Clinical Trial Site agreements are required for all Clinical Trials involving Investigational Medicinal Products or Devices.
For other research their requirement is at the Sponsor’s request or, occasionally, at the request of the site. Site agreements can cover both activities at the site, financial aspects, material/data transfer but are not the sole mechanism for implementing these agreements.
The University's trials Units have specific arrangements for the generation and approval of site agreements. Anyone else who requires an agreement with a site should contact the Contracts team.
In most cases, for non-interventional studies, the HRA Organisation Information Document will adequately cover the arrangements needed.