University of Vermont

The University of Vermont Cancer Center

submission_industry

Industry Protocols

IRB submission requirements (PDF)

Initial Protocol Submission

  • PRMC Protocol Checklist (1 hard copy and 1 on the Commons)
  • Common Protocol Cover Form (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)
  • Investigator Brochure for the study drug (if applicable) (1 hard copy and 1 on the Commons)
  • HIPAA Form for patients to sign (1 hard copy and 1 on the Commons)

Amendments

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 emily.harwood@uvm.med.edu.

  • Cover letter with rationale for non-editorial amendments (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.

Safety Information for Industry-Sponsored Protocols

The following types of safety reports must be submitted to the PRMC for their monthly meeting:

Quarterly Reports

As part of the University of Vermont Cancer Center's data monitoring process, all cancer protocols must submit Quarterly Reports to the University of Vermont Cancer Center. The PRMC monitors accrual of all cancer protocols to ensure proper resources are being distributed and that NCI goals will be met.

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 November 23 2015 03:03 PM