University of Vermont

The University of Vermont Cancer Center

submission_investigator

Investigator Initiated Protocols

IRB submission requirements (PDF)

Initial Protocol Submission

Amendments

Non-Administrative Changes: must be reviewed at the monthly PRC full committee meeting.

  • Cover letter with rationale for non-editorial amendments (7 copies)
  • Amendment cover form (7 copies)
  • Tracked changes consent and/or protocol (7 copies)
  • Clean consent and/or protocol (1 copy)

For Administrative Changes: can be reviewed at a weekly PRC Administrative meeting.

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 to the PRC for their monthly meeting:

  • Protocol-related problems and deviations (3 copies)
  • Local report for serious and non-serious adverse events (3 copies)
  • Investigator Drug Brochure Updates (tracked copy if available) and Summary of Changes (3 copies)
  • Batched Safety Reports with table of safety report (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 PRC / 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: Amendment cover 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 December 05 2014 11:45 AM