{"text_format":"1","workbook":"xlsx","n_sheets":5,"sheets":["Study Detail","Risks","Mitigation Plan","HRA checklist","Sheet1"],"not_rendered":{"charts":0,"images":0,"macros":1,"external_links":0,"defined_names":2,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"Study Detail","index":0,"n_rows":76,"n_cols":6,"rows_kept":76,"cut":false,"hidden":false,"merged":[[31,1,31,6],[37,1,37,2],[36,1,36,7],[37,4,37,7],[38,4,41,7],[33,1,33,7],[34,1,34,7],[26,1,26,6],[27,1,27,6],[28,1,28,6],[29,1,29,6],[30,1,30,6],[23,1,23,6],[24,1,24,6],[25,1,25,6],[10,1,17,1],[10,5,10,7],[10,4,17,4],[16,5,16,7],[17,5,17,7],[20,1,20,6],[21,1,21,6],[22,1,22,6],[10,8,17,14],[11,5,11,7],[12,5,12,7],[13,5,13,7],[14,5,14,7],[15,5,15,7],[5,15,8,15],[0,1,4,15],[5,2,5,7],[8,8,8,9],[8,2,8,7],[8,10,8,14],[5,8,5,9],[5,10,5,14],[6,2,6,7],[7,2,7,7]]}
[null,"Sponsorship Review: Risk Assessment and HRA Criteria Check"]
[]
[]
[]
[]
[null,"Study Title:"]
[null,"R&I Number:"]
[null,"CI:"]
[null,"Study Coordinator:"]
[]
[null,"If Multi Centre, list participating sites (please indiate whether site is in Scotland/NI/Wales ):","Please list below:","Scotland/NI/Wales?",null,"Approvals needed (please choose all that apply):"]
[]
[]
[]
[]
[]
[]
[]
[]
[null,"Type of Study"]
[null,"Clinical trial of an investigational medicinal product"]
[null,"Clinical investigation or other study of a medical device"]
[null,"Combined trial of an investigational medicinal product and an investigational device"]
[null,"Other clinical trial to study a novel interveation, or randomised trial to compare interventions in clinical practice"]
[null,"Research database"]
[null,"Research tissue bank"]
[null,"Study involving qualitative methods only"]
[null,"Basic science study involving procedures with human participants"]
[null,"study limited to working with human tissue samples (or other human biological samples) and data (specific project only)"]
[null,"Study administering questionnaires/interveiews for quantitative analysis, or using mixed quantitative/qualitative methodology"]
[null,"Study involving staff only"]
[null,"Other study"]
[]
[null,"Risk assessment requirements"]
[]
[]
[null,"If IMP Study, complete sections below:"]
[null,"Type of IMP (please choose):",null,null,"Risks associated with trial IMP:"]
[null,"Biological"]
[null,"Chemical"]
[null,"Advanced Therapy"]
[null,"Other"]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[null,"Full","HRA","Yes"]
[null,"Proportionate","REC","No"]
[null,null,"MHRA"]
[null,null,"ARSAC"]
[null,null,"CAG"]
[null,null,"Other (please state)"]

{"sheet":"Risks","index":1,"n_rows":85,"n_cols":6,"rows_kept":85,"cut":false,"hidden":false,"merged":[[12,2,15,2],[12,0,17,0]]}
[]
[null,null,"Risk Summary","Clinical",{"$f":"AVERAGE(F19:F29)","v":0}]
[null,null,null,"Financial/Insirance",{"$f":"AVERAGE(F31:F40)","v":0}]
[null,null,null,"Reputation",{"$f":"AVERAGE(F42:F50)","v":0}]
[null,null,null,"Personnel",{"$f":"AVERAGE(F52:F54)","v":0}]
[null,null,null,"Facilities",{"$f":"AVERAGE(F56:F58)","v":0}]
[null,null,null,"Multi-Centre",{"$f":"AVERAGE(F60:F64)","v":0}]
[null,null,null,"Data Validity",{"$f":"AVERAGE(F66:F75)","v":0}]
[null,null,null,"Vendors",{"$f":"AVERAGE(F77:F80)","v":0}]
[null,null,null,"CtIMP/Device",{"$f":"AVERAGE(F82:F85)","v":0}]
[]
[null,"Area of Sponsor Risk Assessment","Issue Identified","Risk Level","Impact on participant","Total Risk Level             (Risk level + Impact)"]
["FiLTER THIS COLUMN IF STUDY ONLY REQUIRES PROPORTIONATE REVIEW",null,null,"4 - Risk is Unavoidable","2 - Highly likely to impact participants","Red = High"]
[null,null,null,"3 - Specific action required to avoid risk","1 - Potential impact on participants","Orange = Medium Risk"]
[null,null,null,"2 - Attention required to avoid risk","0 - Unlikley to have impact on participants","Green = Low "]
[null,null,null,"1 - Risk could occur if processes are breached"]
[null,null,null,"0 - No risk identified"]
[null,"CLINICAL"]
["Proportionate","Does the protocol require invesitgations or procedures that carry significant risk",null,null,null,{"$f":"D19+E19","v":0}]
