LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

 

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ECF Teams and Projects

Regulatory Expert Group (REG)

Regulatory Expert Group (REG)

Maintaining group expertise in regulatory environment

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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