PRMC submission process (for investigators only)
All cancer-related clinical research proposals must be submitted to the VCU Massey Cancer Center Protocol Review and Monitoring System Committee prior to submission to the Institutional Review Board.
Prior to submitting a protocol, investigators are strongly encouraged to discuss study design and statistical analysis with a member of Massey's Biostatistics Shared Resource Facility. Massey biostatistician input is mandatory for all Massey investigator-initiated studies with therapeutic intervention and supportive care intent.
All Massey investigator initiated trials (IITs) with therapeutic or supportive care intent must also be written using the appropriate MCC clinical protocol template. Two versions of the template are available, one with language that is needed for a clinical protocol being conducted under an FDA IND, and one without the FDA IND language. The templates and additional support material are available from the Protocol Templates page link to the left. Investigators are strongly encouraged to involve the Massey scientific writers in the protocol writing and editing process.
CITI Training is mandatory for all individuals (principal investigators, co/sub-investigators, research nurses, research assistants, clinical research associates, fellows, etc.) who wish to participate in research. Please login here and create an account. Be sure to select Virginia Commonwealth University as your institution. You should take the Biomedical Basic or Refresher course if you are conducting biomedical research with human subjects. Physicians participating in Cancer Prevention and Control research must also complete Social and Behavioral CITI training. Send your completion certificate to firstname.lastname@example.org.
The PRMC requires three documents:
- The protocol
- The informed consent document. Please create your informed consent document based on the consent and assent templates developed by VCU’s Institutional Review Board provided here.
- The Protocol Submission Form [pdf]. Use these instructions [pdf] for completing the Submission Form.
Send a completed PRMC Protocol Submission Form, protocol and informed consent document to the PRMC at masseyPRMS@vcu.edu.
For questions regarding format and other requirements, please contact the PRMC coordinator at (804) 628-8480.