Advisory Group - eClinical Forum

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The eClinical Forum Download area contains publically available surveys, presentations, articles and reports that can inform your decision making, challenge your thinking, and identify new technological and regulatory trends related to eClinical trials.

A much more extensive archive of information is available to members.

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Disclaimer:The information presented in these works draws upon the combined understanding and knowledge of the eClinical Forum and is provided as an aid to understanding the environment for electronic clinical research. The opinions of the author(s) and the eClinical Forum do not necessarily reflect the position of individual companies.The content is unconfirmed and users should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.

These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

17Jun2021

"When should audit trail begin?"

17 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...

1May2018

Regulatory Advisory Group (REG)

01 May 2018

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).

1Mar2018

eSRA Maintenance

01 March 2018

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.

12Mar2013

MEMBERS: Submission of comments to FDA on Draft eSource Guidance

12 March 2013

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...