Resource Exchange: Search Results Title

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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Type: Example Infographic
Author: Sally Humphreys, West Suffolk NHS Foundation Trust
Keywords: Essential documents, GCP, clinical trials,
Link Reference: 297
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Type: Tool
Author: NHSE/DH
Keywords: ETC, Acord, costs, funding
Link Reference: 165
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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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Type: Website resources
Author: Ethnic Minority Research Inclusion
Keywords: Translation, validity measures, languages, clinical assessment tools, screening, quality of life, survey, questionnaires, scale, measure, accessibility
Link Reference: 65772
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