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Regulatory Expert Group (REG)

Maintaining group expertise in regulatory environment

  • 5 May 2015
  • Author: Webmaster1
  • Number of views: 1107
Regulatory Expert Group (REG)

The REG Advisory Group provides expert evaluation of regulatory guidance from Europe, North America and Asia Pacific so that the impact on Clinical Research, such as system criteria, can be assessed. Consolidation of review comments via this group ensures that the eCF can respond efficiently to regulatory agency timetables for return of comments. A major deliverable from REG is the "eCF Requirements" (a set of statements, all based on regulatory documents from FDA, EMA, PMDA, MHRA, NMPA and ICH, that make up the minimal requirements a system that is originating or managing data for clinical research must adhere to). The "eCF Requirements" are released annually to the eClinical Forum member companies. Previous year’s eCF Requirements may be released to the public. eCF Member companies use the eCF Requirements to assist in system evaluations, RFIs and other regulatory and audit activities. Member companies believe that the time saved by using the eCF Requirements (rather than evaluating all the regulatory documents from different authorities on their own) justifies the cost of eClinical Forum membership. The REG Advisory Group is comprised of one regulatory expert from each of the eCF member companies and meets twice/month. They welcome feedback/questions on the eCF Requirements and will respond to each one. Feedback/questions can be sent to REG@eClinicalForum.org. 


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«August 2021»
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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