["Proportionate","Does the study raise any questions with regards to other laws or guidance, e.g. the Human Tissue Act?  ",null,null,null,0]
[null,"Does the protocol require additional procedures over and above those which would be expected from standard care for the participant’s clinical condition",null,null,null,0]
["Proportionate","Level of investigator interaction with participant (Frequent contact/visits?)",null,null,null,0]
[null,"Are there potential communications barriers to informed consent or the ability to withdrawal) ",null,null,null,0]
[null,"Is the process for identifying potential participants and obtaining (where applicable) their consent clear and legally compliant?  ",null,null,null,0]
[null,"Is it clear that identification of potential participants prior to their consent is undertaken by an individual who should have access to their personal information (e.g. member of the normal care team) or that section 251 will be applied for?",null,null,null,0]
[null,"If the study involves patients under 16yoa who may become 16yoa whilst on study, are there appropriate arrangements and PIS/ICF to take their consent?",null,null,null,0]
[null,"Are arrangements for assessing patient capacity, and for what will happen should they lose capacity, clear?",null,null,null,0]
[null,"Are there risks to participant safety in relation to the study IMP (see types above)?",null,null,null,0]
[null,"Is an appropriate safety monitoring plan and  committee in place ",null,null,null,0]
["Proportionate","FINANCIAL/INSURANCE"]
["Proportionate","Has the study been costed appropriately with R&I input",null,null,null,{"$f":"D31+E31","v":0}]
["Proportionate","Is the study portfolio adopted",null,null,null,{"$f":"D32+E32","v":0}]
[null,"Has the study been fully costed",null,null,null,0]
[null,"Is there a contingency budget",null,null,null,0]
[null,"Do grant costs reflect the costs of the actual study, in accordance with the protocol etc",null,null,null,0]
[null,"Is it clear what funds/resources will be provided to site by the sponsor (and how this will be done)?",null,null,null,0]
[null,"If radiation being used, has an application to HRA Technical Assurance been costed? Please see the current project roll out status for more information.",null,null,null,0]
["Proportionate","Assess insurance risk",null,null,null,0]
[null,"Is equipment  being loaned or gifted to sites, or are sites are being provided funding to buy equipment? If so how will we ensure this is adequately covered in the SoA/Contract?",null,null,null,0]
[null,"Where particular equipment is required is it clear whether this will be provided to sites and on what basis?  If equipment is being loaned or gifted, is it clear what the indemnity arrangements are?  Is the equipment provider signed up to the MIA or will the loan/gift be governed by the site agreement?",null,null,null,0]
["Proportionate","REPUTATION"]
[null,"Nature of information sought, is this highly sensitive or personal",null,null,null,{"$f":"D42+E42","v":0}]
["Proportionate","Are the methods appropriate for the research questions",null,null,null,{"$f":"D43+E43","v":0}]
["Proportionate","Are there risks to patient rights related to consent, data protection or privacy",null,null,null,0]
["Proportionate","Is the research likely to be controversial",null,null,null,0]
["Proportionate","Risks to the reliability of trial results",null,null,null,0]
["Proportionate","Risks to impartiality of trial results, e.g. conflicts of interest",null,null,null,0]
["Proportionate","Are there other regulatory requirements to be considered",null,null,null,0]
[null,"Is radiation being used? ",null,null,null,0]
[null,"If radiation being used, is an application to HRA Technical Assurance needed? Please see the current project roll out status for more information.",null,null,null,0]
["Proportionate","PERSONNEL"]
["Proportionate","Researcher competence, experience and knowledge",null,null,null,{"$f":"D52+E52","v":0}]
["Proportionate","Team capacity to undertake study",null,null,null,{"$f":"D53+E53","v":0}]
[null,"Team history or recruiting to time and target",null,null,null,0]
["Proportionate","FACILITIES"]
[null,"Is clinic space available to undertake research  visits",null,null,null,{"$f":"D56+E56","v":0}]
