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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.
There has been a request from our members to develop a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations. This would be similar to what we already offer (for free) to sites around the globe to evaluate their EHR systems or other systems that originate data that may become part of a clinical trial (this questionnaire is called “eSRA” for “e-Source Readiness Assessment” and can be found on our website at eSRA (eclinicalforum.org)). The team is under the guidance of the eCF REG team, which produces the “eCF Requirements” that the eSRA and ISF assessments are based on. A Pilot of the eISF Assessment Questionnaire and Handbook was run in 2023. We anticipate a public/free release of this product in early 2024. For more information or to become involved in this team, members should send an email to ISFA@eclinicalforum.org.
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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.