Clinical Trials: Informed Consent Template | Practical Law

Clinical Trials: Informed Consent Template | Practical Law

An informed consent template for FDA-regulated clinical trial concerning investigational drugs being conducted under an investigational new drug application (IND). It covers the FDA-required elements of informed consent and follows common industry standards. This Standard Document has integrated notes with important explanations and tips.

Clinical Trials: Informed Consent Template

Practical Law Standard Document w-004-1750 (Approx. 20 pages)

Clinical Trials: Informed Consent Template

by Practical Law Health Care
MaintainedUSA (National/Federal)
An informed consent template for FDA-regulated clinical trial concerning investigational drugs being conducted under an investigational new drug application (IND). It covers the FDA-required elements of informed consent and follows common industry standards. This Standard Document has integrated notes with important explanations and tips.