reference: 166
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Guide for regulatory Inspections
Type: Guidance
Author: NHS R&D Forum
Keywords: GCP, MHRA, inspection, sponsor, host
Link Reference: 496
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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols The SPIRIT-PRO Extension
Type: Guideline
Author: Melanie Calvert, PhD; Derek Kyte, PhD; Rebecca Mercieca-Bebber, PhD; et al
Keywords: PRO, SPIRIT-PRO, SPIRIT Guidelines, Protocol, Clinical Trials, Patient Report Outcomes
Link Reference: 608
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GxP Data Integrity Guide: Launched March 2018
Type: Guidance
Author: MHRA
Keywords: Data management, data integrity, data, MHRA, GCP, GxP
Link Reference: 618
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Health & Care Research Wales
Type: Website resources
Author: Health & Care Research Wales
Keywords: Funding, Grants, Awards, Award Schemes, Wales
Link Reference: 361
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Health & Care Videos for Clinical Trials
Type: Video
Author: Health & Care Videos
Keywords: Video production, information production, participant information, research design, communication, research communication, embedding research, accessibility
Additional Detail: Commercial facility
Link Reference: 585
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Health Care Leadership Model App
Type: Tool
Author: NHS Leadership Academy
Keywords: Leadership, skills, competencies, teams, management
Link Reference: 3636
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Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey
Type: Article
Author: Victoria Shepherd, Richard Griffith, Mark Sheehan, Fiona Wood, Kerenza Hood
Keywords: consent, mental incapacity, adults, capacity to consent. health care professionals. legislation, understanding the law,
Link Reference: 636
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Healthwise Wales
Type: Website resources
Author: Health & Care Research Wales
Keywords: Data sharing, e-research, data platform, informatics, data banks
Link Reference: 383
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How Alder Hey hospital enabled research time for healthcare professionals
Type: Video
Author: RCP/Louise Shepherd CBE, chief executive, Alder Hey Children’s Hospital.
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2827
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How District General Hospitals can become more research active: A Trust CEO perspective
Type: Video
Author: RCP/Simon Constable FRCP, Chief Executive, Warrington & Halton Teaching Hospitals NHS Foundation Trust
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2826
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How does the NHS in England Work? An alternative guide
Type: Video
Author: Kings Fund
Keywords: NHS landscape, NHS England, NHS structure
Link Reference: 526
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How the new NHS is structured
Type: Video
Author: Kings Fund
Keywords: NHS landscape, NHS England, NHS structure, NHS funding
Link Reference: 605
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How the NIHR CRN will capture research activity data – February 2019
Type: Video
Author: NIHR CRN
Keywords: CPMS, LPMS, recruitment data, activity data, performance monitoring, performance
Link Reference: 730
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How to apply for NIHR CRN support
Type: Website resources
Author: NIHR CRN
Keywords: NIHR, portfolio, support
Link Reference: 360
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How to complete a SoECAT
Type: Guidance
Author: DHSC non commercial costings group
Keywords: AcoRD, costing, cost attribution, FAQs, SoECAT
Link Reference: 2834
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How to identify existing studies open to new sites using Open Data Platform and UK Clinical Trials Gateway
Type: Website resources
Author: NIHR CRN
Keywords: finding studies, open studies, CRN research, portfolio studies, ODP, UKCTG
Additional Detail: https://www.nihr.ac.uk/research-and-impact/nihr-clinical-research-network-portfolio/
Link Reference: 382
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How to set up a stakeholder advisory panel for your research and why it actually delivers impact
Type: Article
Author: Fast Track Impact
Keywords: IMPACT, stakeholder involvement, developing research, PPI, research engagement, partnerships
Link Reference: 607
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How to tackle clinical trials transparency: University of Bristol Case Study via Transpirimed.
Type: Example
Author: Tranparimed and University of Bristol
Keywords: transparency, quality, integrity, study registrations, trials registration
Link Reference: 681
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How to upload results and update entries on clinical trial registers
Type: Guidance
Author: All Trials
Keywords: research transparency, research reporting,clinical trial register, EudraCT, transparency, quality, integrity, study registrations, trials registration, CTIMPS, All Trials
Link Reference: 743
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How we conduct risk assessment
Type: Example risk assessment
Author: Christie NHS Trust
Keywords: risk assessment, risk, sponsorship, sponsors, study review, sponsor assessment
Additional Detail: Supports a slide set from the non-commercial Sponsors symposium November 2019 https://www.rdforum.nhs.uk/content/2019/11/27/non-commercial-sponsors-symposium-slides/
Link Reference: 2843
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How we let you know about Research
Type: Example Video
Author: Avon & Wiltshire Mental Health Partnership NHS Trust
Keywords: Access, opportunity, equality, everyone, inclusion, mental health
Additional Detail: Supporting access to research opportunities via the research office
Link Reference: 221
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HRA amendments Workflow & Metrics for Edge Users (Chelsea & Westminster, NHS Foundation Trust)
Type: Guidance
Author: Chelsea & Westminster NHS Foundation Trust
Keywords: amendment, EDGE, workflow, classification
Additional Detail: For R&D office staff
Link Reference: 328
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HRA applications, get it right first time
Type: Slide set
Author: Health Research Authority
Keywords: HRA approval, study set up, getting it right, research applications
Link Reference: 634
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HRA Approval & NIHR metrics
Type: Guidance
Author: NIHR & HRA
Keywords: Performance, Metrics, PID, Targets
Link Reference: 425
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HRA Approval all you need to know
Type: Website resources
Author: Medical Research Council
Keywords: MRC, HRA, regulatory, support, approval
Link Reference: 324
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HRA Approval Workflow & Metrics for Edge Users
Type: Guidance
Author: Chelsea & Westminster NHS Foundation Trust
Keywords: HRA, approval, workflow, assessing, arranging, capacity, capability, EDGE
Additional Detail: For R&D office staff
Link Reference: 329
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HRA Approval: All you need to know.
Type: Guidance
Author: Medical Research Council
Keywords: HRA, HRA Approval, Research approval, Regulatory approval
Link Reference: 495
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HRA Approval: Assessment criteria
Type: Guidance
Author: Health Research Authority
Keywords: HRA, assessment, approval, criteria, standards
Link Reference: 326
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HRA Approval: Making an application
Type: Website resources
Author: Health Research Authority
Keywords: HRA, HRA Approval, Research approval, Regulatory approval
Link Reference: 501
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HRA Approval: Training Resources
Type: Training Course
Author: Health Research Authority
Keywords: HRA, HRA Approval, Research approval, Regulatory approval, training, Sponsorship, Chief Investigators
Additional Detail: Resources and leaflets as well as resources
Link Reference: 480
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HRA assessment criteria and standards
Type: Guidance
Author: Health Research Authority
Keywords: HRA approval, Sponsorship, Standards, research approval
Link Reference: 491
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HRA bite sized e learning for students and their supervisors/sponsors
Type: Training Course
Author: Health Research Authority
Keywords: elearning
Link Reference: 706
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HRA Public Involvement Guidance for Research Applicants:
Type: Guidance
Author: Health Research Authority
Keywords: IRAS, research ethics, PPI, REC application, research application, HRA application
Link Reference: 651
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HRA training for researchers
Type: Slide set
Author: HRA
Keywords: HRA, eLearning, module, training
Link Reference: 201
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HRA: GDPR webinar slide set
Type: Slide set
Author: Health Research Authority
Keywords: GDPR, information governance, data protection, data regulation, consent, lawful basis, safeguard,s transparency, UK legislation
Additional Detail: Please note that these slides are date specific (May 2018( and will change/be replaced over time
Link Reference: 641
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HRMR Guidance Pack for designing, conducting & overseeing clinical trials
Type: Guidance
Author: MRC Hubs for Trials Methodology Research
Keywords: Design, conduct, oversight, clinical trials, trials design, research oversight
Link Reference: 630
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HSJ Clinical Research Impact Awards
Type: Award scheme
Author: HSJ
Keywords: HSJ, award, impact, clinical, research
Link Reference: 220
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Hub & spoke model in primary care
Type: Slide set
Author: Nottingham City CCG
Keywords: hub, spoke, model, primary,delivery,Nottingham
Link Reference: 182
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I am Research Campaign 2018 and NHS 70 campaign highlights
Type: Infographic
Author: NIHR
Keywords: promoting, social media, campaigns. embedding, research culture
Link Reference: 684
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ICH E6 (r2)
Type: Guideline
Author: ICH
Keywords: ICH, GCP, E6, addendum, guideline
Link Reference: 321
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Ideal Framework for surgical therapy innovations
Type: Guidance
Author: IDEAL Collaboration
Keywords: Idea, Development, Exploration, Assessment, Long-term Follow-up, Improving, quality, surgery, framework, IDEAL
Link Reference: 461
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IDEAL Framework update: No surgical innovtion without evaluation
Type: Article
Author: IDEAL collaboration
Keywords: Surgical research, devices, research pathway, ideal framework, ideal
Link Reference: 726
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IMP management for Trust Sponsored studies
Type: Example SOP
Author: Barts Health NHS Trust & Queen Mary University of London
Keywords: Sponsorship, IMP management, GCP, Compliance, CTIMPS
Link Reference: 299
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IMP: Clinical Trials Toolkit Trial Supplies Guide
Type: Guidance
Author: MODEPHARMA for the NIHR Clinical Trials Toolkit via Clinical Trials Toolkit
Keywords: Sponsorship, Trials Supplies, IMP management, CTIMPS, GCP, Compliance, Risk adaption
Link Reference: 300
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Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis
Type: Article
Author: Joanna C Crocker, research fellow, Ignacio Ricci-Cabello, Miguel Servet research fellow, Adwoa Parker, research fellow, Jennifer A Hirst, senior researcher, Alan Chant, patient partner, Sophie Petit-Zeman, former director of patient involvement, David Evans, professor in health services research, Sian Rees, patient and public involvement, engagement and experience theme lead
Keywords: PPI, patient and public involvement, enrolment, retention, trial retention, project management, sponsorship
Link Reference: 711
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Impact Planning Tool
Type: Website resources
Author: Fast Track Impact
Keywords: impact, plan, planning, tool, matrix
Link Reference: 392
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Implementing Amendments at NHS Sites
Type: Example Tool
Author: Health Research Authority
Keywords: Sponsorship, Sponsors, amendments, site set up, capacity and capability, email templates, notifications
Additional Detail: Scroll to the end of the page
Link Reference: 584
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Implications of the COVID-19 outbreak for clinical research at North Bristol NHS trust Guidance for our investigators and research staff
Type: Example Guidance
Author: North Bristol NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent
Link Reference: 2849
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Improving healthcare through clinical research
Type: Website resources
Author: NIHR
Keywords: improving, healthcare, clinical, research, online, course,Future Learn
Link Reference: 206
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Improving the Health of the Public by 2040
Type: Report
Author: Academy of Medical Sciences
Keywords: Academy, health, public, science, 204, challenges
Link Reference: 247
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Include Ethnicity Framework
Type: Toolkit
Author: NIHR and TrialForge
Keywords: Inclusion, diversity, ethnicity, involvement, Sponsorship, design, research design.
