ROAD MAP: Getting a Cancer Study Done at Jefferson Meghan Wakefield,RN,CCRP Senior Director of Clinical Trials Office Clinical Research Organization

NCI Guidelines AKA: the CORE Grant As an NCI Designated Cancer Center we are mandated to follow the current NCI guidelines. All cancer trials enrollment need to be registered All status changes in JeffTrial are done through Sophia Hines.

Associate Director of Clinical Research Executive Director Clinical Research Organization Early Drug Development Office Senior Director Phase I Unit EDCTN/Sara Cannon Molecular Targeted Therapies Clinical Trials Office Senior Director GI Malignancies Aero-Digestive Malignancies Hematologic Malignancies Women’s Cancer GU Malignancies Melanoma and Cutaneous Malignancies Solid Tumors Regional Network Office Senior Director Cooperative Groups SKCC Network Affiliates Consortium Partners Other Protocol Support Unit Quality and Process Improvement Unit

The submission process MDG PRC IRB PRC and IRB Simultaneous Amendments New trial

Multi-disciplinary Groups GI Aero-Digestive Hematologic Women’s Cancer GU Melanoma and Cutaneous Malignacies Solid Tumors

Protocol Review Committee (fka: CCRRC) comprises investigators broadly representing basic and clinical sciences that: Reviews scientific integrity of cancer clinical trials Meetings occur the second and fourth Monday of the month Deadlines are two weeks prior to the meeting Reviewers are confidential and there is open communication Cancer trials are not reviewed by IRB without written PRC approval IRB copied on correspondence from PRC to PIs regarding trial closure for compliance or accrual Assures protocol compliance by monitoring accrual

Protocol Review Committee Approval Format: Approved Approved with administrative changes Changes must be made but do not need to come back to PRC Approval with the following recommendations --- optional The PRC will sign off on protocols with no further review and the IRB will be made aware of the recommendations. Changes are not required and do not need to come back to PRC Conditional approval with mandatory stipulation changes The PRC final approval letter will not be sent to the PI until the issues raised here are completed satisfactorily Changes come back to the Administrative Chair for verification of change but do not go back to the full board for approval Disapproved- revisions needed – three strikes rule Disapproved

PRC Amendment review When must an amendment get PRC approval? The amendment changes at least one of the following that would affect scientific merit: a. Inclusion/exclusion criteria b. Objectives c. Statistics d. Subject population How do amendments get submitted to PRC? Send an to: with the below a. Tracked MCSF b. Amended Protocol c. Summary of changes document. 1. MCSF with tracked changes

NCI Guidelines require for NCI designated Cancer Centers accrual monitoring of clinical trials. That responsibility rests with the PRC at the SKCC The PRC will review your trial at 6 months after activation. If your trial is ≤ 30% of expected accrual for the year, the PRC will send you an requesting an explanation of the accrual status. The response is expected within 10 days to the inbox. The response will be reviewed at the next PRC meeting and you will be ed with the outcome. This outcome may include termination of the trial.

Data Safety Monitoring Committee Policy established in collaboration with the NCI in 2011 Meets quarterly Currently oversees 42 IIT clinical trials The DSMC coordinator assigns a Medical Monitor – recommends continuation, suspension, or termination May call for an adhoc meeting to discuss action plans Assign a category of risk to every IIT

In a nutshell….. Call our Clinical Research Organization Office (fka CRMO) the PRC at :