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

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

Select recordings available

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.

Views & News -- October 2022

eCF's monthly e-newsletter - “Keeping you Current”

Views & News -- October 2022

We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org.   Click "Read More" to see this month's "Views & News"!

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.

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)

eSRA V2022 (eSource Readiness Assessment) Handbook and Assessment Questionnaire

  • 31 March 2022
  • Author: Webmaster1
  • Number of views: 37764
  • 0 Comments
eSRA V2022 (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.

Implementing eSRA: Sponsor Perspective

Implementing eSRA: Sponsor Perspective

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022)

Difference between eSRA V2022 and eSRA V2021

Difference between eSRA V2022 and eSRA V2021

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Release 2022

  • 29 March 2022
  • Author: Webmaster1
  • Number of views: 8271
  • 0 Comments
Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

eSRA was used in a Japanese research paper on data quality of medical information systems

Japan Society for Medical Informatics

eSRA was used in a Japanese research paper on data quality of medical information systems

Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."

"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

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

An Industry Position Paper

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback.  With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool.  This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.

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eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials

eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials

The clinical trial industry is undergoing a rapid transition toward decentralization, where some or all health assessments are performed remotely in participants’ homes instead of in medical centers. Adopting artificial intelligence in this setting can empower more patients to enroll in trials, successfully complete them without burden, and submit high-fidelity assessments of their health. In this talk, the presenters will discuss insights from their recent article in Nature Medicine on this topic.  The article can be viewed at: Artificial intelligence can improve patients’ experience in decentralized clinical trials | Nature Medicine

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