Clinical Investigation: A Comprehensive Guide to Its Legal Definition

Definition & Meaning

Clinical investigation is a structured study aimed at assessing the safety and effectiveness of a product, such as a drug, medical device, or biological substance, in treating, preventing, or diagnosing a disease or condition. These investigations involve human subjects and are crucial for determining the benefits and risks associated with the product.

These studies are conducted under the oversight of the Food and Drug Administration (FDA) to ensure ethical standards and participant safety. According to 42 USCS § 1320a-7h (e) (3), a clinical investigation includes any experiment involving human subjects or materials derived from them, where a drug or device is administered or used.

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Legal Use & context

Clinical investigations are primarily used in the fields of healthcare and pharmaceuticals. They are essential for the approval process of new treatments and medical devices. Legal aspects surrounding clinical investigations include:

Compliance with FDA regulations.
Informed consent from participants.
Ethical review by Institutional Review Boards (IRBs).

Users may find relevant legal forms on platforms like US Legal Forms to help navigate the documentation and compliance requirements associated with clinical investigations.

Key legal elements

Real-world examples

Here are a couple of examples of abatement:

Example 1: A pharmaceutical company conducts a clinical investigation to test a new cancer drug. They recruit participants who have been diagnosed with cancer and monitor their responses to the treatment.

Example 2: A medical device manufacturer tests a new heart monitor in a clinical investigation to assess its effectiveness and safety in patients with heart conditions. (hypothetical example)

Relevant laws & statutes

Key regulations and statutes related to clinical investigations include:

Federal Food, Drug, and Cosmetic Act (FDCA)
21 CFR Part 312 - Investigational New Drug Application
21 CFR Part 812 - Investigational Device Exemptions

Comparison with related terms

Term	Definition	Key Differences
Clinical Trial	A type of clinical investigation specifically designed to test the efficacy and safety of a treatment.	All clinical trials are clinical investigations, but not all clinical investigations are clinical trials.
Observational Study	A study where researchers observe participants without intervening.	Clinical investigations often involve direct intervention, while observational studies do not.

Common misunderstandings

What to do if this term applies to you

If you are considering participating in a clinical investigation, it's important to:

Understand the purpose and procedures of the study.
Ask questions about the risks and benefits.
Ensure that you provide informed consent before participating.

For those involved in conducting clinical investigations, using legal templates from US Legal Forms can help ensure compliance with necessary regulations. If the process seems complex, seeking professional legal advice is recommended.

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Quick facts

Attribute	Details
Typical Duration	Several months to several years, depending on the study.
Approval Required	FDA and Institutional Review Board (IRB).
Participant Compensation	Varies; some studies offer compensation for time and travel.