NEWS FROM THE ECF

"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 

Regulatory Advisory Group (REG)

  • 1 May 2018
  • Author: Webmaster1
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Regulatory Advisory Group (REG)

The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites).

eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

  • 1 March 2018
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  • Number of views: 4695
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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.

MEMBERS: Submission of comments to FDA on Draft eSource Guidance

  • 12 March 2013
  • Author: Webmaster1
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MEMBERS: Submission of comments to FDA on Draft eSource Guidance

The eClinical Forum held an open discussion with members from pharma, CROs, and associated software vendors, to talk about this draft FDA guidance on Jan 8, 2013.  The resulting comments are a consensus of member opinion. They have been submitted to the FDA on March 12, 2013.

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