Resource Exchange
Search Category: Electronic Health Records Compliance /e-Source
| 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 Click here to access the resource |
| Electronic Health Records | |
| Type: Blog Author: Jennifer Martin MHRA Keywords: Sponsor, site. EHR, GCP, Compliance, audit trails, access & security, GDPR Link Reference: 775 Click here to access the resource |
| 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 |
| MHRA Position Paper & Guidance: Electronic Health Records | |
| Type: Paper Author: MHRA Keywords: MHRA, Electronic Health Records, GCP, EHR Link Reference: 317 Click here to access the resource |