Special requirements pertain to industry sponsors as follows:
- Funding: Physicians who receive direct funding from industry sponsors are a party to the contract.
Fraser Health permits physicians to be paid directly by the sponsor if they choose to hold payments in their own corporation.
- Insurance Certificates: Insurance certificates must reflect the insurance provisions stipulated in the CTA, otherwise the sponsor will be asked to revise the insurance certificate.
- The completion of W8-Ben forms for clinical trials regulated by the United States Food and Drug Administration is the responsibility of the Fraser Health clinical trial site.
Overhead Payments from Industry Sponsors:
- All industry sponsored studies are required to pay an annual institutional overhead fee of 10% to the Department of Evaluation and Research Services for active studies.
- An exception is for any active studies that were approved by the FH Research Ethics Board prior to December 9th, 2010. These studies are required to pay an annual institutional overhead fee of 7%.
- The amount of this overhead is based on the revenue collected by the FH site for their submitted case report forms.
- The Department of Evaluation and Research Services submits an invoice to the FH principal investigator at the time of annual ethics renewal in order to collect the overhead.