Roles and responsibilities
Item 3b: Name and contact information for the trial sponsor
Example
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“Sponsor:
University of Oxford
Research Governance, Ethics & Assurance, Joint Research Office
Boundary Brook House
Churchill Drive, Headington,
Oxford, OX3 7GB, United Kingdom
…
EudraCT Number: 2021-004267-27.“(44)
Explanation
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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 funder [45, 46]. In general, the company is the sponsor in industry-initiated trials, while the institution of the primary 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 [46].
Identification of the trial sponsor provides transparency and accountability and can also help to identify conflicts of interest (Item 7b). Reviews of two samples of 108 and 292 trial protocols from 2016 found that 57% and 78% respectively reported the name and contact details of the sponsor [9,10].
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The protocol should identify the name, contact information and, if applicable, the regulatory agency identifying number of the sponsor.
Summary of key elements to address
For the trial sponsor (e.g., individual, company, institution, or organisation):
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Name
-
Contact information
-
Regulatory agency identifying number (if applicable)