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Subject: Comments Electronic Trial Master File (eTMF) Specification Version 1.0


Dear OASIS,

 

I really think this model would benefit from defining detailed use cases.  For example:

 

·         Ongoing / periodic transfer of documents from a CRO to a sponsor

·         Final transfer of documents from a CRO to a sponsor for a completed study

·         Transfer of documents originating at a sponsor to a CRO

·         Export of a final study for archiving in accordance with records management policies

·         Transfer of documents from a regulatory EDMS to an eTMF

·         Upload of site documents (or vendor documents, etc.)

·         Transfer of a paper TMF to an eTMF

·         Transfer of documents from a legacy eTMF to a new eTMF

·         Export of documents to support regulatory publishing

·         Etc.

 

Regards,

Kathie

Kathie Clark | Director, Product Management Twitter  LinkedIn

Description: Description: Wingspan 1

Mobile: +1 610.659.0778 I  Email: kclark@wingspan.com

Website I eTMF Website I eClinical Blog I eClinical News on Twitter

 

 



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