Clinical Trials

Protocol Review and Monitoring Committee (PRMC)


Protocol Review and Monitoring System (PRMS) responsibilities required for the Cancer Center Support Grant (CCSG) are carried out by the Sidney Kimmel Cancer Center (SKCC) Protocol Review and Monitoring Committee (PRMC).
For questions, please contact the PRMC Coordinator at 215-955-5426.

PRMC Meeting Schedule and Submission Deadlines - 2022 and 2023

New Study Submissions

All oncology-related studies with no exception must be submitted to PRC for review and approval before IRB submission. E-mail the following documents to PRC@jefferson.edu:
  • Completed New Study Application (aka MCSF)
  • Current protocol
  • Protocol Facilitation Committee Approval Email (if MDG approval is required)
  • Protocol Facilitation Review Form (if MDG approval is required)
  • MDG Priority Score form (if MDG approval is required)
  • Updated MDG disease map diagram that includes this study (if MDG approval is required)
Amendment Submissions

Protocol amendments that affect the principal elements of the original protocol, including but not limited to: study rationale, response criteria, eligibility criteria, objectives, study design, treatment plan, sample size, stopping rules, or statistical plan, must be submitted to PRC for review and approval.When changes in the amendment are not covered under the aspects listed and so, not sure if an amendment needs to be submitted to PRC or not, please contact PRMC coordinator (email: prmc@jefferson.edu).
Note: Amendment submission is not required for NCTN studies and studies sponsored by other NCI designated (or comprehensive) cancer center with our site as a participating site.

For externally sponsored studies, e-mail the following documents to PRMC@jefferson.edu:
  • PRMC Amendment Application Form
  • Summary of changes provided by the sponsor. If no summary of changes is provided by the sponsor, the Principal Investigator (or designee) must create one to be included in the submission.
  • Clean, revised protocol
  • Tracked, revised protocol when provided by the sponsor
For investigator-initiated trials (IITs), e-mail the following documents to PRMC@jefferson.edu:
  • PRMC Amendment Application Form
  • Summary of changes including a reason or justification for each change
  • Clean, revised protocol
  • Tracked, revised protocol
  • If the amendment is in response to a request for revision from a collaborator, the FDA, IRB, or any other regulatory body, a copy of that request for revision should be included
Annual Progress Submissions

All studies, which are applicable to NCI's Data Table 4 (DT 4), are required to submit an Annual Progress Report to the PRMC if it meets the following criteria:
  • approved by the IRB and activation took place at least 6 months ago
  • Suspended studies are not exempt from submitting an Annual Report.

If you are not sure what type of review your study first received or whether an annual progress submission is required or not, please contact PRMC coordinator at prmc@jefferson.edu.

E-mail the following documents to PRMC@jefferson.edu:
  • Completed PRMC Annual Progress Application
  • Current protocol
PRMC Submission Forms
Study PRMC New Study Application (aka MCSF)08/12/2022
PRMC Amendment Application07/20/2022
PRMC Annual Progress Report03/01/2022


PRMC Review Forms (for PRMC Member use only)
New Study Review Form 07/26/2021
New Study Biostat Review Form07/26/2021


PRMC Policies and Procedures
Protocol Review and Monitoring Committee Charter06/01/2022
Accrual Monitoring and Study Closure Policy06/01/2022