Item 5b: Name and contact information for the trial sponsor.
Example
“Trial Sponsor: University of Nottingham
Sponsor’s Reference: RIS 8024 . . .
Contact name: Mr PC
Address: King’s Meadow Campus . . .
Telephone: . . .
Email: . . .” 50
Explanation
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 |