[null,"Are agreements in place and capacity available for labs, pharmacy, radiology, other required facilities",null,null,null,{"$f":"D57+E57","v":0}]
["Proportionate","What are the arrangements for archiving?",null,null,null,0]
["Proportionate","MULTI-CENTRE"]
[null,"Is delegation of responsibility appropriately documented",null,null,null,{"$f":"D60+E60","v":0}]
[null,"Are monitoring arrangements in place and funded",null,null,null,{"$f":"D61+E61","v":0}]
[null,"Does each centre have a research team which has the competence, experience and knowledge to deliver the trial",null,null,null,0]
[null,"Does each centre have a research team which has a track record of recruiting to time and target",null,null,null,0]
[null,"Does each site have the facilites to suport the trial",null,null,null,0]
["Proportionate","DATA VALIDITY"]
[null,"Are there any risks relating to the CRF data",null,null,null,{"$f":"D66+E66","v":0}]
["Proportionate","Compliance with the Data Protection regulations and data security issues ",null,null,null,{"$f":"D67+E67","v":0}]
[null,"Is the randomisation process adequate?",null,null,null,0]
[null,"Is data management plan for the study robust, appropriate and realistic",null,null,null,0]
[null,"Have electronic databases been through appropriate validation",null,null,null,0]
[null,"Do e-databases /  eCRFs meet GCP / MHRA standards",null,null,null,0]
[null,"Confirmation eCRFs have full auditable capability",null,null,null,0]
[null,"Does databse accurately reflect the CRF",null,null,null,0]
[null,"Is there a suitable audit trail facility for the computer systems",null,null,null,0]
[null,"Is there a suitable Data Mangagement Plan in place",null,null,null,0]
["Proportionate","VENDORS"]
["Proportionate","Have all vendors been identified",null,null,null,{"$f":"D77+E77","v":0}]
[null,"Have all vendors been through due diligence",null,null,null,{"$f":"D78+E78","v":0}]
[null,"Have all vendors provided SOPs, contracts, ",null,null,null,0]
["Proportionate","Have all vendors contracts been agreed",null,null,null,0]
[null,"DEVICE/IMP (MHRA ONLY)"]
[null,"Are there any risks associated with IMP / Device accountability",null,null,null,{"$f":"D82+E82","v":0}]
[null,"Are there any risks relating to IMP / device storage",null,null,null,{"$f":"D83+E83","v":0}]
[null,"Are there any risks associated with IMP / device manufacture/labelling",null,null,null,0]
[null,"If pharmacy being used, has an application to HRA pharmacy review been costed? Please see the current project roll out status for more information.",null,null,null,0]

{"sheet":"Mitigation Plan","index":2,"n_rows":70,"n_cols":7,"rows_kept":70,"cut":false,"hidden":false,"merged":[[2,1,2,6],[60,1,60,6],[65,1,65,6],[14,1,14,6],[25,1,25,6],[35,1,35,6],[39,1,39,6],[43,1,43,6],[49,1,49,6]]}
[null,null,"Sponsor","Applicant","Sponsor","Applicant","Sponsor"]
["FiLTER THIS COLUMN IF STUDY ONLY REQUIRES PROPORTIONATE REVIEW","Area of Sponsor Risk Assessment","Required mitigation","mitigation plan/actions","Response to migigation proposal","Applicant response","Sponsor final response"]
["Proportionate","CLINICAL"]
["Proportionate","Does the protocol require invesitgations or procedures that carry significant risk",{"$f":"Risks!C19","v":0}]
[null,"Does the study raise any questions with regards to other laws or guidance, e.g. the Human Tissue Act?  ",{"$f":"Risks!C20","v":0}]
["Proportionate","Does the protocol require additional procedures over and above those which would be expected from standard care for the participant’s clinical condition",{"$f":"Risks!C21","v":0}]
[null,"Level of investigator interaction with participant (Frequent contact/visits?)",{"$f":"Risks!C22","v":0}]
[null,"Are there potential communications barriers to informed consent or the ability to withdrawal) ",{"$f":"Risks!C23","v":0}]
[null,"Is the process for identifying potential participants and obtaining (where applicable) their consent clear and legally compliant?  ",{"$f":"Risks!C24","v":0}]
[null,"Is it clear that identification of potential participants prior to their consent is undertaken by an individual who should have access to their personal information (e.g. member of the normal care team) or that section 251 will be applied for?",{"$f":"Risks!C25","v":0}]
