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- Protocol Registration and Results System (PRS) Information
- U.S. Laws, Regulations, and Guidance
- NIH Draft Policy on Registration and Results Submission of NIH-Funded Trials
- Food and Drug Administration Amendments Act of 2007 (FDAAA)
- National Cancer Institute (NCI) Clinical Trial Access Policy
- Center for Medicare and Medicaid Services (CMS)
- Food and Drug Administration Modernization Act of 1997 (FDAMA)
- International Policies
Protocol Registration and Results System (PRS) Information
Protocol Data Element Definitions: Describes the registration data items (required and optional) that are entered via PRS
Basic Results Data Element Definitions: Describes the results data items (required and optional) that are entered via PRS
Simple Results Templates and Results Data Preparation Checklists: Templates are a single-page formatted summary of the relevant data elements for each results module and the checklists provide an overview of the data needed. The templates and checklists are intended to help investigators understand and gather the data needed to complete each results module.
Review Criteria and Other Support Materials
ClinicalTrials.gov Protocol Review Criteria (PDF): Describes review criteria for study records submitted to the registry (Draft, August 2010)
ClinicalTrials.gov Results Review Criteria (PDF): Describes review criteria for each scientific module in the results section of the study record submitted to the results database (Draft, September 2009)
Helpful Hints (PDF): Tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic accuracy studies), and measure types (Draft, September 2009)
Registering and Reporting Results with ClinicalTrials.gov (PDF): Trifold brochure providing an overview of key information on registering and submitting the results of clinical trials on ClinicalTrials.gov (November 2009)
U.S. Laws, Regulations, and Guidance
NIH Draft Policy on Registration and Results Submission of NIH-Funded Trials
The US National Institutes of Health (NIH) proposed a policy to ensure that every clinical trial that receives NIH dollars is registered on ClinicalTrials.gov and has summary results submitted and posted in a timely manner. For additional information on the NIH Draft Policy, see History, Policies, and Laws on ClinicalTrials.gov.
- NIH: Request for Public Comments on the Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information (November 2014)
Food and Drug Administration Amendments Act of 2007 (FDAAA)
Section 801 of FDAAA (PDF) expanded the requirements for submitting clinical trial information to the ClinicalTrials.gov database. The US Department of Health and Human Services (HHS) subsequently issued a notice of proposed rulemaking (NPRM) describing the proposed procedures for registering and submitting the results, including adverse events, of clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. The NPRM does not change the current requirements; instead it is a proposal that is being issued for public comment to inform any future changes to requirements that will be implemented in a final rule. For additional information on the FDAAA 801 NPRM, see History, Policies, and Laws on ClinicalTrials.gov.
- National Institutes of Health (NIH): Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF): NIH's interpretation of the terms Responsible Party and Applicable Clinical Trial, as used in FDAAA (Draft, March 2009)
- NIH Office of Extramural Research: What NIH Grantees Need to Know About FDAAA: Information for NIH applicants and grantees about registering a study, submitting results, and certifying compliance in NIH grants and progress reports.
- Food and Drug Administration (FDA): FDA's Role: ClinicalTrials.gov Information: Information about the certification form required to accompany certain applications/submissions to FDA and the statement required to be included in informed consent regarding the availability of clinical trial information on ClinicalTrials.gov for Applicable Clinical Trials.
- Office of the Federal Register: Clinical Trials Registration and Results Submission Notice of Proposed Rulemaking (November 2014)
U.S. Department of Health and Human Services Spring 2014 Unified Agenda - Clinical Trials Registration and Results Submission (RIN:0925-AA55):
Describes the public process for the expansion of ClinicalTrials.gov under FDAAA 801 (Spring 2014)
- Office of Management and Budget (OMB): EO 12866 Regulatory Review: OMB's Office of Information and Regulatory Affairs (OIRA) received the Notice of Proposed Rulemaking (NPRM) on March 11, 2014, for regulatory review and concluded its review on August 29, 2014. See OIRA Questions and Answers for more information on the regulatory review process.
National Cancer Institute (NCI) Clinical Trial Access Policy
NCI issued its Policy Ensuring Public Availability of Results from NCI-supported Clinical Trials. NCI expects Final Trial Results for all NCI-supported Covered Trials to be reported in a publicly accessible manner within twelve (12) months of the Trial's Primary Completion Date.
Center for Medicare and Medicaid Services (CMS)
CMS issued a National Coverage Determination (NCD) for Routine Costs in Clinical Trials, Section 310.1 (July 2007). Claims for routine costs of qualifying clinical trials as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials covered by Medicare will require health care providers and suppliers to report a ClinicalTrials.gov Identifier (NCT Number).
- CMS: Further Information on Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims (January 2014).
Food and Drug Administration Modernization Act of 1997 (FDAMA)
Section 113 of FDAMA mandated the creation of a clinical trials database to register clinical trials of investigational drugs for "serious or life-threating diseases and conditions" (November 1997).
- FDA Final Guidance: Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF) (March 2002)
- FDA Draft Guidance: Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF) (January 2004)
International Committee of Medical Journal Editors (ICMJE)
ICMJE Issued a Clinical Trial Registration policy as part of the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals , which is followed by more than 1,000 journals. The ICMJE Recommendations encourage journal editors to require that all clinical trials be entered in a public registry before the start of participant enrollment in order for the trials to be considered for publication.
- WHO (ICMJE) - ClinicalTrials.gov Cross Reference (PDF): Table mapping the WHO Trial Registration Data Set, required by the ICMJE registration policy, to the corresponding data elements in ClinicalTrials.gov
- ICMJE: Frequently Asked Questions About Trial Registration
- ICMJE: Journals Following the ICMJE Recommendations: A list of journals that have contacted ICMJE to request listing as a journal that follows the ICMJE's Recommendations
World Health Organization (WHO)
The WHO International Clinical Trials Registry Platform (ICTRP): policy specifies that "the registration of all interventional trials is a scientific, ethical and moral responsibility." Accordingly, the ICTRP provides a global forum for trial registries to share best practices and promotes the development of specific criteria for primary registries in the WHO Registry Network.
- WHO ICTRP: Trial Registration Data Set: Describes the minimum amount of trial information that must appear in a clinical study registry in order for a given trial to be considered fully registered by the WHO
- WHO: ICTRP Search Portal: Provides a single point of access to studies registered in various international registries, including data available on ClinicalTrials.gov