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24th Aug 2012, 04:26 PM
#1
Filing signed informed consent forms in site file
I'm working at investigator site and normally we have "Patient Information Sheet and Consent Form" in one set e.g. patient information sheet starting from page 1 to 14 and then on page 15 is Consent form. Version control is implemented. Is it fine to file only "signed informed consent form" (page 15th) in site file?
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