Columns 1 and 2 should be identical for the first approval period of the study.  The first approval period will be one year, unless the study has been granted a three-year approval period under the FLEX intiatives. 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the study should be equal to the number of subjects who enrolled, minus those who screen failed, withdrew, were withdrawn, or who have not completed the study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.

Total number of participants approved for the study

40

 

Total since 

LAST approval

Cumulative total since INITIAL approval

Number of subjects enrolled (consented to participation)

25

25

Number of subjects who screen failed

“0” if the study has no screening procedures

   1

   1

Number of enrolled subjects who withdrew

   0

   0

Number of enrolled subjects withdrawn by the PI

   0

   0

Number of enrolled subjects who have not yet completed the study

−   1

   1

Number of enrolled subjects who have completed the study

=   23

=   23

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.

Total number of participants approved for the study

40

 

Total since

LAST approval

Cumulative total since INITIAL approval

Number of subjects enrolled (consented to participation)

10

35

Number of subjects who screen failed

“0” if the study has no screening procedures

   0

   1

Number of enrolled subjects who withdrew

   0

   0

Number of enrolled subjects withdrawn by the PI

−   0

   0

Number of enrolled subjects who have not yet completed the study

−   2

   2

Number of enrolled subjects who have completed the study

=   9

=   32

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)

Total number of participants approved for the study

40

 

Total since

LAST approval

Cumulative total since INITIAL approval

Number of subjects enrolled (consented to participation)

0

35

Number of subjects who screen failed

“0” if the study has no screening procedures

   0

   1

Number of enrolled subjects who withdrew

   0

   0

Number of enrolled subjects withdrawn by the PI

−   0

   0

Number of enrolled subjects who have not yet completed the study

−   0

   0

Number of enrolled subjects who have completed the study

=   2

=   34

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.