Link Reference: 3635
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Income distribution from NIHR CRN Industry Portfolio Studies
Type: Guidance
Author: NIHR Clinical Research Network
Keywords: Industry studies, income distribution, finance management
Link Reference: 169
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Increasing patient benefit through gaining University Status for an NHS Trust
Type: Slide set
Author: East & North Herts NHS Trust & University of Hertfordshire
Keywords: patient benefit; university status; increasing
Link Reference: 523
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Induction pack for PPI contributors on Trial Oversight Committees
Type: Tool
Author: MRC CTU at UCL
Keywords: PPI, induction, induction pack Trial oversight committees, Patient and Public Involvement
Link Reference: 692
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Infographic on the research grant application and funding process top tips for home-grown studies
Type: Infographic
Author: Paul Roberts, Mid Essex Hospital Services NHS Trust
Keywords: In house studies, research funding, funding process, home-grown research top tips, local research
Link Reference: 623
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Information Governance Toolkit
Type: Website resources
Author: NHS Digital
Keywords: information, governance, toolkit, data, security
Additional Detail: Requires a registration
Link Reference: 332
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Informed consent
Type: Website resources
Author: NIHR via clinical trials toolkit
Keywords: Informed consent, consent, data sharing, clinical research, mental capacity, CTIMPS, GCP,
Link Reference: 270
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Innovations Toolkit
Type: Website resources
Author: Walton Centre NHS Foundation Trust & NW Coast AHSN
Keywords: innovation, toolkit, Walton, academic
Link Reference: 512
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Inspiring Research
Type: Bright Talk
Author: NIHR Clinical Research Network
Keywords: inspire, inspiring, bright, passion, research, Sussex
Link Reference: 223
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Institute of Health Care Improvement
Type: Website resources
Author: IHI
Keywords: independent, health healthcare, institute, improvement
Link Reference: 231
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Institute of Health Care Management
Type: Website resources
Author: IHM
Keywords: independent, healthcare, management, social care
Link Reference: 422
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Integrated Research Ethics Application System (IRAS)
Type: Website resources
Author: IRAS
Keywords: IRAS, application, forms, approvals
Additional Detail: IRAS captures the information needed for the relevant approvals from the following review bodies:
Link Reference: 343
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Integrated Workforce Framework
Type: Website resources
Author: NIHR CRN
Keywords: integrated, workforce, framework, NIHR, IWF,
Link Reference: 423
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Integrity in Practice toolkit
Type: Toolkit
Author: UKRIO and the Royal Society
Keywords: Research integrity, transparency, embedding
Link Reference: 694
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Integrity in Practice Toolkit
Type: Toolkit
Author: UKRIO and Royal Society
Keywords: Research integrity, transparency, embedding
Link Reference: 798
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Intellectual Property Rights
Type: Video
Author: Intellectual Property Office UK
Keywords: Intellectual Property Rights, IP, IPR, Patents, Design Rights , Trademarks, Copyright
Additional Detail: Via twitter only
Link Reference: 10665
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Introducing AHNS and Embedded Research
Type: Slide set
Author: RCP/Innovation Agency: Dr Liz Mears
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2822
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Investigator Site File Contents
Type: Example Form
Author: University Hospital Bristol NHS Foundation Trust
Keywords: Bristol, site, file, index, contents
Additional Detail: Includes delegation log template
Link Reference: 287
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INVOLVE
Type: Website resources
Author: NIHR
Keywords: involve, public, involvement, health, social care, PPI
Link Reference: 260
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Involvement Portfolio
Type: Tool
Author: NHS R&D Forum
Keywords: volunteer, carer, service user, record, voluntary, involve, PPI
Additional Detail: For recording involvement in research as a Service User & Carer
Link Reference: 262
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Involving NHS staff in research
Type: Report
Author: THIS Institute and RAND
Keywords: Staff engagement, involvement, embedding, strategies, strategy, communications, clinical researchers, clinical research, nhs research
Link Reference: 732
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Involving people in laboratory based research
Type: Paper
Author: Shared Learning Group on involvement in research
Keywords: PPI, Service users, laboratory research, involvement
Link Reference: 264
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Involving Service Users and Carers as Co-Applicants, Project Team Members and Co-researchers in Research Guidelines for Sponsors, Research Managers and Governance Leads
Type: Guidance
Author: NHS R&D Forum Service Users and Carers Working Group
Keywords: Coapplicancy, co-applicants, PPI, patient and public involvement, consumers, service users and carers, ethics, governance, legal
Link Reference: 2838
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IP policy
Type: Example Policy
Author: Hartlepool and Stockton on Tees CCG
Keywords: IP, intellectual, revenue, Hartlepool, Stockton
Link Reference: 171
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IP policy
Type: Example Policy
Author: University Hospital Bristol NHS Foundation Trust
Keywords: IP, intellectual, costing, Bristol, policy
Link Reference: 173
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Is my study research?
Type: Guidance
Author: Medical Research Council/Health Research Authority
Keywords: MRC, HRA, categorise, service evaluation, audit, decision tool
Link Reference: 372
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Is this what we should all know
Type: Blog
Author: Derek Stewart
Keywords: public, patient, blog, Derek, involvement, PPI
Link Reference: 259
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Is your app a medical device?
Type: Article
Author: MHRA
Keywords: app, device, MHRA, blog,
Link Reference: 440
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ISRCTN & Portfolio adoption
Type: Website resources
Author: NIHR CRN
Keywords: Research Registration, ISRCTN, Sponsorship, Portfolio adoption,
Additional Detail: https://www.nihr.ac.uk/research-and-impact/nihr-clinical-research-network-portfolio/isrctn-registration.htm
Link Reference: 467
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James Lind Alliance: Priority Setting Partnerships
Type: Website resources
Author: NIHR
Keywords: Research priorities, priority setting, research gaps, research questions, funding
Additional Detail: http://www.jla.nihr.ac.uk/priority-setting-partnerships/
Link Reference: 380
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Join Dementia Research
Type: Website resources
Author: NIHR
Keywords: dementia, register
Link Reference: 384
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Joint Research Office
Type: Example website
Author: Birmingham Health Partners
Keywords: Birmingham, partners, joint, office
Link Reference: 178
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Joint Research Office
Type: Example website
Author: Great Ormond Street Hospital for Children NHS Foundation Trust & ICH
Keywords: Ormond, GOSH, UCL, Child Health, joint, office
Link Reference: 179
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Joint Research Office
Type: Example website
Author: University College London, UCL Hospitals NHS Foundation Trust & Royal Free London NHS Foundation Trust
Keywords: JRO, joint, office, UCL,Hampstead
Link Reference: 180
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Joint Research Office
Type: Example website
Author: Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust
Keywords: joint, office, Newcastle
Link Reference: 181
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Joint Statement on the Application of Good Clinical Practice to Training for Researchers
Type: Guidance
Author: HRA/MHRA/UK Devolved Administrations
Keywords: GCP, Training, Compliance, Teams, Development, Induction
Link Reference: 573
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joint Statement on the Application of Good Clinical Practice to Training for Researchers
Type: Guidance
Author: hRA/MHRA/UK Devolved Administrations
Keywords: GCP, Training, Compliance, Teams, Development, Induction, Non-CTIMP
Link Reference: 579
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JRO SOP for peer review of studies sponsored by UCL and UCLH
Type: Example SOP
Author: UCLH & UCL
Keywords: SOP, peer, review, joint, sponsor
Link Reference: 389
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Laboratory Checklist for GCP compliance
Type: Example checklist
Author: York Hospitals NHS Trust
Keywords: lab, checklist, GCP, compliance, York, SOP
Link Reference: 443
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Lambert Toolkit
Type: Website resources
Author: IP Office
Keywords: Lambert, toolkit, university, business, collaboration, contract, decision guide
Link Reference: 159
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Leadership Model
Type: Website resources
Author: Leadership Academy
Keywords: leadership, model, NHS, healthcare, dimensions
Link Reference: 189
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Leadership Online: A Directory of Resources
Type: Toolkit
Author: John Hunt: Leadership Online
Keywords: Leadership, resources, tools, toolkit, leaders, management, skills,
Additional Detail: Please note: This work is licenced under a “Creative Commons Attribution-NonCommercial-ShareAlike 2.0 UK: England & Wales License”. If used or adapted in a form other than as this document itself or on an agreed website, the following wording should be used: “This work has been made available by permission of John Hunt” and this licence logo should be displayed.
Link Reference: 664
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Leading large scale change
Type: Guide
Author: NHS England
Keywords: leading change, change management, influencing, leadership, leading research
Link Reference: 596
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Learning for involvement website
Type: Website resources
Author: NIHR INVOLVE
Keywords: PPI, researchers, toolkit, patient and public involvement, engagement, participation, involvement, learning, training, professional development, learning and development
Link Reference: 741
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Learning Management System
Type: Website resources
Author: Health Research Authority
Keywords: Learning, development, training, learning management, resources, elearning
Link Reference: 742
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Leeds Teaching Hospital NHS Trust Innovation Strategy
Type: Example Strategy document
Author: Leeds Teaching Hospital NHS Trust
Keywords: innovation, strategy, Leeds
Link Reference: 511
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Leeds Teaching Hospital Research and Innovation Strategy 2015-2020
Type: Example Strategy document
Author: Leeds NHS Trust
Keywords: research strategy, innovation
Link Reference: 517
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Lessons learnt from succesfully implementing a Research Strategy
Type: Slide set
Author: East and North Hertfordshire NHS Trust
Keywords: Research Strategy Patient Benefit
Link Reference: 788
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Lets Talk Research Podcasts
Type: Example Video
Author: North West R&D
Keywords: promoting research, podcast
Link Reference: 218
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Letter providing further details on Restart and Reset for Research
Type: Example Guidance
Author: Newcastle Joint Research Office
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, restart, reset, communication to PIs
Additional Detail: Please note the date of publication
Link Reference: 2873
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Liberating Structures
Type: Website resources
Author: Liberating structures
Keywords: Facilitation, leadership, skills, promoting, communication, engaging, embedding research
Link Reference: 665
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Life Sciences Sector Deal
Type: Policy
Author: UK Government
Keywords: life sciences, sector deal, landscape, strategy, industrial strategy, growth, partnerships
Link Reference: 717
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List of types of agreement used in clinical research
Type: Website resources
Author: Clinical Trials Toolkit
Keywords: toolkit, routemap, contract, agreement
Link Reference: 156
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Local Support Functions in a Primary Care Research Office Part 2
Type: Guidance
Author: NHS R&D Forum Primary Care & Commissioning Working Group
Keywords: primary care research offices, HRA approval, R&D support functions, CCGs, research management, research offices
Additional Detail: This is part 2 of a paper
Link Reference: 587
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Local support functions in primary care R&D offices v2 December 2017
Type: Guidance
Author: NHS R&D Forum Primary Care & Commissioning Working Group
Keywords: Primary care research offices, HRA approval, R&D support functions, CCGs, research management, research offices
Additional Detail: Please note there is a second paper with appended roles
Link Reference: 586
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Local support functions in primary care R&D offices following implementation of HRA approval
Type: Guidance
Author: R&D Forum
Keywords: local, support, primary care, function, HRA, approval
Link Reference: 240
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Looking into a crystal ball for clinical research and development — December 18
Type: Blog
Author: Cat Ball, Senior Policy Manager AMRC
Keywords: Strategy, future, research strategy, clinical research, future of clinical research
Link Reference: 713
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Make Space4Research: Why its important for staff to be given the time and opportunity to make space for research.
Type: Video
Author: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Keywords: embedding research, research and care, staff, staff time, make space, time, research time
Link Reference: 756
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Making data count
Type: Tool
Author: NHS Improvement
Keywords: data, performance, information, business, intelligence
Link Reference: 652
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Making GCP training relevant and applicable: its not just for clinical staff
Type: Blog
Author: MHRA
Keywords: GCP, GCP training, Research operations, staff, training, CTIMPS, Sponsor, Host
Link Reference: 696
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Managing conflicts of interest in the NHS: Guidance of staff & organisations
Type: Guidance
Author: NHSE
Keywords: Conflicts of interest, guidance, staff, COI, research income
Link Reference: 597
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Managing Excess Treatment Costs in non-commercial research: Outcome of the national consultation. A Briefing Note for R&D management staff.
