We have discontinued use of the Budget Request Form and no longer require PDF estimates with PI signature.
STEP 1: Contact the Office of Clinical Trials Activation and complete the OCTA Intake Form for a new study or amendment to study.
- OCTA Intake Form
- If your study does not require OCTA intake for activation or you need more information, submit an inquiry form for next steps
STEP 2: Inform your OCTA team [OnCore, Coverage Analysis, Budget] that CRS services will be included for your study.
Once you have informed your OCTA team that CRS services will be included for your study, you can proceed to the next step. NOTE: If your study does not require OCTA services for budgeting, please complete the CTSI Study Onboarding and Inquiry Request Form.
Special Notes on Application Process
- Veterans Affairs Health Care System: 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 on study application (Section 6.5). For studies that plan to utilize both nursing services and sample processing: After the study is IRB approved, please complete the inquiry form as the first step for using CRS Services and request a preliminary service summary.&
For studies ONLY utilizing CRS sample processing please wait until the speedtype/award is finalized and then complete the inquiry form.
STEP 4: CRS Science Review Requirement
Effective January 1, 2025, Clinical Research Services updated department guidelines regarding the scientific review process.
All studies conducted using the CRS units and services will need to have undergone scientific review. This scientific review requirement can be fulfilled by a review from an external national or state organizations such as:
- US Department of Health and Human Services agencies (NIH, FDA, CDC, ARHQ). For studies that have been reviewed by the FDA. the sponsor will need to provide confirmation of the FDA's review with an OK to Proceed letter or memo verifying the FDA's review for the study's associated IND.
- National Science Foundation (NSF)
- U.S. Department of Defense (DOD)
- U.S. Environmental Protection Agency (EPA)
- Veterans Administration (VA)
- California Institute for Regenerative Medicine (CIRM)
If a study has undergone a scientific review by a state- or national-level organization not on this list, the review can be submitted to CRS to determine if it meets the requirements for external scientific review. At a minimum, the review needs to assess the rationale, study design, and statistical analysis plan of the study.
If a study has not undergone external scientific review, then the study will need to undergo scientific review conducted by CRS. Examples of types of studies that may require CRS scientific review include investigator-initiated studies not funded by a grant or pharmaceutical industry-supported studies that have not had FDA review.
Contact [email protected] with additional questions regarding the CRS science review requirements.
STEP 5: Obtain IRB approval
Once you receive the IRB approval for your study, you can proceed to the next step.
STEP 6: Contact CRS Protocol Services to schedule a study start-up meeting
Submit MD Orders for nursing feasibility assessment
Please provide MD Orders for all visits that will be performed at the CRS clinic. CRS can provide the templates used by the specific clinic if requested. The site nurse manager will review the MD orders and the Protocol/Schedule of Events and ask any necessary clarifying questions.
In Service with CRS Clinic
Once the study is close to completing or has already completed contract execution we can schedule the in-service/start up meeting with the CRS clinic. The CRS budget team will need the speedtype to complete a finalized service summary (also based off the MD Orders provided). The speedtype is also required to request a ZZ Account Number (required for studies at CRS Parnassus and PCRC – not ZSFG or the VA)
Contact [email protected] with any additional questions.