ESSENTIAL SERVICES
COMPANION SERVICES
Office of Clinical Research Fees
- Support and guidance
Beginning January 1, 2024, all industry-sponsored clinical study agreements will be assessed a one-time, non-negotiable OCR Study Initiation Fee as well as CTA Amendment Fees for each amendment to the clinical study agreement that will increase the study’s overall budget.
OCR Study Initiation Fee
Billed upon contract executions
- The OCR Study Initiation Fee supports the administrative start-up costs for reviews conducted on industry-funded protocols by OCR units involved in study activation processes.
CTA Amendment Fee
Billed per occurence
- The CTA Amendment Fee supports the additional administrative cost for review and negotiation of major CTA Amendments (an amendment routed to the OCR and having an impact on the total study budget) along with other updates.