Sponsor

Sponsor is a body that takes responsibility for the planning, initiation, management, and financing of a clinical trial.

Definitions

ICH E6(R2)

1.53 Sponsor:

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. .

CFR

A sponsor is defined in the regulations at 21 CFR 58.3(f), 312.3(b), 510.3(k), 511.3, and 812.3(n) .

Responsibilities of sponsor

The sponsor's primary role is to ensure that the study is conducted in accordance with regulatory requirements and good clinical practice (GCP) guidelines. Main duties of sponsor include:

• developing the study design and plan
• selection and management of investigators and trial sites
• study monitoring
• data management
• reporting and publications

Transfer of sponsor obligations to a CRO

Under U.S. regulation (21 CFR 312.23(a)(1)(viii)), if a sponsor transfers any obligations for the conduct of a clinical study to a contract research organization (CRO), the Investigational New Drug (IND) application must include a statement specifying:

• the name and address of the CRO
• identification of the clinical study to which the transfer applies
• a listing of the sponsor obligations that have been transferred

If all obligations governing the conduct of the study have been transferred, a general statement of full transfer may be submitted in place of a detailed listing .

CRO involvement must therefore be disclosed at the IND level, and transferred responsibilities must be clearly traceable. Transfer of obligations does not relieve the sponsor of ultimate regulatory responsibility for the study.

Sponsor signature and U.S. representative

The IND must be signed by the sponsor or the sponsor’s authorized representative (21 CFR 312.23(a)(1)(ix)). If the sponsor does not reside in the United States and does not have a place of business in the United States, the IND must:

• identify a U.S.-based attorney, agent, or other authorized official, and
• be countersigned by that individual 

This requirement ensures that FDA has a U.S.-based legal and regulatory point of contact for the IND.

Types of sponsors

Under U.S. regulatory

U.S. regulatory framework under the FDA recognize two types of sponsors :

1. regulatory sponsors
2. financial sponsors

A regulatory sponsor is the person or entity responsible for starting and overseeing a clinical investigation. They submit Investigational New Drug (IND) or Investigational Device Exemption (IDE) to the FDA and handle all communications with the agency (21 CFR 812.3(n) ; 21 CFR 312.3(b) ).

A supporting financial sponsor provides funding for the study (21 CFR 54.2(h) ).

Under European Union clinical trials regulation

EU framework does not formally recognize the separation of sponsors into regulatory and financial categories as distinct entities.

In practice, however, the entity responsible for regulatory submissions and communications with regulatory authorities can be different from the entity providing the funding. This practical division of roles is acknowledged and managed within the trial agreements and contracts between the involved parties.

See also

Another relevant pages

• CRO
• Investigator
• Sponsor-Investigator