University of Vermont

The University of Vermont Cancer Center

submission_cooperative

NCTN and Other Peer-Reviewed Trials*

IRB submission requirements (PDF)

Initial Protocol Submission

 

*If your protocol is eligible for NCI Central IRB (CIRB) review, then the following need to be submitted to the PRMC:

Initial Protocol Submission (eligible for CIRB)

 

Amendments

Amendments that substantially change the scientific design or affect the use of UVM Cancer Center resources and/or funding need to be submitted to the PRMC. Please contact Emily Harwood at 656-2967 if you have questions.

 

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)

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 29 2015 11:16 AM