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Submitting a Proposal

Refer to the Appendices for a flow diagram for investigator-initiated studies. Investigators wishing to initiate a clinical trial (non-therapeutic or therapeutic) must submit a written document describing the study concept. This submission should be done through Velos; for assistance, send an email request . Preferably the concept will be endorsed by a mentor if the investigator is associated with an organ-site-specific program prior to submission. The concept proposal should be in a two-page format that covers: hypothesis; clinical relevance; patient population; brief description of methods; estimate of statistics (How many patients will you need and how will they be analyzed?).

The Protocol Development Group provides support to investigators in all aspects of governmental and institutional regulatory affairs. The following services are offered for investigator-initiated trials only: developing a complete protocol from a concept submission to the IRB, responses to PRC concerns, IND applications, initial submissions to other regulatory bodies including BSC and RSC, and full IRB maintenance of the trial for life. Contact: Tanya Kocian.

Protocol Review Committee
The PRC reviews protocols primarily for their scientific questions, validity of study design, and biostatistical methods. As part of NCI designation, the Cancer Center and its PRC are mandated to provide a qualified review of all clinical trials involving UCSF patients with cancer or individuals without a diagnosis of cancer but at risk for it. All cancer-related protocols need PRC review. The CHR will pull a protocol from its agenda if the protocol has been disapproved by the PRC, and it will not issue full approval until the protocol has received PRC approval. For appropriate submission flow, please click here.

Types of Review
Studies in these categories may be exempt or eligible for an expedited review by the PRC chair, a process that takes approximately two weeks:

• Cooperative-group trials
• Observational, retrospective, registry, database, or tissue-banking trials
• Trials that do not involve any intervention (drugs, treatments, devices, and behavioral or nutritional strategies, and sometimes surveys as well)
• Amendments for previously approved protocols (i.e., all modifications that go to CHR need PRC review as well)

All other studies are 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). Investigators who are unsure of whether a protocol needs review, or what type of review it requires, may email a copy to prc@cc.ucsf.edu, asking for a determination.

Submission Materials and Deadlines
See the PRC Meeting Schedule for submission deadlines in advance of PRC meetings. Protocols generally need to be received nine business days prior to the full committee meeting. For questions, call (415) 353-9532.

Expedited or Exempt Review
For each of the following items, send one hard copy to UCSF Box 1297 and one electronic copy to prc@cc.ucsf.edu:

• PRC Application Form approved and signed by the appropriate Site Committee leader. For questions, check with the appropriate administrator or contact the core at prc@cc.ucsf.edu or (415) 353-9512.
• Current full-length, master protocol (CHR protocol summary or grant application is unacceptable)
• Current consent form
• All questionnaires/surveys/tools
• Investigator's brochure, if applicable
• Any other supporting documents (e.g., letters of support), if applicable.

Full Committee Review
Full committee applications must be submitted through Velos.

• If you are new to Velos or have not yet received log-on information, complete and submit a Request for Access to Sensitive Data form.
• For instructions on how to apply, or to schedule Velos training for submission purposes only, please send email.