Clinical Cancer Investigations Committee (CCIC) 2010

1. Clinical Cancer Investigations Committee (CCIC) 2010 Reviewer Training Chair: David Gaffney, MD, PhD Vice Chair: Leigh Neumayer, MD

2. Charge of Committee: Review scientific integrity and monitor progress of all cancer-related studies at the University of Utah

3. Clinical Cancer Investigations Committee Goals and Objectives • Scientific merit • Cancer Center priority • Consents reflecting protocols • Patient and facility resources • MDG priority • Approve or disapprove

4. Evaluate protocols for the following criteria: MDG support No competition with open trials Justified background and scientific rationale Clearly stated, achievable objectives and endpoints Appropriate trial design Appropriate risk-benefit ratio Adequate Study Procedures and Stopping Rules in place Adequate DSM plan in place Clearly outlined Adverse Event and Serious Adverse Event Reporting requirements Defined radiology parameters Appropriate biostatisticial plan Appropriate drug administration and utilization Resource allocation assessment

5. CCIC Pre-Meeting Review Process • Pre-Board Preparation • Reviewer Assignments • Minutes Check • Scientific Review • Revision Requests • ERICA Review • (pre-board) • Review Presentation • Review Summary

6. Pre-Board Preparation Check assignments immediately for conflicts. If a conflict of interest is discovered with an assigned study, contact the CCIC program coordinators (Tiffany or Jessica). Review studies as soon as possible after receipt. If major questions arise during pre-review, work with study PI and sub-Is to resolve before meeting. Consult the CCIC program coordinators and fellow CCIC members to resolve concerns.

7. Reviewer Assignments • Note the number of assignments on the agenda. • Questions? Notify the CCIC program coordinator. • Look over the agenda and note any trials from your department or specialty. Do you have points to add to discussion of those items?

8. Minutes Check • Review minutes from previous meeting • Carefully check minutes from reviewed studies, with special attention to discussion comments with specific issues • Notify the CCIC program coordinators of errors in minutes before the meeting • Mention suggested minutes revisions at beginning of next full CCIC meeting

9. Scientific Review • Read CCIC application first in ERICA • Read full protocol and any supporting materials • Consent Review • Consent review only applicable for investigator-initiated or institutional protocols. • The Primary Reviewers and the Patient Advocate (Sadie Quinn) will conduct a thorough review. • Consents can be made available for industry-sponsored trials upon request.

10. Review Summary Write a review summary of the full protocol in ERICA.Include the following: Briefly summarize the strengths and weaknesses of the protocol. Explain any concerns you may have and WHY they are of concern. You must be specific. List specific concerns in a 1., 2., 3. format.

11. Pre-Board Revision Requests Points to Consider: • Will the requested change improve the protocol design? • If a problem with this study has been identified, does the revision suggest a solution? • Has the PI been contacted before or during the meeting to find a resolution of the issue? • Has the revision’s wording been considered carefully? Must means required. Should means recommended or suggested. • The process is compromised when CCIC defers protocols for minor wordsmithing issues.

12. Revision Requests (continued) Specify location of change in document by section and page number. Suggest specific replacement text, if possible. Don’t focus on typos or formatting unless errors are significant, persistent, or change the meaning of the document. The final letter to the PI will contain summarized comments from the CCIC meeting discussion and your written review questions.

13. Reviewer presentations • Two Primary Reviewers • Limit summary to two to three minutes. • Be precise about required changes. • End presentation with a vote recommendation. • Ancillary Reviewers • Limit summary to two to three minutes. • Be precise about required changes.

14. New Voting Options Protocol • Abstain • Conflict of interest • Insufficient information to make informed decision • PI or Co-PI on study • Approve • Defer study, with CCIC administrative review prior to approval • Defer study, with full committee review prior to approval • Disapprove study

15. Reviewer Due Dates • Initial Review • The reviewer checklist is due the morning of the CCIC meeting. • Be sure to hit the Submit Finalized Review button in ERICA. • Subsequent Reviews • Please review PI responses to requested revisions within 24 hours of receipt via email. • Please help us keep the review process moving.

16. CCIC Monthly Meeting

17. CCIC Monthly Meeting • A place to make decisions, not to gather initial information • Before the meeting, get questions answered and discuss with the PI as needed. (This can be done through the program coordinator if anonymity is desired) • Collegial interactions facilitate the review process and promote respect for CCIC. • Attendance • Attendance is required at the monthly CCIC meeting. • All absences must be excused before the meeting. • Quorum is required for the entire meeting. Please don’t leave early.

21. Amendments – CCIC approval required prior to IRB review Increased Risk • CCIC Chair or Vice-Chair and Clinical Research Nurse review and approve amendments. • CCIC Chair or Vice-Chair presents specific concerns verbally in the CCIC meeting. • Minutes summarize and document increased risks. No Change in Risk • CCIC Chair or Vice-Chair reviews and gives administrative approval, provided that the following are not affected: • patient risk • scientific quality • feasibility of the study

23. CCIC Process for Continuing Review • The CCIC initially reviews protocols for accrual progress six months after opening to accrual. Subsequent accrual progress reviews occur annually, based on date of opening to accrual (not date of IRB approval). New trials must enroll a minimum of 3 pts. per year or 50% of their target which ever is greater. • CCIC Chair / Vice-Chair evaluate Continuing Reviews prior to the full CCIC meeting and provide recommendations for action. • The committee votes on the recommendations.

24. Continuing Review Voting Options • CCIC Actions • Approval of Continuing Review • Approval of Continuing Review because of rare disease • Six-month warning letter • 30-day accrual justification letter • Closure to accrual due to under accrual (average one closed protocol per month)

25. CCIC Future Goals