Clinical Research Services Guidelines & Application Process

Get Started:

• STEP 1: Complete CRS Application Documents
• STEP 2: Send your CRS Protocol Application
• STEP 3: Obtain CRS Advisory Committee Approval
• Questions? Contact CRS Protocols Manager
• Frequently Asked Questions
• Forms for new and active studies

Step 1: Complete CRS Application Documents

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

• CRS 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" industry-sponsored 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. [ Get Form ]
• Veterans Affairs Medical Center: Investigators seeking to conduct research within the VA CRS 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
• CRS information available on the forms page

Back to top

Step 2: Send your CRS Protocol Application

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

Applications Recipients : CRS Protocols Managers

Back to top

Step 3: Obtain CRS Advisory Committee 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 CRS 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.

Early application submission is encouraged to allow for scientific / biostatistical reviews as well as space use and resource evaluation by the Core Managers. Applications can be submitted simultaneously with the CHR, however a final CRS approval will not be granted until CHR approval has been confirmed.

For meeting dates and times per location, please contact Leslie Mullin

Back to top