LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.

ECF Teams and Projects

Japanese Translation: eSRA Handbook and Assessment Forms V2025 30 June 20250

Japanese Translation: eSRA Handbook and Assessment Forms V2025

の日本語版2025.2JP1が2025年6月30日にリリースされました。

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 27 April 20250

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

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".

Japanese translation of Inv Site File Assessment V2024 25 November 20240

Japanese translation of Inv Site File Assessment V2024

Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)

08 November 2024

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.

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 15 July 20240

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

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".

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”) 05 July 20240

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “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.

Japanese translation of eSRA V2024 20 May 20240

Japanese translation of eSRA V2024

Version 2024JP1:  Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

AI state-of-play around clinical research 02 October 20230

AI state-of-play around clinical research

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.

01 October 2022

Investigator’s signature on electronic Case Report Forms (eCRFs)

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.

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