[null,"If the study involves patients under 16yoa who may become 16yoa whilst on study, are there appropriate arrangements and PIS/ICF to take their consent?",{"$f":"Risks!C26","v":0}]
[null,"Are arrangements for assessing patient capacity, and for what will happen should they lose capacity, clear?",{"$f":"Risks!C27","v":0}]
[null,"Are there risks to participant safety in relation to the study IMP (see types above)?",{"$f":"Risks!C28","v":0}]
["Proportionate","Is an appropriate safety monitoring plan and  committee in place ",{"$f":"Risks!C29","v":0}]
["Proportionate","FINANCIAL/INSURANCE"]
["Proportionate","Has the study been costed appropriately with R&I input",{"$f":"Risks!C31","v":0}]
[null,"Is the study portfolio adopted",{"$f":"Risks!C32","v":0}]
[null,"Has the study been fully costed",{"$f":"Risks!C33","v":0}]
[null,"Is there a contingency budget",{"$f":"Risks!C34","v":0}]
[null,"Do grant costs reflect the costs of the actual study, in accordance with the protocol etc",{"$f":"Risks!C35","v":0}]
[null,"Is it clear what funds/resources will be provided to site by the sponsor (and how this will be done)?",{"$f":"Risks!C36","v":0}]
["Proportionate","If radiation being used, has an application to HRA Technical Assurance been costed? Please see the current project roll out status for more information.",{"$f":"Risks!C37","v":0}]
[null,"Assess insurance risk",{"$f":"Risks!C38","v":0}]
[null,"Is equipment  being loaned or gifted to sites, or are sites are being provided funding to buy equipment? If so how will we ensure this is adequately covered in the SoA/Contract?",{"$f":"Risks!C39","v":0}]
["Proportionate","Where particular equipment is required is it clear whether this will be provided to sites and on what basis?  If equipment is being loaned or gifted, is it clear what the indemnity arrangements are?  Is the equipment provider signed up to the MIA or will the loan/gift be governed by the site agreement?",{"$f":"Risks!C40","v":0}]
[null,"REPUTATION"]
["Proportionate","Nature of information sought, is this highly sensitive or personal",{"$f":"Risks!C42","v":0}]
["Proportionate","Are the methods appropriate for the research questions",{"$f":"Risks!C43","v":0}]
["Proportionate","Are there risks to patient rights related to consent, data protection or privacy",{"$f":"Risks!C44","v":0}]
["Proportionate","Is the research likely to be controversial",{"$f":"Risks!C45","v":0}]
["Proportionate","Risks to the reliability of trial results",{"$f":"Risks!C46","v":0}]
["Proportionate","Risks to impartiality of trial results, e.g. conflicts of interest",{"$f":"Risks!C47","v":0}]
[null,"Are there other regulatory requirements to be considered",{"$f":"Risks!C48","v":0}]
[null,"Is radiation being used? ",{"$f":"Risks!C49","v":0}]
["Proportionate","If radiation being used, is an application to HRA Technical Assurance needed? Please see the current project roll out status for more information.",{"$f":"Risks!C50","v":0}]
["Proportionate","PERSONNEL"]
["Proportionate","Researcher competence, experience and knowledge",{"$f":"Risks!C52","v":0}]
[null,"Team capacity to undertake study",{"$f":"Risks!C53","v":0}]
["Proportionate","Team history or recruiting to time and target",{"$f":"Risks!C54","v":0}]
[null,"FACILITIES"]
[null,"Is clinic space available to undertake research  visits",{"$f":"Risks!C56","v":0}]
["Proportionate","Are agreements in place and capacity available for labs, pharmacy, radiology, other required facilities",{"$f":"Risks!C57","v":0}]
["Proportionate","What are the arrangements for archiving?",{"$f":"Risks!C58","v":0}]
[null,"MULTI-CENTRE"]
[null,"Is delegation of responsibility appropriately documented",{"$f":"Risks!C60","v":0}]
[null,"Are monitoring arrangements in place and funded",{"$f":"Risks!C61","v":0}]
[null,"Does each centre have a research team which has the competence, experience and knowledge to deliver the trial",{"$f":"Risks!C62","v":0}]
[null,"Does each centre have a research team which has a track record of recruiting to time and target",{"$f":"Risks!C63","v":0}]
