The Clinical Forum’s Essential Records Team is pleased to announce the public release of the rComputerised Systems Essential Records (CSER) List.

This CSER List is designed to support sponsors in identifying, selecting, and documenting the essential data and metadata that must be retained to accurately reconstruct the conduct of a clinical trial after decommissioning from the computerised system.

の日本語版2025.2JP1が2026年6月02日にリリースされました。

The eCF Requirements Public Release PR2025 is now available for free download on our Downloads page. For eClinical Forum members, the Members Release MR2026 is also now available in the Members Section. 

The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review". 

の日本語版2025.2JP1が2025年6月30日にリリースされました。

The eClinical Forum is releasing its 8th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA, TFDA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

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.

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

The "eCF Requirements" Members Release V2024 has been released.  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  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 and ISO.

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 intent of this document is to provide a framework for individuals’ risk‐based decisions and best practices for implementing solutions for investigators’ signature collection on data reported to sponsor.

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.