FREE TO DOWNLOAD

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

TELL ME MORE ABOUT MEMBERSHIP...

 

Downloads

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.

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

Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022

MR2022, 4-April-2022

This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over several years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from FDA, EMA, PMDA, MHRA, NMPA and ICH.  This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document.  If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly.  One of the eCF Members benefits is a full year of the most recent version of the eCF Requirements prior to it being released to the public. At this time, the public have access to "eCF Requirements PR2021" via the Download section of this website.

 The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org

Documents to download

Print

Categories: Regulatory, Visible by MEMBERS ONLY, ReportNumber of views: 5502

Tags: