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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

  • 15 June 2017
  • Author: Webmaster
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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. The work of the eClinical Forum in the areas of contractual requirements and risk-based software validation was presented…

  • - Industry best practices for contracting of trial-related services within today’s dynamic technology, compliance and stakeholder environment.
  • - Core user requirements for computer system evaluation that is already being leveraged within healthcare and research to provide standardised tools to evaluate risk and to develop risk management and mitigation strategies.

 

 

This work has been extensively referenced and is available for download from the downloads page of the website

Discussion allowed the two sides to better understand requirements, current concerns and potential solutions. Further meetings are planned.

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eCF Focus Session:  Audit Trail Review in Practice

eCF Focus Session:  Audit Trail Review in Practice

The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”.  (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) )  Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.

This is a two-hour focus session. The first hour will be presentations of case-studies from eClinical Forum members. The second hour will be a round-table discussion.

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