"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.
The "eCF Requirements" have been released to eCF Members Only. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH. This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document. This V2024 release builds upon the V2023.3 release with additional mappings to regulatory authority documents.
If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason, the most current version of this document is always released for eClinical Forum members only eCF Members can obtain a copy by sending an email to REG@eclinicalforum.org. We also have a public release of the V2023 (last year’s eCF Requirements). This is available to non-members and can be downloaded from our website: Downloads (eclinicalforum.org).
The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org
Non-members who would like more information on becoming a member, should look at Membership (eclinicalforum.org) and/or contact Info@eclinicalforum.org
NOT A MEMBER?
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.