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. [1].
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) [2].
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
It is important to note that even though the sponsor might delegate most of its duties to a contract research organization, the responsibility for the study still lies with the study sponsor.
Types of sponsors
Under U.S. regulatory
U.S. regulatory framework under the FDA recognize two types of sponsors [3]:
- regulatory sponsors
- 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) [4]; 21 CFR 312.3(b) [5]).
A supporting financial sponsor provides funding for the study (21 CFR 54.2(h) [6]).
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
Links to this page
- Confidentiality (← links)
- Contract (← links)
- Independent data-monitoring committee (← links)
- Functional Service Provision (← links)
- Request for Proposal (← links)
- Interim Clinical Trial (Study) Report (← links)
- Investigator (← links)
- Protocol (← links)
- Safety (← links)
- Source data (← links)
- Source documents (← links)
- Regulation (EU) No 536/2014 (← links)
- Sponsor-investigator (← links)
- Standard operating procedures (← links)
- Sub-investigator (← links)
- Plain language summary of study results (← links)
- Comparison of IRB and IEC requirements (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
- ↑ FDA Compliance Program 7348.810: Sponsors and CRO, https://www.fda.gov/media/75916/download Accessed Jul 2024
- ↑ UC Davis Clinical and Translational Science Center, 2015, UC Davis Clinical Research Guidebook, page 42
- ↑ 21 CFR 812.3(n), https://www.ecfr.gov/current/title-21/part-812/section-812.3#p-812.3(n) Accessed Jul 2024
- ↑ 21 CFR 312.3 “Sponsor”, https://www.ecfr.gov/current/title-21/part-312/section-312.3#p-312.3(Sponsor) Accessed Jul 2024
- ↑ 21 CFR 54.2(h), https://www.ecfr.gov/current/title-21/part-54#p-54.2(h) Accessed Jul 2024
External links