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THE COMMITTEE ON HUMAN RESEARCH

CANCER CENTER PROTOCOL REVIEW COMMITTEE (CCPRC)

Cancer-Related Applications

All UCSF cancer-related clinical protocols must undergo the following review process in the order listed:

1) Submit new protocols to the applicable program’s Site Committee for review and approval.

A Site Committee has been established for each site-specific research program to enhance integration of laboratory and clinical research and to develop new studies. These committees meet monthly and are chaired by the Program Co-Leader of each site-specific research program. The Site Committee assesses the scientific validity of protocols, prioritization of protocols within the programs and the feasibility of protocols based on the available patient resources.

• List of Site Committees and Chairs

2) Following Site Committee approval, submit new protocols to the Cancer Center’s Protocol Review Committee (PRC).

All application types must be submitted through OnCore. For instructions on how to apply, or to schedule OnCore training for submission purposes only, please send email.

The PRC meets monthly, and concentrates primarily on scientific questions, the validity of the study design, and the biostatistical methods employed. The review outcome may be approved, contingently approved, or disapproved.

Some studies may be exempt or eligible for an expedited review by the PRC chair, a process that takes approximately two weeks. All other studies must be reviewed by the full committee and may take up to six weeks for a response (but no more than three business days from the date of review). Please see the PRC website for more information. Investigators who are unsure of whether a protocol needs review, or what type of review it requires, also may email a copy of the protocol to prc@cc.ucsf.edu, asking for a determination.

Investigators seeking more information on PRC should:

• Visit the PRC website.


• Contact the PRC at prc@cc.ucsf.edu.
  

3) After PRC full approval or contingent approval, submit new protocols to CHR for review and approval.

The CHR will not review a non-peer reviewed cancer-related protocol until the study has undergone PRC review and received either contingent approval or full approval from the PRC. Peer-reviewed cancer-related protocols may be submitted to CHR simultaneously with submission to the PRC. CHR will not issue full approval until the protocol has all contingencies removed and has obtained full PRC approval.

No protocol should be submitted to CHR without prior submission to the PRC.

4) Protocol modifications should also be submitted to the PRC, and may or may not require PRC re-review.

The PRC needs to review all modifications to a protocol once initial approval is obtained.There is a standard application process for all amendments. Please see the current policy for application instructions.