Definition:

A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyses the data.

The sponsor is also referred to as the applicant. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. According to the US FDA, sponsors are responsible for:

  • Selecting qualified investigators
  • Providing them with the necessary information
  • Ensuring proper monitoring of the investigation
  • Ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the Investigational New Drug (IND)
  • Maintaining an effective IND with respect to the investigations

Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug.

More information:

FDA – Guidance for Clinical Trial Sponsors

FDA – Responsibilities of Sponsors and Investigators

Tags:
Definition, Encyclopaedia, Guideline, Phase 1, Phase 2, Phase 3