Type: Guidance
Author: NHS R&D Forum
Keywords: ETCs, Excess Treatment Costs, Funding research, AcoRD, costings, finance, financial management,
Link Reference: 669
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Managing Intellectual Property in R&D
Type: Slide set
Author: Karen Underwood
Keywords: Intellectual Property, IPR, Rights, Collaborations, Agreements, Grants
Link Reference: 301
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Managing research data in your institution
Type: Guidance
Author: JISC
Keywords: manage, managing, data, JISC
Link Reference: 283
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Medical Devices: Notify MHRA about a Clinical Investigation of a Medical Device
Type: Guidance
Author: MHRA
Keywords: notify, MHRA, clinical, device, investigation, regulatory
Link Reference: 339
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Medical Devices: Questions & Answers
Type: Website resources
Author: HRA
Keywords: device, question, HRA, apply, MHRA
Link Reference: 337
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Mentoring Resources
Type: Website resources
Author: Academy of Medical Sciences
Keywords: Mentoring, mentorship, skills, help, resources
Link Reference: 10661
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Methodology training courses
Type: Website resources
Author: MRC
Keywords: methodology, hub, MRC, training,resources, course, trials
Link Reference: 207
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MHRA GCP Symposium 2020
Type: Blog
Author: MHRA
Keywords: GCP. international collaboration, Sponsor oversight, e-source, protocol deviations, data quality, novel designs
Link Reference: 2881
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MHRA and FDA Joint Paper ‘Data Integrity in Global Clinical Trials’
Type: Blog
Author: MHRA and FDA
Keywords: GCP. international collaboration, data integrity, global trials
Link Reference: 2882
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MHRA Blog: Sponsors Oversight Part 1
Type: Blog
Author: MHRA
Keywords: Sponsorship, oversight, audit, monitoring, quality, risk, sponsors, regulation, GCP, clinical trials
Link Reference: 660
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MHRA GCP inspections with Jason Wakelin-Smith
Type: Website resources
Author: NIHR: Allan Gaw & Jason Wakelin-Smith
Keywords: Inspections, GCP inspections, MHRA, Regulatory Ready, Understanding GCP inspections
Additional Detail: Podcast
Link Reference: 612
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MHRA GXP Data Integrity Guidance: Part 1 – A GCP Perspective
Type: Blog
Author: MHRA
Keywords: Data management, data integrity, data, CTIMPS, Sponsorship
Link Reference: 748
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MHRA GXP Data integrity guide for industry
Type: Guidance
Author: MHRA
Keywords: MHRA, GxP, data, integrity, definition, guidance, industry,
Link Reference: 282
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MHRA Position Paper & Guidance: Electronic Health Records
Type: Paper
Author: MHRA
Keywords: MHRA, Electronic Health Records, GCP, EHR
Link Reference: 317
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Monitoring & Audit Policy
Type: Example Policy
Author: Norfolk & Suffolk NHS Foundation Trust
Keywords: Norfolk, Suffolk, audit, monitoring,
Link Reference: 493
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Monitoring & Oversight of Research Activity
Type: Example SOP
Author: University Hospitals Bristol NHS Foundation Trust
Keywords: Bristol, SOP, monitoring, oversight
Link Reference: 503
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Monitoring Advances Including Consent; Learning from COVID-19 Trials and Other Trials Running in UKCRC Registered Clinical Trials Units During the COVID-19 Pandemic
Type: 
Author: Sharon Love, Emma Armstrong, Carrie Bayliss, Melanie Boulter, Lisa Fox, Joanne Grumett, Patricia Rafferty, Barbara Temesi, Krista Wills, Andrea Corkhill
Keywords: monitoring, econsent, consent, remote monitoring, COVID, COVID-19
Link Reference: 2890
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Monitoring during COVID 19 at GSTFT.
Type: Example Guidance
Author: Guy’s & St Thomas’ NHS Foundation Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring, re-start, restart
Link Reference: 2878
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Monitoring Plan template
Type: Example Form
Author: University Hospitals Leicester NHS Trust
Keywords: Leicester, monitoring, plan, template
Link Reference: 497
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Monitoring SOP
Type: Example SOP
Author: University Hospitals Leicester NHS Trust
Keywords: Leicester, SOP, management, monitoring
Link Reference: 500
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Monitoring strategy table
Type: Example Strategy
Author: University Hospitals Leicester NHS Trust
Keywords: Leicester, trial, monitoring, strategy, CTIMP
Link Reference: 498
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Monitoring Systems
Type: Paper
Author: NHS R&D Forum
Keywords: monitor, audit, quality
Link Reference: 502
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Monitoring visit report
Type: Example Form
Author: University Hospitals Leicester NHS Trust
Keywords: UHL, monitor, visit, template
Link Reference: 499
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Monitoring, Audit & Inspection
Type: Website resources
Author: NOCOR Research Support
Keywords: Monitoring, Audit, Inspection
Link Reference: 494
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MRC careers skills funding framework
Type: Website resources
Author: Medical Research Council
Keywords: MRC, career, funding, framework
Link Reference: 358
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MRC Fourth guidance note: Safeguards and approvals for GDPR
Type: Guidance
Author: Medical Research Council
Keywords: GDPR, information governance, data protection, data regulation, safeguards
Link Reference: 640
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MRC Guidelines for the management of global health trials involving clinical or public health interventions
Type: Guidance
Author: Medical Research Council
Keywords: GCP, Sponsorship, Oversight, Management, Clinical Trials, Global. Health trials
Additional Detail: 2017
Link Reference: 409
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MRC hub for trials methodology research
Type: Website resources
Author: Medical Research Council
Keywords: MRC, hub, network, adaptive, recruitment
Link Reference: 394
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MRC Regulatory Support Centre: Retention framework for research data and records
Type: Guidance
Author: Medical Research Council
Keywords: Information governance, data retention, framework, guidance
Link Reference: 333
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Multi-stake holder health research systems. What do we know about working in partnership
Type: Slide set
Author: Professor Trish Greenhalgh
Keywords: stakeholder, partnership, Greenhalgh, system, presentation
Additional Detail: Includes a detailed history timeline
Link Reference: 248
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National Data Opt Out
Type: Website resources
Author: NHS digital
Keywords: Data opt out, national data opt out, NHS digital
Link Reference: 628
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National Model Template Agreements
Type: Tool
Author: NIHR Clinical Research Network
Keywords: Model agreements, contracts, agreements, templates
Link Reference: 157
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National Standards for Public Involvement in Research
Type: Guidance
Author: Standards Development Partnership
Keywords: PPI. standards, embedding research, value, public involvement, involvement
Link Reference: 620
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Negotiating Contracts
Type: Bright Talk
Author: NIHR Clinical Research Network
Keywords: negotiate, negotiating, contracts, agreements, commercial, costing,
Link Reference: 158
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New licensing system for ARSAC
Type: Blog
Author: Department of Health
Keywords: ARSAC, IRMER, Regulation, Approvals, Licensing
Link Reference: 580
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NHS constitution
Type: Policy
Author: Dept. Health
Keywords: constitution, NHS, government, England
Link Reference: 255
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NHS Constitution Hand Book for England
Type: Policy
Author: Dept. Health
Keywords: NHS, constitution, principles, values, guide
Link Reference: 251
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NHS Digital reform: Enabling clinical trials
Type: Slide set
Author: MHRA
Keywords: Wakelin, digital, clinical, trials, enabling, reform, MHRA
Link Reference: 351
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NHS Improvement Directory
Type: Website resources
Author: NHS Institute for innovation & improvement
Keywords: improvement, hub, resource, directory
Link Reference: 234
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NHS indemnity. Arrangements for Clinical Negligence Claims in the NHS
Type: Policy
Author: NHS LA
Keywords: indemnity, claim, negligence, nhsla
Link Reference: 441
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NHS Library and Knowledge Servcies
Type: Policy
Author: Health Eduation England, NHS Library and Knowledge Services
Keywords: NHS Library and Knowledge Services,
Additional Detail: Health Education England’s policy sets out the approach to delivering on the key objective of enabling access to knowledge and evidence for healthcare decision makers.
Link Reference: 676
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NHS Library and Knowledge Services
Type: Website resources
Author: Health Education England, NHS Library and Knowledge Services
Keywords: NHS Library and Knowledge Services, Knowledge Mobilisation, Evidence Based Practice, Critical Appraisal, Evidence Resources
Additional Detail: Use the website to link up with your local NHS Library and Knowledge Service to discover how they can work with you to support research and innovation, quality improvement adn knowledge mobil
Link Reference: 678
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NHS Social Media support
Type: Website resources
Author: #nhssm
Keywords: Twitter, Facebook, Snapchat, Video
Link Reference: 150
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NHSE commissioning policy. Continuing funding after completion of a clinical trial
Type: Policy
Author: NHS England
Keywords: funding, treatment costs, ongoing treatment costs, financial management, finance, costings, commissioning
Link Reference: 613
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NIHR – Use of Open Researcher and Contributor ID (ORCID)
Type: Website resources
Author: NIHR
Keywords: 
Link Reference: 359
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NIHR Adding Value in Research
Type: Website resources
Author: NIHR
Keywords: value, research, funding, patients, public, maximise
Link Reference: 485
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NIHR Clinical Research Network Health Services Research Toolkit.
Type: Toolkit
Author: NIHR
Keywords: design, methods, PPI, Grant funding, dissemination, health services research
Link Reference: 772
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NIHR CQC partnership webpages
Type: Website resources
Author: NIHR
Keywords: well led, organisational leadership, quality organisations, research active organisations, CQC, inspection,
Link Reference: 722
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NIHR CRN Allied Health Professionals Strategy 2018:2020
Type: Example Strategy
Author: NIHR CRN
Keywords: AHPs, Research time, Researcher development, growing research capability, developing AHP researchers
Link Reference: 604
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NIHR CRN Health Services Research Toolkit.
Type: Website resources
Author: NIHR CRN Health Services Research: Health Services Research Speciality
Keywords: Health services research, HSR, research design, research for health
Additional Detail: The Health Services Research Specialty is one of 30 communities, made up of active health services researchers nationally.
