News

OASIS eTMF Interoperability Committee Discusses Digital Signatures

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 […]

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TMF Reference Model (TMF RM) Steering Committee Statement on the OASIS Interoparability Initiative

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

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Highlights of the 2012 Metrics Survey

An overview of the 2012 metrics survey has recently been made available. The data indicates a significant growth in the number of organizations transitioning to eTMF.  32% of survey respondents maintain inspectable TMF’s in paper, down from 50% in the corresponding 2010 survey.  While there is only a modest increase in the number of respondents maintaining inspectable electronic

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