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In a clinical trial, is it acceptable for a Principal

Customer Question

In a clinical trial, is it acceptable for a Principal Investigator to override an ECG reading done by the machine by crossing out an incorrect reading then initial and dating it? We have always done this and it is now being called into question by a CRA. Please advise.
Submitted: 7 months ago.
Category: Legal
Expert:  Briarcliff767 replied 7 months ago.
Hi, my name is ***** ***** I am happy to assist you. Yes this is allowed to be done. But only allowed to be completed by the Principal Investigator. Below is a document from the FDA from a company that asked the same thing and received approval and guidelines. http://www.transceleratebiopharmainc.com/wp-content/uploads/2014/09/Form-FDA-1572-Guidance-for-Completion.pdf
Customer: replied 7 months ago.

Hi Hope, this is for a 1572 form, which comes with it's own set of specific instructions from the FDA. We were specifically looking for the ability to override an ECG reading from a machine. We have always done that with an initial and date and it is oddly being called into question by a Sponsor. I just wanted some back up from FDA guidelines where PIs can edit source to be accurate.

Do you have anything like that?

Expert:  Briarcliff767 replied 7 months ago.

Hi, Yes there is but it is in their handbooks that are given out prior to training. And this link here shows that they are not allowed to white out, erase or obstruct any reports but are allowed to cross out and date and sign incorrect information on readings or reports. http://www.fda.gov/downloads/training/clinicalinvestigatortrainingcourse/ucm378565.pdf