Link Reference: 626
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NIHR CRN Industry costing template
Type: Tool
Author: NIHR CRN
Keywords: costings, template,
Link Reference: 164
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NIHR Current funding opportunities
Type: Website resources
Author: NIHR
Keywords: Grant; funding; call;
Link Reference: 415
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NIHR Dissemination Centre
Type: Website resources
Author: NIHR
Keywords: Dissemination; publication
Link Reference: 257
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NIHR Framework for Restart: Information Sheet for GPS
Type: Example Leaflet
Author: Norfolk & Suffolk Primary & Community Care Research Office, Cambridge & Peterborough Primary Care, NIHR CRN Eastern
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, re-start, risk assessment, start, set up, sites, pause,research
Link Reference: 2877
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NIHR Hub
Type: Website resources
Author: NIHR
Keywords: Hub
Link Reference: 434
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NIHR Involve guidance on Public Co-applicants in Research – Guidance on Roles & Responsibilities
Type: Guidance
Author: NIHR, HRA and NHS R&D Forum
Keywords: PPI, leading research, embedding research, co-production, service users and carers
Link Reference: 2839
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NIHR Journals Library
Type: Website resources
Author: NIHR
Keywords: Publication, journal, dissemination
Link Reference: 258
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NIHR Research Activity League Table 2016-2017
Type: Website resources
Author: NIHR CRN
Keywords: performance; metrics; table; league
Link Reference: 428
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NIHR Response to COVID-19
Type: Guidance
Author: NIHR
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, restart. pause,
Link Reference: 2876
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NIHR RSS Competency Framework for R&D Staff
Type: Toolkit
Author: Developed with DH RSS Champions (Now HRA RSS Champions)
Keywords: Competencies, knowledge, skills, research management, research support, RSS framework
Link Reference: 417
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NIHR trainees Co-ordinating Centre
Type: Website resources
Author: NIHR
Keywords: 
Link Reference: 414
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NIHR welcomes life sciences sector deal 2
Type: Article
Author: Prof Chris Whitty, UK Gov CSA and Emma Lowe, Policy manager DHSC
Keywords: strategy, industry, industrial strategy, life sciences, context, landscape, sector deal,
Link Reference: 716
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NOCLOR Research Life Cycle interactive infographic
Type: Infographic
Author: NOCLOR
Keywords: resource, illustration, infographic, knowledge
Link Reference: 199
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Non commercial sponsors symposium 2019: slide set
Type: Slide set
Author: NHS R&D Forum Non Commercial Sponsors
Keywords: Sponsorship, transparency, EudraCT, reporting, registration, decision to sponsor, risk assessment, ATMPS, Device regulations, device studies, data sharing, data, HRA, safety measures, root cause analysis,
Link Reference: 2842
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Non-Commercial Sponsors Symposium Output
Type: Website resources
Author: NHS R&D Forum
Keywords: Non commercial sponsor symposium good sponsorship
Link Reference: 687
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Norfolk and Suffolk R&D Office for Primary and Community Care 2017-2018 Annual Report
Type: Example Report
Author: Norfolk and Suffolk R&D Office for Primary & Community Care
Keywords: annual report, performance, communications, engaging, influencing, metrics,
Link Reference: 662
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North Bristol NHS Trust Research Strategy
Type: Example Strategy document
Author: North Bristol NHS Trust
Keywords: research strategy, innovation
Link Reference: 516
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North Bristol Setting up new studies where NBT are sponsor 14.12.16
Type: Example Tool
Author: North Bristol NHS Trust
Keywords: Sponsorship, set up, process, Sponsors, sponsor process,
Link Reference: 690
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North West R&D
Type: Training Course
Author: North West R&D – Upcoming Events
Keywords: training, research
Link Reference: 198
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Nottingham is Research: A People Strategy
Type: Example Strategy
Author: Derek Stewart, NIHR Nottingham Biomedical Research Centre
Keywords: PPI. strategy, people strategy, embedding research, value, public involvement, involvement, biomedical research, clinical research facilities
Link Reference: 632
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Nottingham University Hospitals Trust Research & Innovation Dept Annual report 19-20
Type: Example Report
Author: Nottingham University Hospitals NHS Trust
Keywords: Annual report, embedding research, embed research, performance,
Link Reference: 2901
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On Site Monitoring Letter
Type: 
Author: Royal Papworth Hospital
Keywords: Monitoring, COVID-19, external visitors, monitors, code of conduct, on-site monitoring
Link Reference: 2892
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Open Data Platform (ODP)
Type: Website resources
Author: NIHR
Keywords: metrics,ODP, performance
Link Reference: 429
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Our driven future: People and partnerships at the heart of health related technologies
Type: Report
Author: Academy of Medical Sciences
Keywords: strategy, landscape, data, data driven tech, people, partnerships, research, evaluation, public involvement, PPI
Link Reference: 720
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P Smith et al Development of a Research Strategy HJM 2016
Type: Article
Author: East and North Hertfordshire NHS Trust
Keywords: Research Strategy Implementation
Link Reference: 785
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Paper based randomisation
Type: Example SOP
Author: Cambridge University Hospitals NHS Foundation Trust
Keywords: Randomisation, SOP
Link Reference: 235
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Paper on Risk Adaption for CTIMPS
Type: Guidance
Author: MRC/DH/MHRA
Keywords: CTIMPs, Risk Assessment, MHRA
Link Reference: 473
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Patient & Public Involvement Handbook
Type: Guidance
Author: NIHR Research Design Service
Keywords: Patient and Public Involvement, PPI, Research Design Service
Link Reference: 263
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Patient and public involvement for ethnic minority research: an urgent need for improvement.
Type: Paper
Author: Ekezie W, Routen A, Denegri S, Khunti K. Journal of the Royal Society of Medicine. February 2021. doi:10.1177/0141076821994274
Keywords: Inclusion, diversity, ethnicity, involvement, Sponsorship, design, research design. PPI, PPIE, ethnic minorites, involvement
Link Reference: 10660
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Patient involvement toolkit for researchers (updated Dec 2018)
Type: Toolkit
Author: Cancer Research UK
Keywords: PPI, researchers, toolkit, patient and public involvement, engagement, participation, involvement
Link Reference: 712
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Patient powered research: Recognising the power of lived experience in health research.
Type: Blog
Author: Dr Bella Starling
Keywords: PPI, leading research, embedding research, co-production, service users and carers
Link Reference: 657
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Patient Research Ambassador Initiative
Type: Website resources
Author: Patient Research Ambassador Initiative hosted by the NIHR
Keywords: Patient Research Ambassador, promoting research
Link Reference: 216
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Patient Research Ambassador Initiative
Type: Website resources
Author: NIHR
Keywords: Patient Research Ambassador, promoting research, PPI
Additional Detail: Includes resources for Trusts
Link Reference: 266
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Peer review
Type: Website resources
Author: NOCLOR
Keywords: peer review, sponsor responsibilities, quality research
Link Reference: 446
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Peer review & the role of RECS.
Type: Policy
Author: Health Research Authority
Keywords: peer review, sponsor responsibilities, quality research, REC review
Link Reference: 445
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People performance management toolkit
Type: Toolkit
Author: NHS Employers
Keywords: People performance management
Link Reference: 421
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Performance in Initiating & Delivery research
Type: Guidance
Author: NIHRCCF
Keywords: Performance metrics
Link Reference: 426
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Performance in Initiating & Delivery research
Type: Slide set
Author: Champions for research support
Keywords: Performance metrics,
Link Reference: 427
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Perspectives on enhancing consent and recruitment in intensive care studies
Type: Video
Author: University of Liverpool
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, consent, intensive care, delivery, informed consent, ICU
Link Reference: 2880
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Pharmacy Assurance
Type: LINK
Author: Health Research Authority
Keywords: pharmacy, HRA, health, research, authority, CTIMP, capacity, capability, review, technical, assessment, form, registered, reviewer, pharmacist, technician, trial, IRAS, protocol, Investigator’s Brochure, IB, SmPC, manual, MHRA, fees,
Link Reference: 763
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Pharmacy Checklist & list of SOPS
Type: Example SOP
Author: York Hospitals NHS Trust
Keywords: Pharmacy, SOPs
Link Reference: 448
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Pharmacy GCP checklist
Type: Example checklist
Author: Dr Stuart McCully
Keywords: Pharmacy, GCP compliance
Additional Detail: Please note that GCP training is not required every 2 years in all Trusts for all Phamacy staff. See the MHRA/HRA statement about this.
Link Reference: 447
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pHINDER
Type: Website resources
Author: NIHR public health research programme
Keywords: adding value, embedding research, growing research, relevant research, public health research, interventions,
Link Reference: 667
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Podcast on the use of electronic consent in clinical trials with Clive Collett (HRA) and Jenny Martin (MHRA)
Type: Website resources
Author: NIHR
Keywords: consent, e-consent, electronic consent, clinical trials, GCP, e-systems, compliance, validated systems
Additional Detail: A really helpful podcast outlining requirements for e-consent and e-consent systems
Link Reference: 753
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Podcast: The impact of PPIE and PPIE in Impact.
Type: Bright Talk
Author: Impact frameworks cultural change conference: Mark Taylor, Trish Greenhalgh, Chris Carrigon.
Keywords: PPI, PPIE, Impact, involvement, inclusion
Link Reference: 10666
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Policy for the management of ETCS
Type: Example Policy
Author: North Bristol NHS Trust
Keywords: Excess Treatment Costs, ETCs, costings
Link Reference: 168
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Policy framework for health & care research
Type: Policy
Author: HRA
Keywords: Policy, HRA
Link Reference: 249
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Policy on Intellectual Property
Type: Example Policy
Author: Leeds Teaching Hospitals NHS Foundation Trust
Keywords: Intellectual Property, IP, Policy
Link Reference: 172
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Portsmouth Hospitals NHS Foundation Trust Research & Innovation Strategy
Type: Example Strategy document
Author: Portsmouth Hospitals NHS Trust
Keywords: Research Strategy,
Link Reference: 514
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Positioning statement – on site Monitoring during COVID-19
Type: Example Guidance
Author: Royal National Orthopaedic Hospital
Keywords: Monitoring, COVID-19, external visitors, monitors, code of conduct, on-site monitoring
Link Reference: 2891
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PPI cost calculator
Type: Tool
Author: NIHR – INVOLVE
Keywords: PPI, costings
Link Reference: 163
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PPI in surgical trials: Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences
Type: Article
Author: Crocker et al; Trials volume 20, Article number: 119 (2019)
Keywords: PPI, surgical trials, design, clinical trials, Sponsorship
Link Reference: 779
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Practical guide to improving gender equality in research organisations
Type: Guide
Author: Science Europe:
Keywords: Gender equality, gender, diversity, embedding research, strategy, leading research, systems, bias
Link Reference: 733
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Preparation for the implementation of the General Data Protection Regulation (GDPR): GDPR, Consent in Research and Confidentiality
Type: Guidance
Author: Medical Research Council
Keywords: GDPR, information governance, data protection, data regulation, consent in research
Additional Detail: Guidance Note 3
Link Reference: 609
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Preparation of a Study Specific Randomisation, Blinding and Code Break Standard Operating Procedure
Type: Example SOP
Author: University College London
Keywords: Randomisation, blinding, code break, SOP
Link Reference: 353
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Preparation, Review and Approval of Study Documents
Type: Example SOP
Author: Nottingham University Hospitals NHS Trust.
Keywords: Study Documents, Protocol
Link Reference: 400
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Preparing a statistical analysis plan
Type: Example SOP
Author: York Foundation Trust
Keywords: statistical analysis
Link Reference: 368
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Principle of consent: children and young people
Type: Website resources
Author: HRA and MRC
Keywords: consent, children, minors
Link Reference: 314
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Procedure for dealing with expressions of interest, feasibility, capability and site selection process for research to be conducted within a speciality or clinical management group at UHL
Type: Example SOP
Author: University of Leicester, University of Loughborough & University Hospitals of Leicester NHS Trust Joint Research Office
Keywords: Expressions of interest, feasibility, site selection, capacity and capability, SOP
Link Reference: 366
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Production, review and approval of SOPS.
