Understanding the Role of Sponsor-Investigator [Food and Drugs] in Clinical Research
Definition & Meaning
A sponsor-investigator is an individual who both initiates and conducts a clinical investigation involving an investigational drug. This person is responsible for administering or dispensing the drug under their immediate supervision. The term specifically refers to individuals, excluding organizations or groups. A sponsor-investigator must adhere to the regulatory requirements that apply to both sponsors and investigators in clinical trials.
Legal Use & context
The term sponsor-investigator is primarily used in the context of clinical trials and drug development. It is relevant in various legal areas, including regulatory compliance, healthcare law, and pharmaceutical law. Understanding this term is crucial for individuals involved in clinical research, as it outlines the responsibilities and obligations of those who both sponsor and conduct investigations. Users can manage related processes using legal templates available through resources like US Legal Forms.
Real-world examples
Here are a couple of examples of abatement:
Example 1: A physician who develops a new cancer treatment and conducts a clinical trial at their hospital is acting as a sponsor-investigator. They initiate the study, recruit participants, and oversee the administration of the treatment.
Example 2: A researcher at a university who creates a new drug for diabetes and conducts a trial to test its effectiveness is also a sponsor-investigator, managing all aspects of the study. (hypothetical example)