Sponsor-investigator

Sponsor-investigator is an individual who both initiates and conducts a clinical trial, and under whose immediate direction the investigational drug or device is administered or dispensed.

Definitions

ICH E6(R2)

1.54 Sponsor-Investigator:

An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator .

Role

A sponsor-investigator handles the regulatory submissions to the FDA, designs the study, conducts the trial, monitors participant safety, and reports the findings.

Challenges for sponsor-investigators

Managing both sponsor and investigator roles can be demanding in terms of time, resources, and expertise. This role requires a thorough understanding of both clinical and regulatory requirements.

Sponsor-investigator must manage potential conflicts of interest since they are responsible for both the trial conduct and oversight.

Regulatory responsibilities and compliance with regulations

The sponsor-investigator is responsible for submitting the necessary regulatory documents to the FDA, such as the investigational new drug (IND) or investigational device exemption (IDE) applications. A sponsor-investigator must comply with:

• 21 CFR Part 312: for drugs
• 21 CFR Part 812: for devices
• 21 CFR Part 11: for electronic records and signatures
• 21 CFR Part 50: for the protection of patients
• 21 CFR Part 54: for financial disclosure
• 21 CFR Part 56: for Institutional Review Boards (IRBs)

See also

Another relevant pages

• Investigator
• Sponsor