Following review by the TMF Reference Model Steering Committee, the Charter of the Exchange Mechanism Standard (EMS) subgroup has been finalized and published. The Charter can be downloaded here.
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.