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.

 

NEWS FROM THE ECF

Japanese translation of eSRA V2022

Japanese translation of eSRA V2022

Version 2022.1JP1 (10-May-2022)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

Members Release: Best Practice Document on Investigator’s Signature

Members Release: Best Practice Document on Investigator’s Signature

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), MR2022”.

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. 

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021

4-April-2022

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.

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

  • 31 March 2022
  • Author: Webmaster1
  • Number of views: 31095
  • 0 Comments
eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

Version 2022.2 (25-May-2022; only the license agreement for those re-using in another form has been updated)

This is the ONE FILE that you need to perform an eSRA Assessment.

Difference between eSRA V2022 and eSRA V2021

Difference between eSRA V2022 and eSRA V2021

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

"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

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

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

JAPANESE TRANSLATION of eSRA Handbook and Webinar

eSRA Version 2021

JAPANESE TRANSLATION of eSRA Handbook and Webinar

This is the 2021JP1 version.

RESULTS: Investigator Site Survey

2019

  • 31 October 2019
  • Author: Webmaster
  • Number of views: 24653
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RESULTS: Investigator Site Survey

Voluntary Investigator Site Survey survey concluded with 528 responses.

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

  • 1 October 2019
  • Author: Webmaster1
  • Number of views: 6864
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Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

  • 15 June 2017
  • Author: Webmaster
  • Number of views: 13333
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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...

Electronic Informed Consent Technology Showcase - An Excellent Event

Event Feedback

  • 30 November 2016
  • Author: Webmaster
  • Number of views: 14583
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Electronic Informed Consent Technology Showcase - An Excellent Event

We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.

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

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.

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