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Understanding the Role of a Clinical Investigator [Food and Drugs]
Definition & Meaning
A clinical investigator is an individual who is directly involved in the treatment or evaluation of research subjects in clinical trials. This term also encompasses any identified subinvestigators, as well as the spouse and dependent children of the main investigator. Clinical investigators play a crucial role in ensuring the integrity and safety of clinical research, adhering to regulatory standards set forth by the Food and Drug Administration (FDA).
Table of content
Legal Use & context
The term "clinical investigator" is primarily used in the context of clinical research and trials regulated by the FDA. It is relevant in various legal areas, including health law and regulatory compliance. Clinical investigators must comply with strict guidelines to ensure the ethical treatment of research subjects and the validity of trial results. Users may manage related forms and procedures through resources like US Legal Forms, which provide templates drafted by qualified attorneys.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A doctor conducting a clinical trial for a new medication is considered a clinical investigator. They are responsible for recruiting participants and ensuring adherence to the study protocol.
Example 2: A research nurse assisting the primary investigator in evaluating patient outcomes is also classified as a subinvestigator and must comply with the same regulatory requirements. (hypothetical example)
Relevant laws & statutes
The primary regulation governing clinical investigators is found in Title 21 of the Code of Federal Regulations (CFR), specifically 21 CFR 54, which addresses financial disclosure by clinical investigators. This regulation outlines the obligations of clinical investigators regarding the disclosure of financial interests that may affect the conduct of clinical trials.
Comparison with related terms
Term
Definition
Clinical Investigator
A person directly involved in conducting clinical trials.
Subinvestigator
An individual assisting the clinical investigator in the trial.
Principal Investigator
The lead researcher responsible for the overall conduct of the trial.
Common misunderstandings
What to do if this term applies to you
If you are a clinical investigator or involved in a clinical trial, ensure that you understand your responsibilities regarding participant safety and regulatory compliance. Consider utilizing US Legal Forms for templates that can help you manage necessary documentation effectively. If your situation is complex or you have specific legal questions, seeking professional legal advice is recommended.
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