["Proportionate","Does each site have the facilites to suport the trial",{"$f":"Risks!C64","v":0}]
[null,"DATA VALIDITY"]
["Proportionate","Are there any risks relating to the CRF data",{"$f":"Risks!C66","v":0}]
[null,"Compliance with the Data Protection regulations and data security issues ",{"$f":"Risks!C67","v":0}]
[null,"Is the randomisation process adequate?",{"$f":"Risks!C68","v":0}]
[null,"Is data management plan for the study robust, appropriate and realistic",{"$f":"Risks!C69","v":0}]
[null,"Have electronic databases been through appropriate validation",{"$f":"Risks!C70","v":0}]
[null,"Do e-databases /  eCRFs meet GCP / MHRA standards",{"$f":"Risks!C71","v":0}]
[null,"Confirmation eCRFs have full auditable capability",{"$f":"Risks!C72","v":0}]
[null,"Does databse accurately reflect the CRF",{"$f":"Risks!C73","v":0}]
[null,"Is there a suitable audit trail facility for the computer systems",{"$f":"Risks!C74","v":0}]
["Proportionate","Is there a suitable Data Mangagement Plan in place",{"$f":"Risks!C75","v":0}]
["Proportionate","VENDORS"]
[null,"Have all vendors been identified",{"$f":"Risks!C77","v":0}]
[null,"Have all vendors been through due diligence",{"$f":"Risks!C78","v":0}]
["Proportionate","Have all vendors provided SOPs, contracts, ",{"$f":"Risks!C79","v":0}]
[null,"Have all vendors contracts been agreed",{"$f":"Risks!C80","v":0}]
[null,"DEVICE/IMP (MHRA ONLY)"]
[null,"Are there any risks associated with IMP / Device accountability",{"$f":"Risks!C82","v":0}]
[null,"Are there any risks relating to IMP / device storage",{"$f":"Risks!C83","v":0}]
[null,"Are there any risks associated with IMP / device manufacture/labelling",{"$f":"Risks!C84","v":0}]
[null,"If pharmacy being used, has an application to HRA pharmacy review been costed? Please see the current project roll out status for more information.",{"$f":"Risks!C85","v":0}]

{"sheet":"HRA checklist","index":3,"n_rows":102,"n_cols":5,"rows_kept":102,"cut":false,"hidden":false,"merged":[[76,1,76,3],[78,1,78,3],[0,1,0,3],[3,1,3,3],[4,1,4,3],[49,1,49,3],[57,1,57,3],[63,1,63,3],[65,1,65,3],[70,1,70,3],[2,1,2,3],[1,1,1,3],[6,1,6,3],[15,1,15,3],[38,1,38,3]]}
[null,"This checklist provides a comprehensive list of items that must be covered in your protocol and accompanying documentation. Completing this checklist ensure that the study is compliant with relevant regulations and also that it meets the HRA assessment criteria. "]
[null,"INSTRUCTIONS:"]
[null,"1) Please work through this list, addressing each item, and indicate in the yellow column that you have addressed each item (some items may be n/a for certain studies in which case please indicate this in the N/A column)."]
[null,"2) For certain studies, only those items in this checklist marked with a * need completing. "]
[null,{"$f":"IF('Study Detail'!B35=\"proportionate\",B102,B101)","v":"For this study, you are required to complete all of the items in this checklist (non-CtIMPs are excempt from completing the CTIMP section). "}]
[null,null,"Complete","N/A"]
[null,"IRAS"]
["*","Has HRA approval been selected within the project filter questions in IRAS? This is selected by choosing “IRAS FORM”",null,null,"*"]
["*","Does the IRAS project filter category accurately reflect the study as described in the application form, protocol and PIS?  For more information please select the green \"i\" icon in IRAS",null,null,"*"]
[null,"Is exposure to ionising radiation required by the protocol? Is this stated in the IRAS form in section 2b?"]
[null,"Will samples (new or existing) be taken? Is this stated in the IRAS form in section 2b?"]
["*","Will the study take place in Wales, Scotland or Ireland, does Part C reflect this?",null,null,"*"]
["*","Has the appropriate filter been selected if participants aged under 16 years of age might be involved (question 6), or adults unable to consent (question 7) for themselves.",null,null,"*"]
[null,"Has the R&I Clinical Trials Manager, Clinical Trials Officer, or Research Operations Manager been listed as the contact on behalf of the Sponsor, and the contact email address given as researchsponsor@nbt.nhs.uk?"]
