Clinical Trials

Protocol Review Committee (PRC)


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 Committee (PRC).
For questions, please contact the PRC Coordinator at 215-955-5426.

PRC Meeting Schedule and Submission Deadlines - 2019 and 2018

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 PRC coordinator (email: prc@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 PRC@jefferson.edu:
  • PRC 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 PRC@jefferson.edu:
  • PRC 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

Effective November 1, 2016: All studies currently open to accrual or suspended except studies that initially received administrative review / exempt from PRC review are required to submit an annual progress application to the PRC prior to IRB expiration each year until the study is permanently closed to accrual. 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 PRC coordinator at prc@jefferson.edu.

E-mail the following documents to PRC@jefferson.edu:
  • Completed PRC Annual Progress Application
  • Current protocol
PRC Submission Forms
Study PRC New Study Application (aka MCSF)10/05/2018
PRC Amendment Application02/01/2018
PRC Annual Progress Report02/01/2018


PRC Review Forms (for PRC Member use only)
New Study Review Form 11/03/2016
New Study Biostat Review Form11/03/2016


PRC Policies and Procedures
General SOP02/17/2017
Accrual Monitoring and Study Closure Policy05/01/2017