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Role and responsibilities of the sponsor 

Role and responsibilities of the sponsor
Chapter:
Role and responsibilities of the sponsor
DOI:
10.1093/med/9780199608478.003.0012
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date: 03 April 2020

This chapter discusses the definitions of a clinical trial sponsor and the roles and responsibilities that it comprises. The aim is to give an overall picture of the role and legal responsibilities and to focus on the systems required for successfully undertaking the role of sponsor. The sponsor is critical, as without a sponsor, a study may not proceed. Sponsor responsibilities are very broad, encompassing overall responsibility for many different trial related activities. These are detailed in GCP guidelines, the EU Directives, the EU Regulation and national regulations. Key areas include authorisations/approvals (including indemnity, insurance and compensation arrangements), financing of the study, conduct of the study to GCP standards, provision of quality systems including SOPs and auditing, manufacture and provision of investigational medicinal product and safety information. Sponsors will therefore require systems to cover these key areas. While activities may be delegated, the sponsor retains overall responsibility, so adequate oversight is required to ensure that these activities are completed to appropriate standards.

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