Human Research Protection Program and Institutional Review Board

Although necessary for the initial risk assessment, the Human Research Protection Program and IRB will no longer track the enrollment numbers over the course of minimal risk studies. The responsibility for ensuring that enrollment numbers are accurately tracked for analysis, reporting, audit, and funding sources, lies with the Principal Investigator.

Columns 1 and 2 should be identical for the first approval period of the study.  For expedited studies and those reviewed by the full board, the first approval period will be no longer than one year. For subsequent approval periods, column 1 should be limited to the subjects enrolled since the approval of the last continuing review application and column two should include all subjects enrolled over the life of the study. The number of subjects who have completed the study should be equal to the number of subjects who enrolled, minus those who screen failed, withdrew, were withdrawn, or who have not completed the study

Examples of Completed Tables for the first three approval periods of a single study:

Approval Period 1: PI indicates that the study is actively enrolling.

Since this is the first approval period of the study, the total since last approval and the cumulative total since initial approval are the same. The number of subjects who enrolled was 25, and you subtract the one participant who screen failed and the one participant who has not yet completed to get the total number who have completed the study (23).

Approval Period 2: PI indicates that the study is closed to enrollment but still has active participants.

In this study, 10 subjects enrolled since the last approval. Although 2 participants who enrolled since the last approval have not yet completed, the participant from the last approal period has now completed the study, so 9 participants completed since the last approval. This brings the cumulative totals to 35 enrolled, 1 screen failed, 2 who haven’t completed, and 32 who have completed.

Approval Period 3: PI indicates that the study is closed to enrollment and in data analysis only)

Although no additional participants enrolled since the last approval, the two participants who did not complete the study have now completed. This brings the cumulative totals to 35 enrolled, 1 screen failed, 34 completed.

If you would like assistance completing the enrollment table, call the HRPP Office at 541-737-8008.