FDA Guidance Defines ‘Important’ Protocol Deviations

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

By signing up for a tour of the Thompson FDA Compliance Expert Suite, you are also registering to receive email offers and product updates from us. Simply click unsubscribe at the bottom of any email if you would like to discontinue delivery.

FDA Draft Guidance Defines ‘Important’ Protocol Deviations and Provides Recommendations for Handling Them

J.W. Schomisch

December 29, 2024 at 01:33 PM EST

The FDA issued draft guidance Dec. 27 that was intended to help clarify sponsor and investigator responsibilities for identifying, mitigating and reporting protocol deviations and to provide recommendations to institutional review boards (IRBs) for evaluating protocol deviations. The draft guidance defines important protocol deviations as those “that might significantly affec... Read More

My Research Folders

You are not Logged in yet, Please login to see Your research folders.

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

FDA Draft Guidance Defines ‘Important’ Protocol Deviations and Provides Recommendations for Handling Them

My Research Folders

THOMPSON FDA

COMPLIANCE EXPERT

RESOURCES

HELP

CONTACT