Comments Electronic Trial Master File (eTMF) Specification Version 1.0

["Kathie Clark" <kclark@wingspan.com>]

Dear OASIS,

 

I don’t see any place in the model to transfer information about the trial and sites.  E.g.:

 

Study:

·         Name

·         Description

·         Phase

·         Type

·         Milestones

·         Therapeutic area

·         Status (ongoing, terminated, closed, archived, etc.)

·         Etc.

 

Site:

·         Institution

·         Country

·         Address

·         Status

·         Milestones

·         Etc.

 

Regards,

Kathie

Kathie Clark | Director, Product Management   

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