University of Vermont

The University of Vermont Cancer Center

submission_cooperative

NCTN* and Other Peer-Reviewed Trials

Studies that are sponsored by the NCTN must be reviewed by the PRMC. Please submit the following to the PRMC Compliance Specialist, Emily Harwood, at the Courtyard at Given, N403.

Submitting protocols and supporting forms to the PRMC is now available as electronic submission through the UVM Commons. 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 using the Commons to submit protocols electronically.

Additionally, one paper copy of the protocol and forms must be given to Emily Harwood, The Courtyard at Given, N403.

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

For peer-reviewed trials not eligible for NCI Central IRB (CIRB) review, the following need to be submitted to the PRMC:

  • 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)
  • HIPAA Form for patients to sign (1 hard copy and 1 on the Commons)
  • Investigator Drug Brochure for the study drug (if applicable) (1 hard copy and 1 on the Commons)

 

*Initial Protocol Submission (eligible for CIRB)

If your protocol is eligible for NCI Central IRB (CIRB) review, then the following need to be submitted to the PRMC. These must be submitted electronically on the UVM Commons. Please contact Emily at 656-2967 or emily.harwood@med.uvm.edu if you have questions about the UVM Commons.

Additionally, one paper copy must be delivered to the UVMCC Compliance Specialist, Emily Harwood, The Courtyard at Given, N403.

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

 

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 to the PRMC:

  • UVM Medical Center SAFE Report for potentially serious and continuing non-compliance (1 copy via email to emily.harwood@uvm.med.edu )

The following types of safety reports do not require submission to the PRMC:

  • Local Adverse events (not serious)
  • Broadcast SAEs
  • Unanticipated problems (including local SAEs) potentially involving risk to subjects or others

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 August 30 2016 02:55 PM