Type: Example SOP
Author: Royal Free Hospitals NHS Foundation Trust
Keywords: SOP
Link Reference: 449
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Progress & Safety Reporting
Type: Guidance
Author: Health Research Authority
Keywords: Safety, Reporting, CTIMPs, non-CTIMPs, HRA, REC, Progress reports
Link Reference: 302
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Proportionate Consent
Type: Guidance
Author: HRA
Keywords: consent
Link Reference: 272
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Protection by Exclusion? Capacity as a Gatekeeper to Research
Type: Blog
Author: Victoria Shepherd, Richard Griffith, Mark Sheehan, Fiona Wood, Kerenza Hood
Keywords: mental incapacity, mental capacity, consent, exclusion, access, protection
Link Reference: 637
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Protocol Deviation Reporting: Cutting Through The Ambiguity
Type: Article
Author: Catherine Stewart, clinical sciences group lead, Pfizer, and Laura Galuchie, TransCelerate program lead, Merck
Keywords: protocol deviations, monitoring, integrity, safety, data, oversight, Sponsorship, GCP, ICH
Link Reference: 2830
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Protocol deviation tracking log
Type: Example Form
Author: University of Leicester, University of Loughborough & University Hospitals of Leicester NHS Trust Joint Research Office
Keywords: Protocol, deviation, log
Link Reference: 289
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Protocol Deviations Toolkit
Type: Website resources
Author: Transcelerate
Keywords: protocol deviations, monitoring, integrity, safety, data, oversight, Sponsorship, GCP, ICH
Link Reference: 2819
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Protocol deviations, non compliance and serious breaches
Type: Example SOP
Author: NOCLOR Research Support
Keywords: Protocol, deviation, breach, serious breach, non compliance
Link Reference: 292
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Protocol templates for all research types
Type: Website resources
Author: HRA
Keywords: Protocol
Link Reference: 401
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Public Involvement Standards Development
Type: Website resources
Author: Health & Care Research Wales & the NIHR
Keywords: Public Involvement, Quality, PPI
Link Reference: 267
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Q Initiative
Type: Website resources
Author: Health Foundation
Keywords: Quality
Link Reference: 229
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Q&A on the impact of COVID-19 on research funded or supported by NIHR
Type: Guidance
Author: NIHR/DHSC
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, funding, NIHR research, pause
Link Reference: 2863
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Q&A: Changes to the way Excess Treatment Costs are Paid
Type: Guidance
Author: Association of Medical Research Charities (AMRC)
Keywords: ETCs, Excess Treatment Costs, Funding research, AcoRD, costings, finance, financial management,
Link Reference: 679
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QI Made Simple
Type: Guide
Author: Health Foundation
Keywords: QI, Quality Improvement, research, service evaluation, research definitions, systems, embedding, impact , strategy
Link Reference: 2893
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Quality Assurance Audits
Type: Example SOP
Author: Cambridge University Hospitals NHS Foundation Trust
Keywords: quality, assurance, audit, SOP, Cambridge
Link Reference: 490
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Quality Control & Quality Assurance
Type: Example SOP
Author: Norfolk and Norwich University Hospitals NHS Foundation Trust
Keywords: Quality, SOP
Link Reference: 492
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Quality Systems Workbook
Type: Tool
Author: Research Quality Asscociation
Keywords: Quality
Link Reference: 458
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Questions & Answers: Mental Capacity Act 2005
Type: Website resources
Author: HRA
Keywords: capacity, Mental capacity Act, consultees, consent
Link Reference: 274
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R&D Functions Wheel
Type: Infographic
Author: NHS R&D Forum
Keywords: Research Management
Link Reference: 237
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Radiation Assurance
Type: LINK
Author: Health Research Authority
Keywords: Ionising, Radiation, HRA, Health, Research, Authority, MPE, Medical Physics Expert, CRE, Clinical, ARSAC, exposure, IRAS, review, reviewer, commercial, non-commercial, fees, Part B Section 3, risk statements, radiotherapy, radiology, nuclear medicine, scan, x-ray, CT, PET, SPECT, DEXA, amendments,
Link Reference: 762
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Randomisation & Blinding
Type: Example SOP
Author: Cambridge University Hospitals NHS Foundation Trust
Keywords: blinded randomisation, randomisation, blinding
Link Reference: 236
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Randomisation & Blinding Procedures
Type: Example SOP
Author: University of Leicester, University of Loughborough & University Hospitals of Leicester NHS Trust Joint Research Office
Keywords: Randomisation, blinding, SOP
Link Reference: 354
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Randomisation and code breaking SOP
Type: Example SOP
Author: Newcastle Joint Research Office
Keywords: randomisation, blinding, codebreak, SOP, Sponsorship
Link Reference: 352
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RCP Event: Embedding Research in NHS Trusts: The Alderhey Experience
Type: Slide set
Author: Louise Shepherd
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2823
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RCP Slides: Introduction to How to embed research in NHS trusts to improve patient care
Type: Slide set
Author: Royal College of Physicians Professor Cheng Hok Toh
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2821
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Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials
Type: Paper
Author: Heads of Medicines Agencies Clinical Trial Facilitation Group
Keywords: CTIMPS, complex clinical trials, adaptive trials, protocols, safety, integrity, reporting, complex design, initiation, delivery, conduct, Sponsorship, sponsors, trial design, study set up,
Link Reference: 746
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Recommendations for minimum elements for a clinical trial protocol
Type: Website resources
Author: SPIRIT Group
Keywords: Protocol, Interventional Trials
Link Reference: 403
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REDA Research Manager
Type: Website resources
Author: REDA
Keywords: REDA, Infonetica, system, LPMS, research management
Link Reference: 433
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Reference Safety Information
Type: Blog
Author: MHRA
Keywords: MHRA, reference, safety, IB, SMPC, trial, RSI
Link Reference: 308
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References for evidencing how being research-active improves patient outcomes (October 2018)
Type: Tool
Author: NHS R&D Forum
Keywords: embedding research, research and care, references, quality care, CQC
Link Reference: 685
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Regenerative Medicine
Type: Website resources
Author: HRA
Keywords: HRA, regenerative, regulator
Link Reference: 335
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Registry of Research Data Repositories
Type: Website resources
Author: Datacite
Keywords: transparency, data sharing, data sharing platforms reproducibility, quality, integrity, responsible research, discoverability
Link Reference: 793
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Regulation & Governance of Health Research 5 years on (2016)
Type: Report
Author: Academy of Medical Sciences
Keywords: regulation, governance, report, Academy, Cancer, Wellcome, workshop
Link Reference: 252
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Regulatory Green Light
Type: Example SOP
Author: Newcastle Joint Research Office
Keywords: Regulatory green light, study initiation, study set up, Sponsorship, CTIMPS, GCP
Link Reference: 309
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Reimagine Research Culture Festival
Type: Website resources
Author: Wellcome Trust
Keywords: research culture, inclusion, leadership, strategy, teamscience, equality and diversity,
Additional Detail: The website contains links to pre-recordings and articles
Link Reference: 13633
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Reimagining the R&D role: making the shift from the operational to the strategic
Type: Slide set
Author: David Birch, Ashridge Consultant
Keywords: 
Additional Detail: Ashridge, management, strategy
Link Reference: 238
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Reseach toolkit
Type: Website resources
Author: University of Washington
Keywords: Research proposal, collaboration, start-up
Link Reference: 377
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RESEARCH ACTIVITY INVOLVING PATIENTS WITH CONFIRMED OR SUSPECTED COVID-19
Type: Example SOP
Author: University Hospitals Bristol and Weston
Keywords: SOP, COVID19, research delivery, consent, medical notes, interaction COVID positive
Link Reference: 2904
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Research adrenaline junkie: how clinical research energised my carer
Type: Slide set
Author: RCP/Dr Matthew Brookes, consultant gastroenterologist at the Royal Wolverhampton NHS Trust
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2828
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Research and Development Governance and Performance Report to Trust
Type: Example Report
Author: Oxford University Hospitals NHS Trust
Keywords: report, annual, performance
Additional Detail: 2017
Link Reference: 424
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Research and Evidence Team Annual Review 2017-2018
Type: Example Report
Author: Bristol, North Somerset and South Gloucester CCG
Keywords: Annual report, board reporting, promoting, embedding, influence, impact, communication, R&D office roles, evidence and CCGs
Link Reference: 674
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Research and impaired mental capacity in adults: guidance for researchers
Type: Guidance
Author: Health & Care Research Wales
Keywords: consent, mental incapacity, impaired mental capacity, adults, capacity to consent
Link Reference: 638
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Research and Innovation Hub for clinicians
Type: Toolkit
Author: Royal College of Physicians
Keywords: doctors, physicians, clinical staff, resources, training, support, tools
Link Reference: 3637
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Research but not as we know it. Novel Methods Research Symposium Slide Set. March 2020
Type: Slide set
Author: NHS R&D Forum – multiple authors
Keywords: CIDS, novel methods, innovative trial design, platform studies, RCTS, COVID-19, COVID19, adaptive trial designs
Link Reference: 2861
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Research Contracts & Vendor Selection
Type: Example SOP
Author: North Bristol NHS Trust
Keywords: Sponsorship, Contracts, Vendor, SOP, CTIMP
Link Reference: 399
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Research delivery funding recovery policy
Type: Example Policy
Author: North Bristol NHS Trust
Keywords: CRN funding, financial management, research delivery
Link Reference: 408
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Research Design Service
Type: Website resources
Author: NIHR
Keywords: RDS, Grant Application, Study Support
Link Reference: 379
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Research Design Service
Type: Website resources
Author: NIHR
Keywords: design, support, statisics, NHS, researcher,
Link Reference: 395
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Research Engagement Programme for Allied Health Professionals
Type: Website resources
Author: Tracey Pratchett, Library Services Manager, Lancashire Teaching Hospitals NHS Foundation Trust
Keywords: Library and knowledge services, research skills, creating evidence, developing knowledge
Additional Detail: NHS Library and Knowledge Services and Research and Innovation work together to encourage ‘home-grown’ research in an acute Trust
Link Reference: 675
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Research Ethics Library
Type: Website resources
Author: Norwegian National Library
Keywords: Ethics
Additional Detail: NB: This is a Norwegian tool but very comprehensive
Link Reference: 391
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Research ethics, publication ethics and good practice guidelines
Type: Website resources
Author: EQUATOR Network
Keywords: Ethics, Grant, Academic
Link Reference: 390
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Research for all
Type: Report
Author: Royal College of Physicians
Keywords: Engagement, barriers
Link Reference: 226
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Research for all: Sharing good practice in research management in partnership with the NHS R&D Forum
Type: Paper
Author: Royal College of Physicians & NHS R&D Forum
Keywords: Research medical, academic medicine Reearch, Researcher, Academic
Link Reference: 190
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Research for All: University of Southampton NHS Foundation Trust Research Strategy: Executive Summary
Type: Example Strategy
Author: University Hospitals Southampton NHS Foundation Trust
Keywords: strategy, research strategy, research for all
Link Reference: 621
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Research funding scheme
Type: Example Scheme
Author: Leicester Partnership NHS Trust
Keywords: Research funding scheme, application form
Link Reference: 183
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Research funding scheme
Type: Example Scheme
Author: Oxfordshire Health Services Research Committee
Keywords: Small grant funding , charitable research funds
Additional Detail: A grant funding scheme run on charitable funds
Link Reference: 184
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Research Governance Framework for Health & Social Care (2005)
Type: Policy
Author: Dept. Health
Keywords: research governance, RGF, health research systems
Additional Detail: To be replaced by the UK Health Research Policy Framework for Health & Social Care http://www.hra.nhs.uk/resources/research-legislation-and-governance/research-governance-frameworks/
Link Reference: 254
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Research indemnity & GP practices advice sheet (2017)
Type: Example Tool
Author: Nottingham City CCG
Keywords: Indemnity, GP, Primary Care
Link Reference: 442
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Research Integrity Concordat- Universities UK
Type: Policy
Author: University UK Consortium
Keywords: Research integrity, integrity, concordat, quality, RRI
Link Reference: 348
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Research Management Guide for Medical Research Charities
Type: Guide
Author: Association Medical Research Charities (AMRC)
Keywords: research management, charities,
Additional Detail: For medical research charities but also useful for other health & care research management teams
Link Reference: 633
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Research Participant Home Visits: Code of Conduct
Type: Example
Author: Cambridge University Hospitals NHS Trust/ Cambridge BRC
Keywords: Home visits, participants home visits, COVID-19, COVID, home, research,
Link Reference: 2888
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Research Passports
Type: Website resources
Author: NIHR
Keywords: research; NHS; contract; passport
Link Reference: 170
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Research Practitioner Framework
Type: Example
Author: CAHPR
Keywords: competency framework, clinical research, research, knowledge, skills, clinical academics, AHPs, Research practiioners
Link Reference: 2848
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Research Registry
Type: Website resources
Author: IJS Publishing Group
Keywords: Research register,
Additional Detail: A register for all types of research from first in man, observational, systematic review and meta-analysis research
Link Reference: 464
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Research Safety Reporting
Type: Example SOP
Author: University Hospital Bristol NHS Foundation Trust
Keywords: Safety, SAE, AE, SUSAR, Sponsorship, DSUR
Link Reference: 307
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Research Strategy, Enhancing patient experience and outcomes through research opportunity and innovation for all patients and all staff
Type: Example Strategy
Author: East and North Hertfordshire NHS Trust
Keywords: 
Link Reference: 784
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Research Study Amendments
Type: Example SOP
Author: North Bristol NHS Trust
Keywords: Amendments, Sponsorship, Approval, SOP
Link Reference: 572
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Research Support Service Framework documents
Type: Guidance
Author: Developed with DH RSS Champions (Now HRA RSS Champions)
Keywords: template, SOP,
Link Reference: 455
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Research Tissue Banks – E-learning
Type: Training Course
Author: Human Tissue Authority & Health Research Authority
Keywords: Tissue bank, biobank, repository, governance, regulatory compliance, REC approval,
Additional Detail: These modules are accessible in the HRA learning management platform
Link Reference: 2840
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Research Tissue Banks FAQs
Type: Guidance
Author: Human Tissue Authority (HTA)
Keywords: Tissue bank, biobank, repository, governance, regulatory compliance, REC approval,
Link Reference: 771
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Research to publication: BMJ training modules
Type: Website resources
Author: BMJ
Keywords: Training, Publication, Research Skills
Link Reference: 205
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Research Waste and Ensuring Transparency
Type: Blog
Author: Juliet Tizzard, Health Research Authority
Keywords: research waste, transparency, adding value, integrity, evidence
Link Reference: 655
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Research waste is still a scandal—an essay by Paul Glasziou and Iain Chalmers
Type: Paper
Author: Paul Glasziou and Iain Chalmers
Keywords: research waste, transparency, adding value, integrity, evidence
Link Reference: 702
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Research, evaluation and evidence: a guide for CCGs commissioners
Type: Guidance
Author: Bath R&D Unit
Keywords: Funding, guidance; commissioning
Additional Detail: Supporting a duty to promote
Link Reference: 217
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Research, GDPR and confidentiality – what you really need to know.
