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Subject: OASIS


Dear OASIS,

Thank you for progressing this important topic. While I support the definition of a technical (IT) standard to exchange document information, I feel the contextual standard, (e.g.  attributes and naming conventions), should not be part of the standard. Your work should focus on the interface, (e.g. API), which any system can use to exchange information with any other system which supports the API.

 

This approach will provide the most utility as we could then readily transform legacy TMFs to any target that supports the API. This could be used for submitting to different agencies, sponsor mergers, sponsor partnerships, contribution to a ‘universal’ TMF…

 

This also decouples the transport layer from the data itself which provides the best flexibility and ability to change over time.

 

Kind Regards,

Tyler Witko

 

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Tyler Witko
Director, Clinical Trial Master File – Clinical Operations
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT
P: 203 778-7617
tyler.witko@boehringer-ingelheim.com


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