Item 5b: Name and contact information for the trial sponsor.
“Trial Sponsor: University of Nottingham
Sponsor’s Reference: RIS 8024 . . .
Contact name: Mr PC
Address: King’s Meadow Campus . . .
Telephone: . . .
Email: . . .” 50
The sponsor can be defined as the individual, company, institution, or organisation assuming overall responsibility for the initiation and management of the trial, and is not necessarily the main funder.51;52 In general, the company is the sponsor in industry-initiated trials, while the funding agency or institution of the principal investigator is often the sponsor for investigator-initiated trials. For some investigator initiated trials, the principal investigator can be considered to be a ‘sponsor-investigator’ who assumes both sponsor and investigator roles.51;53
Identification of the trial sponsor provides transparency and accountability. The protocol should identify the name, contact information, and if applicable, the regulatory agency identifying number of the sponsor.
|5a: Contributorship||5c: Sponsor and funder|