Initiating the Clinical Trial Submission Process
As soon as it appears likely that UCR will participate in a clinical trial, please process and route an Electronic Campus Approval Form (eCAF) through to Sponsored Programs Administration (SPA) with the following proposal documents attached:
- Clinical Study PI Questionnaire
- Request for Exception to Principal Investigator Eligibility form , if required
- Form 700-U (State of California's PI/co-PI Statement of Economic Interests), if the study sponsor is a non-governmental entity. Note: The original completed Form 700-U should be forwarded to Office of Research and Economic Development.
- Statement of Economic Interests Supplemental Information Form (submit this Addendum if the Form 700-U is positive)
- Federal Disclosure of Financial Interests Related to Sponsored Projects Form, if the study sponsor is a governmental entity (e.g., NIH funded study)
- Clinical Trial Protocol
- Draft Clinical Trial Agreement (CTA), if provided by sponsor (or contract research organization, referred to as "CRO")
- Draft CTA Study Budget
- Draft Subcontract Study Budget
The above documents are required prior to the negotiation of the CTA with the study sponsor (or CRO). The review of the proposal and negotiation of the CTA requires time and, therefore, should not be left to the last minute. While SPA can proceed with the negotiation and execution of the CTA prior to IRB approval, the Notice of Award cannot be processed until all regulatory approvals are in place (e.g., IRB approval of the protocol, informed consent, and HIPAA Authorization form). Therefore, the PI and study team are encouraged to proceed with other required pre-trial activities (e.g., finalizing the study budget, obtaining IRB approval, etc.) simultaneous to SPA's negotiation of the CTA to prevent undue delays.