Investigator Initiated Protocols
IRB submission requirements (PDF)
Initial Protocol Submission
- PRC Protocol Cover Form (8 copies)
- Common Protocol Cover Sheet (8 copies)
- Protocol (8 copies)
- Consent Form (8 copies)
- Supporting documents for the protocol (for example: Surveys, Study Diary for the patient) (8 copies)
- Modality Sign-Off Sheet (8 copies)
- HIPAA Authorization Form for patient to sign and HIPAA Authorization Cover Form (2 copies each)
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.
- Amended pages only of consent and protocol (1 copy)
- Amendment cover form (1 copy)
- "Clean" consent and protocol (1 copy)
- Changes in Key Personnel (1 copy)
- Change in Principal Investigator (1 copy)
- Ads/Recruitment material (1 copy)
Call Emily Harwood at (802) 656-2967 if you need assistance determining if an amendment is administrative or non-administrative.
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)
As part of the VCC's data monitoring process, all investigator-initiated protocols must submit Quarterly Reports to the 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.
Closures for all studies must be reported to the VCC PRC / VCC 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 October 23 2013 10:47 AM