All cancer studies involving human subjects must pass through a Cancer Clinical Research Pre-Review Approval Process before they can begin. This process is separate from the IRB approval process, but it may take place at the same time.
The approval process is split into two parts: approval by the relevant Disease Oriented Committee (DOC) and approval by the Protocol Review and Monitoring Committee (PRMC). All studies must be approved by their DOC before they are submitted to the PRMC.
DOC Approval
Each DOC has their own submission and approval process and timeline, though they will, generally, meet at least once each month. A list of cancer DOCs, their chairs, and their meeting schedules is listed below. Please contact the appropriate DOC chair to begin the approval process for your study. Additionally, if you need any help regarding DOC approval, please contact the Clinical Trials Office.
| DOC Group | Chair | DOC Meeting |
| Brain (Neuro) | Analiz Rodriguez, MD | Ad hoc |
| Breast | Ronda S. Henry-Tillman, MD | Last Wednesday of the Month 7 AM |
| Cutaneous | Sajjad Bhatti, MD | 1st and 3rd Mondays of the Month at 12 PM |
| Gastrointestinal (GI) | Rangaswamy Govindarajan, MD | Last Wednesday of the Month at 5 PM CI Strauss Room/Zoom |
| Genitourinary (GU) | Murat Aydin, MD | Last Wednesday of the Month at 5 PM |
| Gynecological (GYN) | Laura B. Huffman MD | 1st Wednesday of the Month at 11 AM |
| Head & Neck | Mauricio A. Moreno, MD | 3rd Wednesday of the Month at 5 PM |
| Leukemia/Lymphoma | Muthu Veeraputhiran, MD | Ad hoc |
| Lung (Thoracic) | Konstantinos Arnaoutakis, MD | Every Thursday at 3:30 PM |
| Myeloma | Frits van Rhee, MD, PhD | 1st Friday of the Month at 8 AM |
| Sarcoma | Rangaswamy Govindarajan, MD | Ad hoc |
PRMC Approval
The PRMC meets monthly on the first Wednesday of each month. Submissions for each meeting are due two weeks prior.
Potential Industry Sponsored and Cooperative Group trials must be submitted through the Clinical Trials Office (CTO). Principal Investigators with potential investigator-initiated studies may submit directly via email to the PRMC; submission assistance from the CTO may be available if needed.
Investigator initiated trials are required to consult with the Cancer Institute’s biostatistics shared resource group before they can be brought before the PRMC. Please contact Nia Indelicato for more information.
Please include the following documents with your submission:
- PI Checklist (via redcap survey)
- Please complete the survey and then download a copy of your responses; attach that to the submission email.
- Protocol
- Informed Consent
- Any other relevant documents (investigator brochure, etc.)
For more information about the PRMC, please visit the Protocol Review and Monitoring Committee Page.
Timeline for Approvals
The specific timeline for the process is dependent on DOC and PRMC scheduling. Generally, it can take up to 10 weeks to obtain both DOC and PRMC approval.
For Clinical Trials related questions, please contact Beth Scanlan.
For Protocol Review and Monitoring Committee Questions, please contact Nia Indelicato.