["*","Has researchsponsor@nbt.nhs.uk been provided as the email address for sponsor representative in section A4 and A64 of IRAS.",null,null,"*"]
[null,"Participant Information Sheets (PIS) and Consent Forms"]
[null,"Do the documents have the NBT logo?"]
[null,"Has the Research Ethics Committee Participant Information Sheet and Consent Form guidance and templates been used (available at http://www.hra-decisiontools.org.uk/consent/docs/PIS-Template_version1.pdf)? R&I srequire the use of these templates for all projects."]
[null,"Is all study documentation consistent with one another (Protocol, IRAS form, etc)? Please read all documents thoroughly to check for inconsistencies. "]
[null,"Is the patient documentation appropriately version controlled (e.g. “Document Name, Full Document Date, Document Version Number”)?"]
[null,"Is the full title and IRAS reference present on the information/consent forms (full title is mandatory except in cases where inclusion of the full study title would not be appropriate)?"]
[null,"Does the patient documentation clearly outline how participant data (and tissue if relevant) will be used and who it will be shared with, and what will happen to it including after the end of the study?"]
[null,"If there are any potential further uses or disclosures regarding the data, are these clearly outlined? For example, if you plan to register for the Health and Social Care Information Centre (HSCIC)."]
[null,"Is it clear in the documentation who will be allowed to identify participants and make the first approach, and who will access identifiable information in order to identify potential participants? Searching records for potential subjects should meet legal requirements (e.g. with consent, by someone with a legitimate relationship to those patients such as a clinical worker, or by part of the clinical team)."]
[null,"Are post study arrangements (e.g. continued access to IMP/treatment) where applicable, clear in the PIS and consistent across the PIS, protocol and application form?  If continued access is offered is there any information on how this will be funded/arranged?  "]
[null,"Where personal data will be leaving the European Economic Area (EEA) (in identifiable format) will explicit consent be taken (e.g. a specific box in the Consent Form?"]
[null,"If there are multiple PISs/ICFs is it clear which should be used in which circumstances/with which patient group?"]
[null,"If tissue is to be taken, is it clearly and consistently stated (including to the participant in the PIS) what will be done to it where and what will happen to it after the study?  "]
[null,"Participant Information Sheet: Does the PIS clearly state the study aims and participant arrangements for involvement?"]
[null,"Participant Information Sheet: A statement regarding indemnity/insurance and compensation arrangements must be present within the information sheet. Please insert the following statement about indemnity/insurance arrangements into the PIS: ‘In the unlikely event that something does go wrong, and you are harmed during the research study there are no special compensation arrangements. If you are harmed and this is due to someone’s negligence then you may have grounds for a legal action for compensation against North Bristol NHS Trust but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.’"]
[null,"Participant Information Sheet: Does the information sheet give a point of contact for queries/complaints including an independent contact such as PALS? "]
[null,"Participant Information Sheet: Are expectations of care after the research clearly communicated so patients are not mislead?"]
[null,"Participant Information Sheet: Does the information sheet state what the arrangements are post-study (this is particularly important for CTIMPS and device studies)?"]
[null,"Participant Information Sheet: Is it clear what will happen to personal data after the end of the study?"]
[null,"Participant Information Sheet: If the study is a CTIMP, does the patient documentation clearly describe the intervention/drug, its stage of development, and any potential side effects? If the trial is comparing one of the standard care medications, it is acceptable for the PIS to state that the side effects are described in the product information leaflet."]
[null,"Consent Form: The following statement should be included: \"I understand that relevant sections of my medical notes, and data collected during\nthe study, may be looked at by individuals from the research team, the regulatory authorities \nor the XXX Hospital Trust overseeing the research. I give permission for these individuals to have\naccess to the relevant parts of my medical records.\" \n"]
[null,"Participant Information Sheet: Wording must be included regarding the protection of personal data. Please include the wording as outlined on the HRA website: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/transparency-wording-public-sector/"]
[null,"Participant Information Sheet:  Wording must be included regarding the protection of personal data. Please include the wording as outlined on the HRA website: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/transparency-wording-public-sector/"]
[null,"Protocol"]
["*","Does the information in the protocol match with the study documentation? Please read all documents thoroughly to check for inconsistencies.",null,null,"*"]
[null,"If the tissue is to be retained post study, have you liaised with R&I to ensure are appropriate arrangements in place (e.g. licensed tissue bank)?"]
