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Save Money by Keeping Up with Clinical Trial Reporting Regulations

A quick web search can give you millions of websites and articles about nearly every topic under the sun, so it’s no surprise that information on upcoming, existing, and closed clinical trials has found a home on the internet at ClinicalTrials.gov.

ClinicalTrials.gov was originally launched by the NIH National Library of Medicine in February 2000 in response to the 1997 Food and Drug Administration Modernization Act (FDAMA). The site’s original focus was to provide public information on studies that tested experimental drugs for serious or life-threatening conditions.

The FDA initially provided guidance and recommendations for submitting information to theCRA records patient data on a mobile device. site, but it wasn’t until 2007 that Congress passed the Food and Drug Administration Amendments Act Section 801 (FDAA 801) which expanded the types of clinical trials that must be registered in ClinicalTrials.gov, required results reporting, and added enforcement provisions. Penalties for non-compliance include publically recorded penalty notices as well as monetary penalties of up to $10,000 dollars per day and the potential for withholding of NIH grant funds.

Earlier this year, Congress introduced H.R. 6272 which would increase reporting requirements and prompt the FDA to report compliance. The bill was introduced in response to a study in the British Journal of Medicine that found only 22% of trial sponsors reported results within one year of completion. Although the FDA disagrees with the reported findings, one thing is certain – clinical trial sponsors need to know the regulations surrounding reporting on ClinicalTrials.gov or prepare to face non-compliance penalties. The U.S. Department of Health and Human Services  recently transferred responsibility for overseeing the registry and ensuring on-time submission of data to the FDA, so be sure to review applicable regulations.

Here are a few quick facts about registering on ClinicalTrials.gov:

Sponsors or sponsor-designated principal investigators must register applicable trials within 21 days following first patient enrollment and submit trial results within one year of study completion. Registration on ClinicalTrials.gov is currently required for the following types of trials:

-Controlled trials of drugs, biologics, and devices subject to FDA regulation, excluding Phase 1, observational, and feasibility studies

-Trials with one or more U.S. sites

-Trials conducted under an FDA investigational new drug application or investigational device exemption

-Trials involving a drug, biologic, or device manufactured in the U.S.

-Pediatric post market surveillance of devices

For more information contact our experienced clinical operations team or visit the resources listed below.

Resource links: 

FDAAA 801 Requirements

History of ClinicalTrials.gov

FDA Clinical Trial Regulations and Guidance Documents 

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