Industry Feedback on Draft Standard Now Under Review

Following a consultation period in which industry representatives were provided with an opportunity to review the draft TMF Exchange Mechanism Standard, their feedback is now being reviewed by the Exchange Mechanism business and vendor teams. Feedback has been provided by a wide range of stakeholders, including trial sponsors, CROs, consultants, eTMF vendors and other service and system providers.

Completion of the feedback review is expected around March/April, following which the revised standard will go through a road-test. Any willing vendor or business users who would like to participate in the road-test should contact the exchange team.

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry