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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.
The Archiving and Decommission Team is pleased to announce the public release of three white papers:
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.
This is the ONE FILE that you need to perform an eSRA Assessment.
How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2023)
What has changed?
The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022"
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.
The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00. EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022)
Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
We welcome feedback! Please send to: REG@eclinicalforum.org
This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021
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eClinical Forum In-Person and Remote Workshop, Blue Bell, PA
We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.
This workshop will be available for face-to-face and remote participation.
We hope you can join us!
REGISTRATION IS OPEN: eClinical Forum Hybrid Workshop, Darmstadt, Germany June 14-16, 2023
We are pleased to announce that registration is now open for our next European Workshop in Darmstadt Germany on June 14-16 hosted by eClinical Forum.
This hybrid workshop is available for face-to-face or remote participation.
READ MORE to download Agenda
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