[null,"Are arrangements outlined for what will happen to a participant and their data/material should they withdraw consent or lose capacity to consent clear and consistent?"]
["*","Is the protocol appropriately version controlled (e.g. “Document Name, Document Date, Document Version Number”)?",null,null,"*"]
["*","Does the protocol provide a clear description of the study including the objectives, design, methodology, statistical considerations (or other methods of data analysis) and the organisation of the study?",null,null,"*"]
["*","Does the protocol describe the monitoring arrangements for the study and dissemination of the study findings? ",null,null,"*"]
[null,"If the study is a CTIMP, has the HRA protocol template been used? It is an NBT requirement that the HRA template protocol is used for all NBT sponsored CTIMPS (http://www.hra.nhs.uk/about-the-hra/consultations-calls/closed-consultations/protocol-guidance-template-use-clinical-trial-investigational-medicinal-product-ctimp-consultation-use/) and that the additional requirements outlined in NBT’s SOPs have been incorporated (see SOP RI/QMS/SOP/008, available via: https://www.nbt.nhs.uk/research-innovation/study-set/standard-operating-procedures-policies) "]
[null,"Do CRFs reflect data collection in protocol"]
[null,"If equipment is being loaned or gifted, has it been discussed with the Sponsor what the indemnity arrangements are?  "]
[null,"Has the protocol has undergone independent scientific and statistical review, and is this outlined in the application?"]
[null,"Data protection"]
["*","Does the study documentation consistently describe how personal data will be used? This should include description of the flow of data between parties involved in the research, who will access the data, what data they will access, and whether this is covered by consent",null,null,"*"]
[null,"Is clear and adequate justification provided as to why any identifiable data is being accessed without consent, or personal data is to be transferred outside of the European Economic Area (EEA)?"]
["*","Does the application describe how the data will be stored and what security measures are in place to keep it secure?",null,null,"*"]
[null,"Does the application describe whether the data is to be coded or anonymised, the methods for doing so, and why? If identifiable data is to be used, a minimum necessary amount of identifiable information should be used."]
["*","If data is being transported from the site where it is collected, is this discussed (in the protocol for example)? Consideration should be given to the security of data when transporting it, either on paper or electronically (e.g. USB)",null,null,"*"]
["*","Does the protocol adequately describe the activities to be conducted at site (including where and how these may alter between different sites)?  ",null,null,"*"]
["*","Does the protocol include details of indemnity? Standardised wording that should be used is provided in NBT R&I SOP for Writing a Protocol (see SOP RI/QMS/SOP/007, available via: https://www.nbt.nhs.uk/research-innovation/study-set/standard-operating-procedures-policies)",null,null,"*"]
[null,"Statement of Activities/Schedule of Events (If you would like support in completing these documents, please contact us on researchsponsor@nbt.nhs.uk)"]
["*","If the study is multi-centre or is a single centre study undertaken at a non-NBT site, have Statement of Activities (SoA) and Schedule of Events (SoE) documents been prepared, using the templates available at: http://www.hra.nhs.uk/resources/hra-approval-applicant-guidance/statement-activities-hra-approval/ ? If your project is a multi-centre project, one version of the SoA and SoE is adequate if all sites are undertaking the same research activities. If different sites are undertaking different research activities, a separate Statement of Activities and Schedule of Events would be needed for each site ‘type’.  ",null,null,"*"]
["*","Does the SoA describe the costs associated with the study, and what (if any) funding is to be provided to each site type?",null,null,"*"]
["*","Does the SoA state whether or not a PI / Local Collaborator is required for each site, as and whether these have already been identified?",null,null,"*"]
[null,"If equipment is being loaned or gifted, or sites are being provided funding to buy equipment, has it been discussed with the Sponsor to ensure this is adequately covered in the SoA/Contract?"]
["*","Has R&I reviewed and approved the SoA/SoE documents? All SoA and SoE documents need to be submitted with the HRA application, and must be checked/confirmed with R&I beforehand.",null,null,"*"]
[null,"Site Agreements"]
[null,"Have you liaised with R&I to discuss which agreement(s) may be necessary during the conduct of the trial? Template agreements will need to be submitted with the HRA application, and must be checked/confirmed with R&I beforehand."]
