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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 Click here to access the resource |
| 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 Click here to access the resource |
| 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 Click here to access the resource |
| ETC Issue Collection Template | |
| Type: Tool Author: NHSE/DH Keywords: ETC, Acord, costs, funding Link Reference: 165 Click here to access the resource |
| 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 Click here to access the resource |