Type: Training Course
Author: MRC Regulatory Support Centre
Keywords: GDPR, data protection, information governance, data protection legislation, data protection act, general data protection regulation
Additional Detail: e-learning
Link Reference: 673
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Researchers, managers, commissioners lend me your ears
Type: Slide set
Author: West of England, Avon Primary Care Research Collaborative
Keywords: commission, manage, interdependence, evaluation, improvement, workshop, West of England, collaborative
Link Reference: 228
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Responsible research toolkit
Type: Website resources
Author: Responsible Research
Keywords: Responsible Research, Innovation, Public Engagement
Link Reference: 349
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Review of Research Including Peer Review and Departmental Authorisation
Type: Example SOP
Author: Barts Health NHS Trust & Queen Mary University of London
Keywords: Sponsorship, Sponsor process, peer review
Link Reference: 476
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Reviewing Peer Review
Type: Website resources
Author: Andy Clempson and AMRC
Keywords: Peer review, Sponsorship, Funding, peer review process, improving peer review
Link Reference: 783
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Reward alliance
Type: Website resources
Author: Reward Alliance
Keywords: Protocol Design, Waste, Research Question
Link Reference: 484
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Risk Adaption in Clinical Trials of CTIMPS
Type: Blog
Author: MHRA
Keywords: risk, risk adaption, CTIMPS, MHRA, risk assessment.
Additional Detail: This blog is about risk adaption in CTIMPS, which includes risk assessment.
Link Reference: 346
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Risk Assessment SOP
Type: Example SOP
Author: University Hospitals Leicester NHS Trust
Keywords: SOP Research sponsor risk assessment mitigation plan
Link Reference: 469
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Risk Assessment SOP for ATIMPS
Type: Example SOP
Author: Newcastle Joint Research Office
Keywords: Standard operating procedure, SOP, Clinical Trial Risk Assessment
Link Reference: 472
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Risk Assessment. Sponsored Research
Type: Example SOP
Author: NOCLOR Research Support
Keywords: Standardised Operating Procedure, SOP, Sponsor Research, Risk Assessment.
Link Reference: 474
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Risk Assessments for CTIMPS
Type: Example risk assessment
Author: MHRA GCP Forum
Keywords: MHRA, risk assessment, forum, example
Link Reference: 468
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Risk based monitoring initiative assets
Type: Website resources
Author: Transcelerate
Keywords: risk based monitoring, planning, assessments.
Link Reference: 471
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Role of Chief Investigators
Type: Guidance
Author: HRA
Keywords: Chief Investigator, Role and Responsibility
Link Reference: 188
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Roles of a Sponsor
Type: Website resources
Author: Health Research Authority
Keywords: Sponsor responsibility, CTIMP
Link Reference: 478
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Safety Training Slides
Type: Slide set
Author: Transcelerate
Keywords: transcelerate, safety, training, resources, qualification
Link Reference: 306
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Sail data bank
Type: Website resources
Author: Sail data bank University of Swansea
Keywords: transparency, data sharing, data sharing platforms reproducibility, quality, integrity, responsible research, trusted research environmnet
Link Reference: 796
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Schedule of Events Cost Attribution Template (SoECAT) guidance
Type: Guidance
Author: DHSC non commercial costings group
Keywords: AcoRD, costing, cost attribution, FAQs, SoECAT
Link Reference: 2833
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School for Change Agents: Module 1: Change starts with me
Type: Slide set
Author: School for Change Agents
Keywords: 
Link Reference: 601
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Scientific archivists group- excellence in records management and archives
Type: Website resources
Author: Scientific archivists group
Keywords: records, archive, records management, archiving
Additional Detail: Website with links to
Link Reference: 489
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Seeing theory: A visual introduction to probability and statistics
Type: Toolkit
Author: Daniel Kunin
Keywords: statistics, research design, probability, understanding stats
Link Reference: 603
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Serious Breach tracker sheet for the R&D Office
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: Serious breach, GCP, breach, incident, tracker, safety
Link Reference: 571
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SHARE NHS Research Scotland register of individuals interested in participating in research
Type: Website resources
Author: Chief Scientist Office Scotland
Keywords: Research register, Scotland, res
Link Reference: 385
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Simon Denegri۪s patient and public involvement updates
Type: Blog
Author: Simon Denegri
Keywords: patient involvement, public involvement, PPI
Link Reference: 265
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Simple Guide to the NHS
Type: Guidance
Author: NHS England
Keywords: NHS, Structure,
Link Reference: 241
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Social Media Strategy
Type: Website resources
Author: Fast Track Impact
Keywords: Template Social Media Strategy
Link Reference: 149
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Social Media Toolkit
Type: Toolkit
Author: NIHR CRN: Accelerating Digital
Keywords: Communications, Social Media, SoMe, Twitter, tools, toolkit
Link Reference: 648
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Social Media Toolkit for the NHS
Type: Website resources
Author: NHS Employers
Keywords: Social Media
Link Reference: 153
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Solent Academy of Research & Improvement
Type: Example Video
Author: Solent NHS Trust
Keywords: Role of R&D, R&I services, research and improvement, researcher services, R&D, animation
Link Reference: 2900
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Solent Research Care Home Partnership
Type: Example Leaflet
Author: Solent NHS Trust
Keywords: Promoting research, research partnership
Link Reference: 524
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Solent Research Care Home Partnership
Type: Example Video
Author: Solent NHS Trust
Keywords: Solent, research, care home, video
Link Reference: 525
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Solent research conference
Type: Example conference
Author: Solent NHS Trust
Keywords: Conference, research promotion
Additional Detail: Example past research conference
Link Reference: 148
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SOP – Obtaining informed consent for clinical trials
Type: Example SOP
Author: Kings Health Partners
Keywords: consent, SOP
Link Reference: 275
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SOP for applying to external orgainsations for funding where UHL is the lead organisation
Type: Example SOP
Author: University of Leicester, University of Loughborough & University Hospitals of Leicester NHS Trust Joint Research Office
Keywords: SOP, applying, funding, Leicester,
Link Reference: 356
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SOP for Archiving Essential Documentation relating to CTIMPS
Type: Example SOP
Author: UCL Joint Research Office but Out of date?
Keywords: Archiving, Essential Documents, CTIMPS
Link Reference: 487
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SOP for Developing a research protocol
Type: Example SOP
Author: Norfolk & Norwich University Hospitals NHS Foundation Trust
Keywords: Protocol, SOP
Link Reference: 402
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SOP for drug preparation, vaccination procedures (including management of anaphylaxis) and waste management for the following study: A phase II/III study to determine the efficacy, safety and immunogenicity of the candidate coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 (COV002).
Type: Example SOP
Author: Sheffield Teaching Hospitals NHS Foundation Trust
Keywords: Study specific SOP, Vaccine studies, Vaccines, SOP
Link Reference: 2903
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SOP for identifying and reporting deviations & serious breaches of GCP and/or the protocol for research where UHL is the host organisation or site
Type: Example SOP
Author: University of Leicester, University of Loughborough & University Hospitals of Leicester NHS Trust Joint Research Office
Keywords: deviations, breaches, GCP
Link Reference: 288
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SOP for process to open or reopen non-pandemic research conducted within University Hospitals of Leicester NHS Trust (UHL) during a pandemic.
