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


In section 6.2, it talks about electronic and digital signature. So what kind of information should be captured by signature? Person, reason, datetime stamp?

And if so, how to represent those information in the xml format for data exchange especially for electronic signature?

 

Yan Chen | Engineering Manager

NextDocs 

Phone: +14842571266 | Fax: 610.265.9478 | Email:ychen@nextdocs.com  | Web: www.nextdocs.com

Description: Description: ND Global Alliance Partner SIG



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