Is your trial design rigorous? Are your outcomes feasible? Does your protocol meet all regulatory requirements? Have you included start-up time and expenses in your budget?
Planning for Success
The start-up stage of a clinical trial or human subjects study is critical to its success. Our CRSP team is composed of trained, certified, experienced research nurses, non-nurse coordinators, and regulatory and data personnel to help you get up and running, streamlining time-to-activation (TTA).
Feasibility
CRSP can help you determine the feasibility of your trial's staffing, facility, and equipment needs as well as timelines and budget. To prepare for a CRSP feasibility review, we suggest investigators and their research teams read our feasibility FAQ and questionnaire.
For other types of feasibility support (hypothesis testing, cohort estimation/study power analysis, and cohort identification), visit our Research Commons.
Regulatory Requirements
CRSP can help you navigate the IRB process (including SMART IRB for multisite studies), prepare initial Office of Sponsored Programs (OSP) submissions and IND/IDE applications for FDA drug and device trials, and register on ClinicalTrials.gov. Learn more
Budget Preparation & Contract Negotiation:
Whether an investigator-initiated protocol or one that is industry-sponsored, CRSP can help you prepare a successful budget and negotiate a favorable contract. Learn more
Fees
Access a list of CRSP fees here (BlazerID & login required).
Register
To register for a CRSP service, please complete the CBR-CCTS-OCS Submission Form.
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