Type: Example SOP
Author: University of Leicester & University Hospitals of Leicester Joint Research Support Office
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, re-open, open studies, SOP
Link Reference: 2870
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SOP for Registering and Reporting Research in a Publicly Accessible Database
Type: Example SOP
Author: NHS Tayside and the University of Dundee
Keywords: Transparency, reporting, registration, regulatory compliance, CTIMPS, Sponsorship
Link Reference: 688
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SOP for reporting serious breaches in clinical research
Type: Example SOP
Author: Portsmouth Hospitals NHS Trust
Keywords: Serious breach, incident
Link Reference: 291
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SOP for the management of suspected fraud and misconduct in research where UHL is the host organisation or research site
Type: Example SOP
Author: University Hospitals Leicester NHS Trust
Keywords: Fraud, misconduct, SOP
Link Reference: 347
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SOP: Remote Monitoring
Type: Example SOP
Author: Nottingham University Hospitals NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, remote monitoring
Additional Detail: Please note this is a DRAFT SOP at the time of publication
Link Reference: 2871
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SOPs for Research Ethics Committees
Type: SOP Template
Author: Health Research Authority
Keywords: SOPS, RECS, Research ethics
Link Reference: 342
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Sponsor agreement. Division of Sponsorship responsibilities matrix
Type: Example agreement
Author: Portsmouth Hospitals NHS Trust
Keywords: Sponsorship, Sponsorship responsibilities, delegation
Additional Detail: Template to clarify sponsor responsibilities
Link Reference: 481
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Sponsor Decision Tree for Excess Treatment Costs
Type: Tool
Author: NIHR
Keywords: ETCs, Excess Treatment Costs, payment models
Link Reference: 10662
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Sponsor fees: Meeting the cost for non-commercial research Survey results
Type: Guidance
Author: NHS R&D Forum
Keywords: Sponsorship, Sponsor fees, finance
Additional Detail: Please be aware this document dates from 2010
Link Reference: 482
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Sponsor Monitoring guidelines:
Type: Example Guidance
Author: Royal Free London NHS Foundation Trust
Keywords: Monitoring, audit, code, remote access, COVID-19, COVID, Sponsorship, Sponsors
Link Reference: 3630
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Sponsor oversight, blog 2
Type: Blog
Author: MHRA
Keywords: Sponsorship, Sponsor, oversight, audit, monitoring, quality, risk, sponsors, regulation, GCP, clinical trials, CTIMPS
Link Reference: 695
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Sponsor review checklist
Type: Example Form
Author: University Hospitals Leicester NHS Trust
Keywords: Sponsor checklist
Additional Detail: Example sponsor review checklist
Link Reference: 479
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Sponsor Risk assessment areas
Type: Example risk assessment
Author: The Christie NHS Foundation Trust:
Keywords: Sponsorship, set up, process, Sponsors, sponsor process, risk, risk assessment
Additional Detail: This is supporting information to go with the Non commercial Sponsors symposium Slideset Nov 2019
Link Reference: 799
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Sponsored studies site capability form
Type: Example Form
Author: Newcastle upon Tyne NHS Foundation Trust
Keywords: Sponsorship, site, capability, oversight, capacity
Link Reference: 112
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Sponsorship and Confirmation of Capacity and Capability of COVID-19 Studies [PDF 331KB]
Type: Example SOP
Author: Joint Research Management Office, Queen Mary University of London and Barts Health NHS Trust
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent
Additional Detail: Please note the date of publication and that all may be updated over time
Link Reference: 2852
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Sponsorship of an international project
Type: Example Policy
Author: Cambridge University Hospitals NHS Foundation Trust
Keywords: sponsor, sponsorship, international, Cambridge
Link Reference: 477
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Sponsorship Principles
Type: Guidance
Author: NHS R&D Forum, updated by Tanya Symons (T Symons Associates), June 2016
Keywords: Sponsorship, oversight, GCP, legal representative, co-sponsor, joint sponsor, research governance
Link Reference: 410
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Sponsorship risk assessment
Type: Example risk assessment
Author: North Bristol NHS Trust
Keywords: Sponsorship, set up, process, Sponsors, sponsor process, risk, risk assessment
Link Reference: 691
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Standard Operating Procedure for Preparation & Procedure to Archive
Type: SOP Template
Author: Portsmouth Hospitals
Keywords: Archiving, close out, end of study, SOPs, Sponsorship, host site
Link Reference: 486
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Standard Operating Procedure for Qualitative Components of Trials & other Rigorous Studies in Health & Social Care
Type: Example SOP
Author: West Wales Organisation for Rigourous Trials in Health
Keywords: SOP, Wales, Qualitative, rigorous, trials
Link Reference: 404
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Standard Operating Procedures (SOPs): Production, approval and review
Type: Example SOP
Author: Papworth Hospital NHS Foundation Trust
Keywords: SOP, SOP production, SOP approval, SOP review
Additional Detail: Example system for SOP production, approval and review
Link Reference: 457
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Statistical Analysis Plans
Type: Guidance
Author: European Network of Centres for Pharmacoepidemiology & Pharmacovigilence
Keywords: Methodological Standards, Pharmacoepidemiology
Link Reference: 387
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Statistical Analysis Plans for Clinical Trials
Type: Example SOP
Author: NHS Grampian and the University of Aberdeen
Keywords: Statistical analysis, SOP
Link Reference: 369
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Statistical disclosure control – anonymisation checker
Type: Guide
Author: Readthedocs
Keywords: transparency, data sharing, content anonymisation, reproducibility, quality, integrity, responsible research,
Link Reference: 795
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Step by step guide on twitter to help the blind and partially sighted to hear your images on Twitter
Type: Guide
Author: NHS Digital
Keywords: social media, twitter, partially sighted, communications, blind, visually impaired, images
Additional Detail: This guide is step by step in a twitter thread.
Link Reference: 591
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Stop Motion Animations & Filming
Type: Example workshops
Author: North West R&D
Keywords: Stop motion, filming, communications, engagement
Link Reference: 147
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Study and site initiation report
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: Sponsorship, site, capability, oversight, capacity, initiation,
Link Reference: 53
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Study breach record and reporting form
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: study, breach, serous, deviation, record, report
Link Reference: 290
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Study Design Considerations for Clinical Trials
Type: Guidance
Author: Health Research Authority
Keywords: HRA, study, design, clinical, researcher, sponsor, funder, peer
Link Reference: 393
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Study Participant Feedback Questionnaire (SPFQ) Toolkit
Type: Toolkit
Author: Transcelerate
Keywords: Patient participation, transparency, Sponsorship, set up, feedback, oversight, process, Sponsors, sponsor process, project design
Link Reference: 782
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Study/Trial Master File Structure
Type: Example Form
Author: NOCLOR Research Support
Keywords: Study/Trial Master File Template
Link Reference: 298
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Studyline
Type: Website resources
Author: Oxford University Hospitals NHS Trust
Keywords: Portfolio management system
Link Reference: 430
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Suite of SOPS
Type: Example SOP
Author: Keele University
Keywords: Sponsorship, quality management, QA, SOPS, Primary Care, processes, Sponsors, sponsor process, delegation of responsibilities, delegation of duties, roles, agreements, oversight
Link Reference: 739
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Summary information research involving adults who lack capacity to consent
Type: Leaflet
Author: Victoria Shepherd, NIHR Doctoral Research Fellow at Cardiff University
Keywords: 
Link Reference: 635
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Summary of the UK Policy Framework for GPs
Type: Guide
Author: NHS South Norfolk CCG R&D Office
Keywords: UK Policy Framework; GP
Link Reference: 589
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Summary of UK Policy Framework for Healthcare Organisations
Type: Guide
Author: NHS South Norfolk CCG
Keywords: UK Policy Framework
Link Reference: 590
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Summary Report: Medical & Dental Pay Scales for Junior Doctors.
Type: Example
Author: Mark Terry: The Royal Marsden NHS Foundation Trust
Keywords: Pay scales, clinical research fellows, clinical research staff, finance, funding
Link Reference: 2820
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Supporting Grass Roots Innovation
Type: Article
Author: Philip Smith, East and North Hertfordshire NHS Trust
Keywords: innovation, growth, resources, champions, ideas, innovation ready
Link Reference: 2889
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Supporting Health & Social Care Research
Type: Website resources
Author: NIHR CRN
Keywords: Embedding, staff, promoting research, enabling research, research culture
Link Reference: 649
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Supporting Research in the NHS: Excess Treatment Costs Animation
Type: Video
Author: NIHR CRN
Keywords: ETCs, Excess Treatment Costs, Funding research, AcoRD, costings, finance, financial management,
Link Reference: 680
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Sustainability & transformation plans
Type: Website resources
Author: NHSE
Keywords: NHS England, sustainability, transformation, future, partnership
Link Reference: 244
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Sustainability & transformation plans
Type: Website resources
Author: Kingsfund
Keywords: STP, sustainability and transformation plans ,
Link Reference: 245
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SWATS: Studies within a Trial
Type: Video
Author: NIHR HTA Programme Director: Hywel Williams
Keywords: SWAT, clinical trials, study within a trial, funding, applications, grant, design
Link Reference: 663
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SYNAPSE: Synergising Patient Engagement
Type: Website resources
Author: Patient Focused Medicines Development
Keywords: PPI, PPIE, Patient engagement, patient involvement, PPI pledge,
Additional Detail: Patient engagement initiatives, organizations, experts from around the world in one place
Link Reference: 599
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Teaching Tips – Teaching randomisation
Type: Website resources
Author: Teachers of evidence based health care:
Keywords: training, teaching, randomisation, RCT, evidence, evidence based health care
Link Reference: 699
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Team science
Type: Website resources
Author: Academy of Medical Sciences
Keywords: Academy, team, science, incentive, disincentive, reward, recognition
Link Reference: 186
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Team science toolkit
Type: Website resources
Author: National Cancer Institute
Keywords: team, science, toolkit, cancer, interactive, resource
Link Reference: 191
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Team Science: Two Year Follow-Up Report
Type: Report
Author: Academy of Medical Sciences
Keywords: Team science, teams, collaboration, partnership, reward, recognition, value, adding value
Link Reference: 737
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The communication continuum before, during and after participating in a clinical study
Type: Infographic
Author: Transcelerate
Keywords: Communication, consent, set up, facilitation, design, clinical trials, delivery, close out
Link Reference: 661
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The Delphi technique: What is it, when is it used, and how is it done?
Type: Blog
Author: Kristen Dufresne for Students 4 best evidence
Keywords: Research design, research methods, delphi technique,
Additional Detail: Helpful blog on this research design
Link Reference: 327
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The Development of a core competency framework for clinical research staff:
Type: Article
Author: Merrie Gowie, Danielle Wilson, Sarah Gregory, Louise L.Clark
Keywords: competency framework, clinical research, research, knowledge, skills
Additional Detail: Competencies for clinical research practitioners
Link Reference: 2841
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The ethical, governance & management implications of involving consumers in health research
Type: Slide set
Author: Virginia Minogue and Anne Laure Donskoy
Keywords: Coapplicancy, co-applicants, PPI, patient and public involvement, consumers, service users and carers, ethics, governance, legal
Link Reference: 2837
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The evidence base for the impact of research activity on quality of care: what we know, what we need to know. A workshop report.
