New Study Submissions All oncology-related studies with no exception must be submitted to PRMC for review and approval before IRB submission. E-mail the following documents to PRMC@jefferson.edu:
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:
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:
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:
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PRMC Submission Forms
PRMC Review Forms (for PRMC Member use only)
PRMC Policies and Procedures
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