[null,"Financial Arrangements"]
[null,"Have letters from funders (if applicable) been obtained? These must be submitted to the HRA."]
[null,"If the project indicates that post-study therapies will be afforded to participants, have you included evidence in your application to confirm how this access will be funded and managed?"]
["*","Does the application demonstrate an understanding of the costs associated with supporting the study?",null,null,"*"]
["*","Where the study is funded through a programme grant, does the IRAS application reflect the amount (or %) of funding to be used for this particular study?",null,null,"*"]
[null,"Other Legal Requirements"]
[null,"Is the Protocol compliant with the appropriate regulations i.e., The UK Policy Framework for Health and Social Care Research (v.3.3, 07/11/17) Department of Health Research Governance Framework for Health & Social Care (2nd ed. Apr 2005); The World Medical Association Declaration of Helsinki (2000); Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended); ICH Guidelines for Good Clinical Practice(GCP) (E6 (R2), Step 4, 2016)(Step 5 Version July 2002); , Human Tissue Act 2004; Mental Capacity Act 2005; Data Protection Act 2018 and the General Data Protection Regulation1998? For advice about compliance, please liaise with the R&I department."]
[null,"If the study involves intrusive research (that which would be unlawful if carried out on or in relation to a person who had consent, but without this consent) involving adults unable to consent for themselves, advice on the assumed will of the adult must be obtained from a nominated consultee.  In these cases, has a consultee information sheet/declaration form been included in the application? Or Legal Representative if a CTIMP with Adults who Lack Capacity."]
[null,"If the study involves human tissue, does the application outline how the tissue will be obtained, the consent with which tissue is used, any licences required to use/store the tissue, how tissue is being handled, and arrangements for storage and disposal?"]
["*","Does the application clearly outline the insurance and indemnity arrangements for the management, design and conduct of the study?",null,null,"*"]
[null,"If your research involves the administration of radioactive substances then please ensure that you apply for the appropriate ARSAC approval (http://www.hra.nhs.uk/research-community/applying-for-approvals/administration-of-radioactive-substances-advisory-committee-arsac )"]
[null,"Human Resources"]
["*","The HRA will confirm what HR arrangements (e.g. Letters of Access) are needed where activities are undertaken by staff who do not already hold contracts of employment with the organisation where that activity will take place. Therefore, have you ensured that all members of the research team are clearly listed in the application?",null,null,"*"]
[null,"Other considerations – CTIMP TRIALS ONLY"]
[null,"Please ensure you apply for and obtain an MHRA Clinical Trial Authorisation (or acknowledgement for Type A trials) from the MHRA. You will need to submit your MHRA approval letter to the HRA before the HRA will issue approval"]
[null,"Does the Protocol clearly set out the arrangements for the conduct of the CTIMP at participating sites so they are clear what is expected of them? You will also need to liaise with R&I to ensure this is covered in the Clinical Trial Agreement and SoA/SoE where relevant."]
[null,"Does the application clearly outline any delegated roles and responsibilities (i.e. activities the sponsor has delegated to a third party)?"]
[null,"Have arrangements for the management of the CTIMP at the research sites been described, including monitoring and source data verification? You need to liaise with R&I to determine the monitoring plan for the study."]
[null,"Are processes for managing trial safety, including pharmacovigilance and the process for reporting adverse events, described in the protocol? Please ensure this aligns with NBT SOP RI/QMS/SOP/013, available via: https://www.nbt.nhs.uk/research-innovation/study-set/standard-operating-procedures-policies."]
[null,"Are arrangements regarding IMP handling, storage, reparation and dispensing, clearly described?"]
[null,"Are arrangements for the storage of trial materials (including documents and samples) clearly described and in line with R&I SOPs?"]
[null,"Are arrangements for consent in relation to children and/or adults lacking capacity in line with the relevant legislations (e.g. Mental Capacity Act 2005, Clinical Trial Regulations 2004)"]
[null,"Are monitoring and pharmacovigilance arrangements clearly described and in line with the NBT R&I Monitoring and Reporting SOPs?"]
[null,"Have the research contracts been discussed and agreed with the Sponsor?"]
[null,"Are the requirements for the logging and calibration of equipment detailed in the application?"]
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[null,"For this study, you are required to complete all of the items in this checklist (non-CtIMPs are excempt from completing the CTIMP section). "]
[null,"This study is subject to proportionate risk assessment, therefore you are only required to compelete the items in this checklist marked with *"]

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