Investigator Initiated Protocols
Studies that are written by a local PI and involve an intervention for the patient must be vetted by a TDT and then reviewed by the PRMC Full Committee. Please submit the following to the PRMC Compliance Specialist, Emily Harwood, at the Courtyard at Given, N403.
Submission of new protocols must be done by electronic submission through the UVM Commons as well as one paper copy sent via inter-office mail to Emily Harwood, The Courtyard at Given, N403. The link to the PRMC page on the Commons is: https://commons.med.uvm.edu/cp/uvmcc/prmc/default.aspx . Not all research coordinators or PIs currently have access to the Commons. Please contact Emily Harwood at 656-2967 regarding setting up an account in the Commons to submit protocols electronically.
The IRB has separate submission requirements for studies: (PDF) . It is up to the PI and research coordinator to contact the IRB and to submit protocol documents.
Initial Protocol Submission
- TDT Protocol Checklist completed in full and presented to/signed by TDT members of study disease site if applicable (1 hard copy and 1 on the Commons). TDT meetings are listed here.
- Common Protocol Cover Sheet (1 hard copy and 1 on the Commons)
- Protocol (1 hard copy and 1 on the Commons)
- Consent Form (1 hard copy and 1 on the Commons)
- Supporting documents for the protocol (for example: Surveys, Study Diary for the patient) (1 hard copy and 1 on the Commons
- Modality Sign-Off Sheet (1 hard copy and 1 on the Commons)
Please submit all amendments to the PRMC Coordinator. Amendments involving scientific changes will be reviewed at the monthly PRMC Full Committee meeting. Amendments that do not require PRMC review will be filed and the research coordinator will receive an acknowledgement email from the PRMC Coordinator. Documents may be emailed to the PRMC Coordinator, Emily Harwood, at firstname.lastname@example.org.
- Cover letter with rationale for amendment changess (1 hard copy or by email)
- Amendment cover form (1 hard copy or by email)
- Tracked changes consent and/or protocol (1 hard copy or by email)
- Clean consent and/or protocol (1 hard copy or by email)
- Revised Investigator Drug Brochure (if applicable) (1 hard copy or by email)
Call Emily Harwood at (802) 656-2967 if you have questions about submitting the amendment.
The following types of safety reports must be submitted to the PRMC Coordinator:
- Protocol-related problems and deviations (1 copy by email)
- Local report for serious and non-serious adverse events (1 copy by email)
- Data safety and monitoring report or progress report (1 copy by email)
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
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)