Clinical Research Center Guidelines

Get Started:

• STEP 1: Complete CRC Application Documents
• STEP 2: Send your CRC Protocol Application
• STEP 3: Get the CRC Advisory Committee's Approval
• Questions? Contact CRC protocols Manager

Step 1: Complete CRC Application Documents

The following documents are required before the Advisory Committee Meeting approval process, for all new CRC protocols:

• CRC application [ Get Form ]
• CHR application [ Get Form ] [ Review CHR "How to Apply" Guidelines ]
• Protocol (master, CHR, sponsor, etc.)
• DSMP / DSMB (DSMB roster may be required) [ Get Form ]
• Consent(s)
• Budget (required for all studies)
• Executed Contract (required for all Category "D" studies, between sponsor & UCSF)
• Human Research Protection Training Certificate for Principal Investigator [ Find out how to complete training ]

Special Notes on Application Process

CHORI Hospital

A separate application to the CHRCO Institutional Review Board is required. The CHRCO application form for IRB can be dowloaded here: http://www.chori.org/Clinical_Studies/IRB/IRB_Forms.html

Veterans Affairs Medical Center

Investigators seeking to conduct research within the VA CRC must have protocols approved by the VA R&D committee in addition to CHR and CTSI-AC Approval.

Pre-Protocol Implementation Checklist : Phase I 

• Send Applications to R&D, CHR and CTSI-AC (If the protocol is already CHR and R&D approved, only the CTSI-AC application is required.)
• CHR information available here: http://www.research.ucsf.edu/chr
• CRC information available on the forms page

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Step 2: Send your CRC Protocol Application

Each new protocol application is to be submitted at least two weeks prior to an Advisory Committee Meeting. The CRC Advisory Committee (CAC) reviews protocols for scientific merit, participant safety, statistical power, study design, and budget requests.

Applications Recipients : CRC Protocols Managers

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Step 3: Get the CRC Advisory Committee's Approval

The principal investigator is expected to attend the CAC meeting to present the research proposal. This provides an opportunity to clarify issues and facilitate the review process. If the principal investigator is unable to attend the meeting, another member of the investigative team may present the protocol as long as that individual is familiar with the study and is qualified to address issues of a scientific nature.  The protocol managers are able to assign specific presentation times so the presence of the investigative team isn't required for the complete duration of the meeting.

The presenter will give a brief descriptive summary of the protocol, detailing how the CRC resources will be used. The Chair will then lead an open discussion, starting with the assigned scientific reviewers and biostatistician, followed by questions or concerns from the committee. After this discussion, the investigator will be asked to leave the meeting to allow the committee to complete its review in closed discussion.  Investigators will be informed of the committee's decision (either approval, approval pending response to questions/concerns, or deferral) following the meeting.

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