Type: Report
Author: NIHR CRN CC
Keywords: embedding research, research and care, impact of clinical research, research impact, evidence for research
Link Reference: 2883
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The first of its kind, a partnership to deliver clinical trials
Type: Slide set
Author: Northumbria Healthcare NHS Foundation Trust and Synexus Ltd
Keywords: partnership, clinical, trials, Northumbria, Synexus
Link Reference: 522
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The First Year Implementation Of A Research Strategy For East And North Hertfordshire NHS Trust
Type: Article
Author: East and North Hertfordshire NHS Trust
Keywords: Research Strategy Patient Benefit
Link Reference: 786
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The Guide to Efficient Trial Management
Type: Guide
Author: UK Trial Managers Network
Keywords: Trial Managers; research, management;
Link Reference: 311
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The handbook of quality and service improvement tools
Type: Guidance
Author: NHS Institute for innovation & improvement
Keywords: innovation, improvement, handbook, quality, service, tools
Additional Detail: The institute no longer exists but the handbook was still accessible Dec 16
Link Reference: 233
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The literature search process for NHS researchers
Type: Example Guidance
Author: Thames Valley & Wessex HealthCare Librarians
Keywords: Literature searching , PICO
Link Reference: 378
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The national elf service – evidence based practice
Type: Website resources
Author: National Elf Service
Keywords: Evidence based practice, Evidence,
Additional Detail: An evidence based practice resource and community , with opportunities for continuing professional development
Link Reference: 197
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The research ethics guidebook for social scientists
Type: Website resources
Author: University of London
Keywords: Scotland Legislation, Mental Health Capacity, Mental Capacity Act
Link Reference: 350
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The Researcher Magazine
Type: Example magazine
Author: North West R&D
Keywords: Communications, Publications, R&D Magazine
Additional Detail: Created by health researchers for health researchers
Link Reference: 219
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The role of an R&D Office
Type: Guidance
Author: Health Research Authority
Keywords: NHS R&D, NHS Research & Development
Additional Detail: Find out more abou the role of NHS R&D offices
Link Reference: 239
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The role of the UK CRF Network Study Intensity Tool (SIT) in research workforce planning
Type: Slide set
Author: University Hospitals Birmingham NHS Foundation Trust
Keywords: UK CRF Network Study Intensity Tool (SIT), Study complexity, Measurememts
Link Reference: 175
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The Second Year Implementation Of A Research Strategy For East And North Hertfordshire NHS Trust
Type: Example
Author: East and North Hertfordshire NHS Trust
Keywords: Research Strategy Patient Benefit
Link Reference: 787
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The Whitehouse Report: Review of Research Nursing and Midwifery across the UK and Ireland in 2017, structures, strategies and sharing
Type: Report
Author: Claire Whitehouse
Keywords: Building teams, Research team, research delivery, delivery staff, research nurses, AHP, research nurse structures,
Link Reference: 647
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Time for a new direction -a series of blogs on PPI in research
Type: Blog
Author: Kristina Staley
Keywords: PPI, leading research, embedding research, co-production, service users and carers
Link Reference: 700
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Tissue Licensing FAQs
Type: Website resources
Author: Human Tissue Authority
Keywords: HTA FAQ Licencing
Link Reference: 340
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TMF Location Form
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: Study/Trial Master File
Link Reference: 295
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TMF Reference Model
Type: Website resources
Author: A Document & Records Management Community Project
Keywords: TMF, Trial Master File, Filing Structure, Essential Documents
Link Reference: 769
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Toolkit for clinical researchers
Type: Website resources
Author: National toolkit of dental & craniofacial research
Keywords: Overseas Clinical Trials, USA, FDA
Additional Detail: NB: This is an American site
Link Reference: 454
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Top Tips for EudraCT reporting
Type: Infographic
Author: NHS R&D Forum Research Management Working Group
Keywords: clinical trials register, EudraCT, trials registration, end of study summary, results, Transparency, reporting, registration, regulatory compliance, CTIMPS, Sponsorship
Link Reference: 749
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Training requirements for researchers
Type: Guidance
Author: HRA and MHRA
Keywords: Training, Responsibilities
Link Reference: 202
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Training requirements for researchers
Type: Policy
Author: Health Research Authority and stakeholders
Keywords: 
Link Reference: 575
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Training slides for clinical researchers at site
Type: Slide set
Author: Transcelerate & SCRS
Keywords: Clinical Trials, Training Modules
Link Reference: 200
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Transcelerate Patient Protocol Engagement Toolkit (P-PET)
Type: Toolkit
Author: Transcelerate
Keywords: PPI, patient involvement, protocol development, Sponsorship, set up, process, Sponsors, sponsor process, design, adding value, reducing waste, delegation of responsibilities, delegation of duties, roles, agreements, oversight
Link Reference: 781
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Transforming healthcare through clinical academic roles in nursing, midwifery and allied health professions
Type: Guide
Author: Association of UK University Hospitals Trusts (AUKUH)
Keywords: Clinical Academic Careers, pathway, AHPS, Nursing, midwifery
Additional Detail: A practical resource for healthcare provider organisations
Link Reference: 413
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Transparency survey results Dec 2018
Type: Report
Author: Health Research Authority
Keywords: transparency, quality, integrity, study registrations, trials registration
Link Reference: 714
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Transparency: Researchers’ Responsibilities
Type: Guidance
Author: Health Research Authority
Keywords: transparency, quality, integrity, study registrations, trials registration, end of study reports
Link Reference: 734
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Trial closure and end of trial reporting
Type: Example SOP
Author: Papworth Hospital NHS Foundation Trust
Keywords: SOP, End of Trial, Study Closure
Link Reference: 316
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Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
Type: Article
Author: Trial Forge
Keywords: Research design, trial design, study within a trial, SWAT
Additional Detail: Guidance 1
Link Reference: 611
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Trial Forge: A systematic approach to make trials more efficient
Type: Website resources
Author: Trialforge
Keywords: RCT, Randomised Controlled Trials, Methodology
Link Reference: 364
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Trial Managers Task, Knowledge & Competency Framework
Type: Toolkit
Author: UK Trial Managers Network
Keywords: Task, Knowledge and Competency Framework for Trial Managers
Link Reference: 418
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Trial Restart Risk Assessment (randomised control trials (NOT requiring Competent Authority Approval)) – COVID 19. V1.0 28-05-2020.docx
Type: Example risk assessment
Author: Newcastle Joint Research Office
Keywords: COVID-19, COVID19, COVID, advice, guidance, researchers, pandemic, emergency, urgent, restart, risk assessment, non-CTIMPs
Link Reference: 2872
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Trust R&D Incentive Fund
Type: Award scheme
Author: Jane Greenaway
Keywords: small grants, fellowship grants, CI development
Link Reference: 576
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Types of Study
Type: Guidance
Author: Health Research Authority
Keywords: Study Type, Student Research, CTIMP, Tissue Banks
Link Reference: 438
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UHB Sponsored studies Site initiation checklist
Type: Example Form
Author: University Hospital Bristol NHS Foundation Trust
Keywords: Checklist, Sponsor Studies, Site initiation
Link Reference: 310
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UK Clinical Trials Gateway
Type: Website resources
Author: NIHR
Keywords: Clinical Trial database
Link Reference: 386
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UK Local Information Pack
Type: Guidance
Author: Four Nations including HRA
Keywords: site set up, research approvals, regulatory approvals, local capacity & capability, SSI, UK local Information Pack, Organisation information Document
Link Reference: 761
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UK Research ethics committees
Type: Website resources
Author: Health Research Authority
Keywords: HRA, Approvals, Regulation
Link Reference: 341
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UK Research Integrity Office
Type: Website resources
Author: UKRIO
Keywords: Research Integrity, Compliance, Fraud,
Link Reference: 344
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UK Standards for Public Involvement: Implementation Stories (a handbook)
Type: Guidance
Author: Four Nations Partnership
Keywords: PPI, leading research, embedding research, co-production, service users and carers, standards
Link Reference: 2884
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UKCRC Registered CTU Network
Type: Website resources
Author: UKCRC
Keywords: CTU, Clinical Trial Units, UKCRC
Link Reference: 177
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UKCRC Tissue Directory & coordinating centre
Type: Website resources
Author: UKCRC
Keywords: RTB, Research Tissue Bank, BioBank
Link Reference: 195
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UKRIO research Misconduct Investigation Procedure
Type: Policy
Author: UKRIO
Keywords: Research Integrity, Compliance, Fraud, Misconduct
Link Reference: 462
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Understanding HRA Approval
Type: Guide
Author: Health Research Authority
Keywords: HRA approval
Link Reference: 330
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University Hospital Bristol NHS Foundation Trust Research and Innovation Strategy 2014-2019
Type: Example Strategy document
Author: University Hospital Bristol NHS Foundation Trust
Keywords: Research Strategy, Objectivies, Research Vision
Link Reference: 519
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Unleashing Awesomeness through Team Transformation
Type: Slide set
Author: Royal Wolverhampton NHS Trust
Keywords: Team transformation, communication, leadership
Link Reference: 419
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Urgent Safety Measures Reporting Form
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: SOP, Clinical Trial Reporting, Urgent Safety Measures
Link Reference: 305
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Use of Vendors
Type: Example SOP
Author: Cambridge University Hospitals NHS Foundation Trust
Keywords: SOP, Trial Management, Trial Services, Vendors
Link Reference: 398
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Vaccination Trials Model Service Level Agreement for NHS Organisations and University Service Providers 29.09.20
Type: Example agreement
Author: 4 nations contracting group
Keywords: SLA, contract, agreement, vaccine, hub and spoken, university, NHS, service level agreement
Link Reference: 13631
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Vendor GCP sample questions
Type: Example Form
Author: Barts Health NHS Trust & Queen Mary University of London
Keywords: Vendor selection, GCP, Sponsorship
Link Reference: 396
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Vendor Management
Type: Example SOP
Author: Nottingham University Hospitals NHS Trust.
Keywords: SOP, Trial Management, Trial Services, Vendors
Link Reference: 397
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Vendor Pre-qualification questionnaire v1.1
Type: Example Tool
Author: North Bristol NHS Trust
Keywords: Sponsorship, sponsors, oversight, vendor selection, quality systems, vendor assessment
Link Reference: 689
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Verbal Consent (Rec approved script):
Type: Example
Author: Nottingham University Hospitals NHS Trust.
Keywords: consent, verbal consent, COVID-19, research at a distance, clinical research
Link Reference: 2886
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Version Control Document Tracking Checklist
Type: Example Form
Author: York Foundation Trust
Keywords: Version Control, template
Link Reference: 312
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Version Control of Study Documents
Type: Example SOP
Author: Papworth Hospital NHS Foundation Trust
Keywords: Version Control, GCP, SOP
Link Reference: 313
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Videos about clinical trials
Type: Video
Author: Medical Research Council
Keywords: Video, Clinical Trial, Cancer, HIV, Patient and Public Involement
Link Reference: 215
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Virtual and e-consent in Research at NuTH
Type: Example SOP
Author: Newcastle JRO
Keywords: Econsent, E-consent, Virtual consent, remote consent, GCP, Sponsorship, CTIMPS
Link Reference: 5411
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What are the financial benefits of research in the NHS
Type: Video
Author: Pratima Chowdary, professor and consultant of haematology at the Royal Free Haemophilia Centre.
Keywords: embedding research, research and care, staff, staff time, make space, time, research time, CQC, well led
Link Reference: 2829
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What do people think about third parties using NHS data? Foundations of Fairness Report
Type: Report
Author: Under Patient Data
Keywords: trust, patient data, understanding patient data, trustworthiness, information governance
Link Reference: 5550
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What does a great lay summary look like?
Type: Example
Author: The Academy of Medical Sciences
Keywords: lay summary, research ethics, ethical research, protocol, grant writing, summaries, PPI, patient and public involvement, transparency
Link Reference: 2835
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What is Social Media
Type: Guide
Author: NIHR CLAHRC Wessex
Keywords: Social networking, Facebook, Linkedin, Twitter
Link Reference: 151
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What is Social Media – an easy guide
Type: Guidance
Author: CLARCH Wessex
Keywords: Social networking, Facebook, Linkedin, Twitter
Link Reference: 155
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What is your lawful basis?
Type: Video
Author: Medical Research Council
Keywords: GDPR, information governance, data protection, data regulation, lawful basis, consent in research
Link Reference: 639
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Why study registration is important for the future of research
Type: Blog
Author: Dr Matthew Westmore
Keywords: transparency, quality, integrity, study registrations, trials registration
Link Reference: 654
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With the right training people with learning disabilities can become partners in research
Type: 
Author: NIHR
Keywords: involvement, inclusion, equality, diversity, PPI, research partners, training
Link Reference: 2902
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Wonder Women Series
Type: Video
Author: North West R&D
Keywords: research careers, inspiration, women in research, research, embedding, leadership, research leadership
Link Reference: 708
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Writing a communications strategy
Type: Slide set
Author: University of Oxford
Keywords: Communication, communication channels, communication mission
Link Reference: 145
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YouTube Channel for UKCRC Tissue Directory & Coordinating Centre
Type: Video
Author: UKCRC Tissue Directory & Coordinating Centre
Keywords: Tissue banks, biobanks, Tissue directory
Link Reference: 459
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