IRB Notes: Enrollment questions in the Continuing Review Questionnaire

Continuing review is the ongoing monitoring mechanism by which Institutional Review Boards (IRBs) ensure the continuing protection of subjects who participate in research. The questions below, which are part of the Continuing Review Questionnaire, can be a confusing. Here are some helpful hints to determine who really is considered enrolled in your study.

Question 5.5  Total subjects since study began
In studies dealing with a warm body, this number includes all subjects who signed a consent form – even if that subject did not continue in the study.  If this study enrolls subjects under this IRB number at two different places (i.e. OHSU and the VA), please include the TOTAL number of subjects enrolled here. You’ll use 5.5.4 (described below) to sort out enrollment at each place separately.

If this is a chart review – this would be the number of charts accessed to complete the aim of your study. Even if that review didn’t reveal the info you were looking for,  it still was accessed for purposes of the study. Be sure when you submit a study you consider that you may need to look at a lot to get the data you need so plan your enrollment request accordingly. Refer to question 6 below.

Question 5.5.2  Number of subjects currently participating in the study (i.e. receiving treatment or undergoing procedures, visits, or interventions as applicable, and are not in follow-up or discontinued from the study)
These are the subjects that are still doing or having things done to them that are outlined in the protocol.

Question 5.5.3  Number of subjects currently in follow-up
These are the subjects that have completed all study related procedures, tests, etc. As an example, they may be subjects who you check in with periodically by phone.

Question 5.5.4   Optional Commentary – for complex study designs, please provide any helpful information to help the IRB better understand the current state of enrollment.
This box gives you the opportunity to elaborate on what the numbers above may mean. Included here might be text that describes how many subjects you enrolled at OHSU and a second entry about how many subjects were enrolled at the VA. OR you may include an explanation as to why you enrolled 15 subjects but there are none in treatment (5.5.2) and none in follow-up (5.5.3). It may simply be that the subjects were not able to qualify for the study, they’ve completed the study, they withdrew, or may be deceased.

Question 6  If more subjects have been consented than were approved, please explain.  
This page also includes the number of subjects you were granted approval for at initial review. The numbers you provide above must not go over the approved number but sometimes that does happen. You may have underestimated the number of charts you’d access, the number of screen fails you would have, or it could be an error on our part. In any case, please describe any discrepancy. You’ll be contacted by the managing IRB analyst who will ask for additional information. It is important to disclose the information so that all records are consistent and straight and over enrollment doesn’t occur again.

Please contact Ames Elliot if you have any questions.