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?
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