"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
Aligning the existing eCF best practices document with the most recent regulatory expectations
Evaluating the currently available data on the implementation of Electronic Consent
Best Practices for eCOA Data Changes
Best practices for meeting regulatory expectations for Audit Trail Review
Developing a position paper from the industry on the electronic archiving of study data and related topics
Evaluating emerging technologies and processes and their impact on the future of clinical trials
Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.
Evaluating regulations and guidances pertaining to principal investigator signatures on study data and materials
Maintaining ECF expertise in the regulatory environment and trends
Best practices for data transcribed to electronic data collection tools
Best practices for ensuring clinical data quality
Re-use of Electronic Health Records for Clinical Research
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Public Release: English Translation of V2.00 of Japan EDC Management Sheet
The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00. EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.