"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.
This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators. Address the problem of generic regulations and create industry guidelines more tangible and actionable.
Team started in August 2024. The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor companies and technology vendors.
The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.
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. Read more
Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.
Aligning the existing eCF best practices document with the most recent regulatory expectations
Best practices for meeting regulatory expectations for Audit Trail Review
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Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023
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.
eCF APAC Autumn Workshop 2024 Announced
Registration is open! Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification
This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions. The discussion will be around:
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.