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26th Jul 2017, 02:27 PM
#1
Keeping Originals / wet-ink with eTMF.
I have to make a company discussion on whether or not to keep original documents and/or wet ink signatures. Following documents are collected as wet ink originals. They were scanned and uploaded in the eTMF . Do we still keep these original wet ink documents ? Concerns include MHRA requirements. Any suggestions will be appreciated.
1) FDA Form 1572
2) Protocol and Amendment Signature Pages
3) Financial Disclosure Forms
4) Investigator Brochure Acknowledgement Signature Page
5) Case Report Forms and DCFs.
Thanks in Advance
Shah Ashraf
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