We’ve noticed a few trends on reporting enrollment on study closure forms that we’re hoping to nip in the bud:
— When listing the total number of people who enrolled in your study, please be sure to include everybody who signed a consent form, even if they failed screening or didn’t actually participate in the study for some other reason. We know some sponsors only include those who actually entered the study in their enrollment numbers, but for IRB purposes, if they signed a consent form, they’re enrolled. So please count them all when closing out your study.
— For chart review studies, the total enrolled count should equal the total number of charts from which you collected data. Even though your study didn’t involve any actual humans, it did involve human subjects, as far as the regulations are concerned. So be sure they are listed accurately.