QA
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Our CTU currently uses MACRO as our eCRF software (although soon to be using RedCap).
We are querying the process of getting the PI to sign off their site participant data at the end of the study.
Should there be one sign-off at the end of the study by the PI or should they be signing off each individual participant within MACRO? We could add in an electronic sign off for each participant. If we do one at the end, should it be an electronic signature within MACRO, or a wet-ink signature on (perhaps) a file note to certify they are happy with the data, or even a printout of the entire data set (which apparently we can do via the MACRO archiving module)?
All thoughts and experience welcome!
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