OxCRF can provide a range of study site services by agreement with the trial PI and Sponsor. These will be decided via delegation and trial agreements. It offers three basic delegation models:
- Full: All study site operations managed by OxCRF on behalf of the PI. Includes site administration, management of participant visits and follow-up, liaison with monitor/ sponsors and provision of clinical cover.
- Partial: A bespoke agreement by which study site responsibilities are shared between the PI study team and OxCRF.
- Minimal: the PI study team arranges to use OxCRF to perform participant visit procedures and access specialist cover and resources.
Whichever model is agreed, the sponsor is responsible for the selection and oversight of the study site. The PI must retain overall responsibility for the entire conduct of the trial. OxCRF Operational Policy and procedures will apply to any activity delegated or performed within it. These will include assurance that arrangements are feasible.