PRS Information: U.S. Public Law 110-85

U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register and report results of certain "applicable clinical trials":

Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation;

Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric postmarket surveillance studies.

"Applicable clinical trials" generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND). For the complete statutory definitions and more detailed information on the agency's current thinking about their meaning, see this pdf document.

May 21, 2008 Federal Register Notice - describes the public process for the expansion of ClinicalTrials.gov under FDAAA 801 (pdf).
Certification of Compliance to FDA - to accompany Drug, Biological Product, and Device applications or submissions
Statement on Pediatric Postmarket Surveillance of Devices - Pediatric postmarket surveillance of devices ordered under section 522 of the Federal Food, Drug and Cosmetic Act must be registered at ClinicalTrials.gov in accordance with the provisions of Section 801 of FDAAA (see NIH Fact Sheet). Please contact register@clinicaltrials.gov to determine the best mechanism for using ClinicalTrials.gov to address this provision.

Data Submission

Investigators or Sponsors who already have PRS accounts should log into the PRS for the latest information. Others who anticipate needing to register studies in ClinicalTrials.gov in accordance with the provisions of Section 801 of FDAAA should request a PRS account using the instructions provided under Account Application Process.

Expanded Registry

Data Element Definitions (DRAFT) - details on the information that is entered via the PRS
NIH Fact Sheet on registration at ClinicalTrials.gov under FDAAA 801
Information from NIH Office of Extramural Research:

"Basic Results" Database

Common errors (pdf) (DRAFT) - overview of common types of errors identified in submitted records with "basic results"
Helpful hints (pdf) - tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic accuracy studies), reporting measure types, including information on reporting outcomes measured with a scale.
"Basic Results" Data Element Definitions (DRAFT) - details on the information that is entered about results via the PRS.
Detailed Review Items (pdf) (DRAFT) - describes items evaluated by the Quality Assurance/Quality Control staff at ClinicalTrials.gov after results have completed high-level review.
Basic Results Provisions - extracted from FDAAA 801.
Delayed Submission of Results - information on submitting certifications or requests for extension
Recorded Presentation (Adobe Flash: 37 minutes) and accompanying slides (pdf)
- Module 1: ClinicalTrials.gov Overview and PL 110-85 Requirements
- Module 2: "Basic Results" Data Entry
- Module 3: Posted Results at ClinicalTrials.gov