OASIS

The latest meeting of the OASIS eTMF Interoperability Technical Committee convened yesterday (3rd March). The main topic on the agenda was signatures and how these should be exported from one system to another. A number of interesting – and perhaps controversial – issues were discussed. The meeting began with an overview presentation of some of the […]

The TMF Reference Model Steering Committee (SC) has been discussing eTMF interoperability in the light of recent announcements from OASIS following the establishment of an eTMF Standard Technical Committee within OASIS. Overall, we are supportive of this initiative, but with caveats as detailed below. The TMF Reference Model provides sponsors and CROs with a reference