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20th Feb 2018, 02:51 PM
#1
Paper TMF - wet ink Protocol Signatures
Still on paper TMF for some studies, and have historically collected 2 original wet ink Protocol Signature pages from the Principal Investigators, one for the ISF and one for the TMF. Is this still necessary? Can we retain the original wet ink in the Investigator Site File and take a copy for the TMF (noting in the TMF that the original is at site), would this cause an issue for our TMF inspections? Or should we make that TMF copy a 'Certified copy', or just continue with 2 wet inks?
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