Cancer Protocol Committee (CPC) - Progress Report Form eIRB #: Pro Full Protocol Title: Principal Investigator: Date:
SECTION 1: INSTRUCTIONS 1. This form is required for all cancer-related protocols involving prospective enrollment. a. Cooperative Group/NCTN studies and pediatric studies are not required to submit this form. 2. This form must be uploaded into Section 07 Progress Report when the IRB Continuing Renewal application is being submitted. a. At the specific request of the CPC, some protocols may require submission of CPC Progress Reports at a greater frequency.
SECTION 2: PROTOCOL PRIORITIZATION The Protocol Priority should match that provided in the CPC New Protocol Submission Form at the time of initial CPC review.
Protocol Priority Assigned at Initial CPC Review Rate of accrual expected by CPC
High 75% of projected cumulative accrual
Standard 75% of projected cumulative accrual
SECTION 3: PROJECTED VS. ACTUAL ACCRUAL Projected accrual numbers should match those provided in either the CPC New Protocol Submission Form at the time of initial CPC review or revised accrual numbers provided at your most recent annual CPC renewal. All accrual numbers should reflect subjects who are not screen failures
Projected Accrual Max # of subjects to be consented at DUMC Time from IRB Initial Review Date Actual # of subjects who are not screen failures Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7 Yr 8+ Total At DUMC
At non-DUMC sites: (Complete this row only if protocol is Duke PI-initiated and multi-site) Projected accrual timeframe occurs from the period of IRB approval through submission of the continuing renewal to the IRB. The CPC will adjust its evaluation of accrual to account for time between the IRB Initial Review Date and Institutional Approval.
Actual Accrual (see Appendix A for Accrual Expectations) Max # of subjects to be consented at DUMC Time from IRB Initial Review Date Projected # of subjects who are not screen failures Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7 Yr 8+ Total At DUMC
At non-DUMC sites: (Complete this row only if protocol is Duke PI-initiated and multi-site)
PR form, version 11.18.2015 Page 1 of 4 The CPC will adjust its evaluation of accrual to account for time between the IRB Initial Review Date and Institutional Approval.
Institutional Approval Date:
Date that study opened to accrual: Only necessary if the open to accrual date differs from the institutional approval date
Have there been any updates to the primary or study completion dates in clinicaltrials.gov?
SECTION 4: COMPETING STUDIES List all studies that compete for the subject population being recruited for this study.
eIRB # PI Protocol Title
SECTION 5: PI COMMENTS AND/OR REQUESTS
If actual enrollment did not meet projected enrollment, provide answers to the following questions. Please answer thoughtfully and thoroughly; a CPC decision to approve or disapprove this study will be based on the responses below.
1. Has the Clinical Research Group Leader been notified about the low accrual? Yes No If no, please notify the appropriate Clinical Research Group Leader prior to submission of this form. See Appendix B for listing of Clinical Research Group Leaders
2. What is the justification for keeping this study open?
3. What are the reasons for low accrual?
4. What do the PI and Group Leader propose as the corrective action plan to increase accrual?
Other comments or requests. 5. Have any amendments been approved over the past year that changed the IRB max # of consented subjects? Yes No
6. Does the PI wish to submit a request to change protocol priority? Yes No Does the PI wish to adjust the yearly projected accrual rates based upon the prior year’s accrual? Yes No If yes, confirm that the PI has received Group Leader permission to make this request Confirm Please provide rationale for this request:
7. Please provide revised projected accrual rates below:
Max # of subjects to be consented at DUMC Time from IRB Initial Review Date Projected # of subjects who are not screen failures Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7 Yr 8+ Total At DUMC
At non-DUMC sites: (Complete this row only if protocol is Duke PI-initiated and multi-site)
8. Please provide any additional PI comments or requests here:
PR form, version 11.18.2015 Page 2 of 4 PR form, version 11.18.2015 Page 3 of 4 APPENDIX A: CPC ACCRUAL EXPECTATIONS
This table applies only to protocols involving prospective enrollment.
Protocol Type Accrual Benchmark Possible Consequences For Failure To Reach Benchmarks High priority*** 75% of projected cumulative accrual to date First offense: Approval with covenant - PI should carefully reconsider feasibility or devise corrective action plan
Second offense: Approval with covenant - PI should carefully reconsider feasibility or devise corrective action plan
Third offense: Approval with covenant, or Disapproval - PI may appeal but termination still possible Standard Priority*** 75% of projected cumulative accrual to date First offense: Approval with covenant - PI should carefully reconsider feasibility or devise corrective action plan
Second offense: Approval with covenant, or Disapproval - PI may appeal but termination still possible
*** For protocols involving very low projected annual accrual or rare cancer subjects, exceptions to accrual benchmarks and consequences may be allowed on a case-by case basis.
APPENDIX B: Authorized signatories for each Disease Group Please follow the link below to find the appropriate Disease Group Leader and Research Group Statistician. Research Group Signatories
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