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.


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ECF Teams and Projects

Public Release: English Translation of V2.00 of Japan EDC Management Sheet 01 July 20220

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

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.

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021 04 April 20220

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021"

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 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.

02 December 2021

Submission of comments on EMA’s draft “Guideline on computerised systems and electronic data in clinical trials”

These comments are provided by a team with representatives from 13 eCF member companies and have been reviewed by the eClinical Forum members. Those on the team are from Sweden, UK, Switzerland, Belgium, Spain, Germany, Italy, United States, and Japan. They represent many hours of personal review/comment as well as 19 hours of team discussion. The larger eCF Membership had opportunity to review and comment as well.  The resulting submitted comments (59 pages) are a consensus of member opinion.

"When should audit trail begin?" 17 June 20210

"When should audit trail begin?"

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 

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here 05 May 20210

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021

Applied Clinical Trials publishes article on eCF Requirements 15 July 20190

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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

Member Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only 27 April 20180

Member Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements 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 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 data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

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ECF REPRESENTATIVES MEET WITH EMA GCP IWG 15 June 20170

ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

Regulatory Expert Group (REG) 05 May 20150

Regulatory Expert Group (REG)

Maintaining ECF expertise in the regulatory environment and trends