The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.

Version 2023.2JP1 (18-Sep-2023)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

 

The Archiving and Decommission Team is pleased to announce the public release of three white papers:

• "The Decommissioning of Computerised Systems Used in Clinical Trials" 
• "Nature of a Distributed Trial Master File ‐ Practical Aspects"
• "Data Formats Used in Clinical Trials"

These white papers were written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

The joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.

The DCT Working Group is a joint effort between eClinical Forum and EUCROF. The team's objectives are to define DCT terms and to develop position papers and roadmaps on DCT solutions that simplify patient and site experiences. 

Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.

The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback.  With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool.  This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.

We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.

The eCF is releasing 3 documents via the eCF website “Members” area (un/pw required).  Please feel free to download them and share with other members of your company.