Protocol Review & Monitoring Committee

DOWNLOADABLE FORMS

Biostatistician Letter of Support

DOWG Letter of Support

Initial Submission Form

Routing Sheet – PRMC Full Review

Routing Sheet – PRMC Expedited Review

Letter of Intent

THE PRMC REQUIRES THE FOLLOWING DOCUMENTS:

1.) Completed Initial PRMC Submission Form

2.) Completed Routing Sheet

a. A completed routing sheet will be submitted with all protocol or Letter of Intent (LOI) submissions. Any submission NOT including a completed routing sheet will NOT be reviewed by the PRMC.

b. Note that there is a different routing sheet to use for Cooperative Studies.

3.) Letter of Support from Disease-Oriented Working Group (DOWG) Leader

4.) Biostatistician Letter of Support (for Investigator-Initiated Trials Only)

5.) Department Advocacy Letter (in the absence of a specific DOWG Leader)

6.) Protocol and Appendices

7.) Investigator Brochure, if applicable

All submitted protocols must be in final format. No draft protocols or pre-finalized versions will be accepted. LOI submissions will use the CTEP template. Informed consent documents will NOT be reviewed by the PRMC.

All documents must be received by the circulated deadline dates in order to be reviewed at the next scheduled PRMC meeting. Deadlines may vary depending upon whether PRMC Office assistance with document preparation is requested.

In accordance with the implementation of the On-line Collaborative Research Environment (OnCore), protocol registration is required before submitting to PRMC and/or IRB. Currently, protocols are entered by the OnCore Staff. To request protocol registration by the OnCore staff, please complete the “OnCore Protocol Registration” form.