University of Vermont

The University of Vermont Cancer Center


Investigator Initiated Protocols

IRB submission requirements (PDF)

Initial Protocol Submission


Scientific (Non-Administrative) Changes: must be reviewed at the monthly PRMC full committee meeting.

  • Cover letter with rationale for non-editorial amendments (9 copies)
  • Amendment cover form (9 copies)
  • Tracked changes consent and/or protocol (9 copies)
  • Clean consent and/or protocol (1 copy)

For Administrative Changes:

Call Emily Harwood at (802) 656-2967 if you need assistance determining if an amendment is administrative or non-administrative.

Safety Information

The following types of safety reports must be submitted:

  • Protocol-related problems and deviations (3 copies)
  • Local report for serious and non-serious adverse events (3 copies)
  • Data safety and monitoring report or progress report (3 copies)

Quarterly Reports

As part of the University of Vermont Cancer Center's data monitoring process, all investigator-initiated protocols must submit Quarterly Reports to the University of Vermont Cancer Center. The purpose of this reporting is to ensure and document that the progress of a protocol and the protocol data are being reviewed by the PI and the Safety Officer on a regular basis.

Study Closures

Closures for all studies must be reported to the University of Vermont Cancer Center PRMC / Clinical Trials Office twice: once when the protocol is closed to accrual, and then again when the protocol is closed permanently.

Closed to Accrual: Amendment cover form– Submit one copy when the protocol is closed to accrual (i.e., no longer enrolling patients onto the protocol, but patients may still be receiving treatment, follow-ups, or data analysis per protocol)

Closed Permanently: Continuing Review form AND Final study report – Submit one copy when the protocol is completely closed (i.e., patients are no longer being accrued, treated, or followed)


Last modified June 25 2015 02:10 PM