- STEP 1: Contact the Office of Clinical Research at ClinicalTrials@ucsf.edu to initiate a Coverage Analysis review for your study
- STEP 2: Complete and submit CRS Budget Request Form
- STEP 3: Submit IRB application via iRIS
- STEP 4: Sign and return your CRS Budget Estimate
- STEP 5: Obtain CRS Scientific Advisory Committee Approval
- STEP 6: Obtain IRB approval
- STEP 7: Follow the steps listed on the CRS Protocol Start-up Instructions
- STEP 8: Contact CRS Protocol Services at CRSProtocolServices@ucsf.edu to schedule a study start-up meeting
- Questions? Contact CRS Protocols Manager
- Frequently Asked Questions
- Forms for new and active studies
STEP 1: Contact the Office of Clinical Research to initiate a Coverage Analysis review for your study
STEP 2: Complete and submit CRS Budget Request Form
- CRS Budget Request Form (Word doc)
- Include your completed Coverage Analysis with the CRS Budget Request Form
- Email Budget Form and Coverage Analysis to email@example.com
Special Notes on Application Process
- 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 IRB and CTSI-AC Approval.
STEP 3: Submit IRB application via iRIS
Indicate study will utilize CRS services. Submission will be routed to CRS for scientific review prior to IRB review. Be sure to upload all relevant documents, including sponsor protocol, informed consent, lab manual, and coverage analysis.
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.
STEP 4: Sign and return your CRS Budget Estimate
- The CRS will provide you with a budget estimate for your study within 10 business days after receiving your completed application.
- Sign and return the CRS Budget Estimate to firstname.lastname@example.org.
STEP 5: Obtain CRS Scientific Advisory Committee Approval
The principal investigator is expected to attend the Scientific Advisory Committee 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. Protocols that have already received scientific review from another source (ex. Cancer Center, NIH) do not need to be presented.
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 IRB, however a final CRS approval will not be granted until IRB approval has been confirmed.
For meeting dates and times per location, please contact CRSprotocolservices@ucsf.edu.
STEP 6: Obtain IRB approval
STEP 7: Follow the steps listed on the CRS Protocol Start-up Instructions
Follow CRS Protocol Instructions.
STEP 8: Contact CRS Protocol Services to schedule a study start-up meeting