OFFICE OF CLINICAL TRIALS (OCTA) FEE

As of Friday August 1st 2008, industry-initiated and industry sponsored clinical trial agreements processed by the Office of Clinical Trials Administration (OCTA) will be charged a non-refundable one time fee of $1,500.00.

  • Fee Required
  • Industry-Initiated and Industry Sponsored
  • Exempt from Fee
  • Investigator-Initiated and Industry Sponsored
  • Industry-Initiated and Funded by a Federally Supported Research Center (e.g. CTSC)
  • Funded by a Private Foundation or Federal Grant

How to Process the OCTA Fee

    Industry-Initiated and Industry Sponsored Trials:
  • The investigator or his/her designee develops and negotiates the budget (normally) but now adds an additional line item for a "non-refundable OCTA fee" of $1500.
    • Your Contract Specialist will add language in the "Payment" or "Compensation" section of your contract clinical trial agreement (CTA) which addresses the mandatory $1500 OCTA fee.
    All other OCTA processes remain the same:
  • The negotiated budget must be provided to your contract specialist in order to fully execute the Clinical Trial Agreement as it becomes part of the final contract.
  • All checks will continue to be routed through OCTA. The investigator will continue to receive scanned copies of the checks and the accompanying receipt transmittal forms (RTFs) detailing how the funds were disbursed.

Rationale for Fee

Should the sponsor of a clinical trial inquire as why there is a set-up fee, it should be explained that the fee is necessary for the operation of the Weill Cornell Office of Clinical Trials (OCTA) which includes the oversight of clinical trial contracts, aspects of research compliance and research finance.

    Specifically the set-up fee offsets costs for:
  1. Contract Negotiations
  2. Monitoring that all regulatory and institutional documents are at hand
  3. Biostatistical and bioethics support
  4. Initial invoicing and accounts receivable
  5. Maintenance of a clinical trial management system
  6. Working with NYPH to negotiate technical research rates as well as the centralized billing and accounts payable department for NYPH services
  7. Conducting feasibility meetings and one-on-one trainings for clinical research staff
  8. Reviewing contracts to ensure WCMC is being appropriately compensated for mandatory fees and is compliant with applicable institutional and legal requirements
  9. Quality control to support compliance with regulatory and industry standards
  10. Reporting for senior level Weill Cornell administration

Please Note: This set-up fee is independent of any department administrative start up fee that may be currently required.

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