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

Principal Investigators’ Signatures

Aligning the existing eCF best practices document with the most recent regulatory expectations

Principal Investigators’ Signatures

Aligning the existing eCF best practices document with the most recent regulatory expectations

eConsent

Evaluating the currently available data on the implementation of Electronic Consent

  • 17 October 2019
  • Author: Webmaster1
  • Number of views: 3039
  • 0 Comments
eConsent

Evaluating the currently available data on the implementation of Electronic Consent

eCOA Data Changes

Best Practices for eCOA Data Changes

  • 14 May 2019
  • Author: Webmaster1
  • Number of views: 2545
  • 0 Comments
eCOA Data Changes

Best Practices for eCOA Data Changes

Audit Trail Review

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 2835
  • 0 Comments
Audit Trail Review

Best practices for meeting regulatory expectations for Audit Trail Review

Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 2454
  • 0 Comments
Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

Trial of the Future

  • 1 May 2018
  • Author: Webmaster1
  • Number of views: 2333
  • 0 Comments
Trial of the Future

Evaluating emerging technologies and processes and their impact on the future of clinical trials

eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

  • 1 March 2018
  • Author: Webmaster1
  • Number of views: 2550
  • 0 Comments
eSRA Maintenance

Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.

PI Signatures - ENDED

Evaluating regulations and guidances pertaining to principal investigator signatures on study data and materials

  • 2 November 2016
  • Author: Webmaster1
  • Number of views: 2079
  • 0 Comments
PI Signatures - ENDED

Evaluating regulations and guidances pertaining to principal investigator signatures on study data and materials

Regulatory Expert Group (REG)

Maintaining group expertise in regulatory environment

  • 5 May 2015
  • Author: Webmaster1
  • Number of views: 2199
  • 0 Comments
Regulatory Expert Group (REG)

Maintaining ECF expertise in the regulatory environment and trends

EDC Hosting - ENDED

  • 26 November 2013
  • Author: Webmaster1
  • Number of views: 1879
  • 0 Comments
EDC Hosting - ENDED

Best practices for data transcribed to electronic data collection tools

Risk-Based monitoring - ENDED

  • 15 May 2012
  • Author: Webmaster1
  • Number of views: 1869
  • 0 Comments
Risk-Based monitoring - ENDED

Best practices for ensuring clinical data quality

EHR4CR - ENDED

  • 15 March 2011
  • Author: Webmaster1
  • Number of views: 2379
  • 0 Comments
EHR4CR - ENDED

Re-use of Electronic Health Records for Clinical Research

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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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