Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

Version 2024JP1:  Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

The regulatory overview presented in this paper shows that while regulations are far from final for all use cases, the US and Europe have made the biggest steps toward monitoring and facilitating the use of AI, and regulations are in development in other regions around the globe.

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1"

About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor.  eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor. 

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.

Voluntary Investigator Site Survey survey concluded with 528 responses.

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.