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Support Materials

Contents

Protocol Registration System (PRS) Information

Data Element Definitions

Protocol Data Element Definitions. Details on the registration data items (required and optional) that are entered via PRS

Basic Results Data Element Definitions. Details on the results data items (required and optional) that are entered via PRS

Simple Results Templates. Single page formatted summary of the relevant data elements for each results module. The templates are primarily intended to help investigators understand and gather the data needed to complete each module.

Review Criteria and Other Support Materials

ClinicalTrials.gov Protocol Review Criteria (PDF) document. Describes review criteria for study records submitted to the registry (Draft, August 2010)

ClinicalTrials.gov Results Review Criteria (PDF) document. Describes review criteria for each scientific module in the results section of the study record submitted to the results database (Draft, September 2009)

Results Pre-Submission Checklist (PDF). Abbreviated overview of review criteria for avoiding common data entry errors made during results submission (Draft, May 2011)

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.

Common Errors (DRAFT) (PDF). An overview of common errors identified in submitted records with results.

Registering and Reporting Results with ClinicalTrials.gov (PDF). Tri-fold brochure providing an overview of key information on registering and submitting the results of clinical trials to ClinicalTrials.gov.

U.S. Laws, Regulations, and Guidance

Food and Drug Administration Amendments Act of 2007 (PDF). Full text of the Food and Drug Administration Amendments Act (FDAAA); Section 801 of FDAAA (PDF) expanded the requirements for the ClinicalTrials.gov database (September 2007)

Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF). The National Institutes of Health's (NIH) interpretation of the terms "responsible party" and "applicable clinical trial," as used in FDAAA (Draft, March 2009)

What NIH Grantees Need to Know About FDAAA. Information for NIH applicants and grantees about registering a study and submitting results, provided by the NIH Office of Extramural Research

FDA Regulation on Informed Consent Elements. Requirements that informed consent documents and processes for "applicable clinical trials" include a specific statement that clinical trial information will be available on http://www.ClinicalTrials.gov. For more information, see the FDA Questions and Answers on Informed Consent Elements (PDF), 21 CFR § 50.25(c) (February 2012).

Certification of Compliance to FDA, Form FDA 3674 (PDF), which must accompany drug, biological product, and device applications or submissions. For more information, see FDA Guidance on Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions (March 2012).

U.S. Department of Health and Human Services Fall 2013 Unified Agenda - Clinical Trials Registration and Results Submission (RIN:0925-AA55). Describes the public process for the expansion of ClinicalTrials.gov under Section 801 of FDAAA (Fall 2013)

  • EO 12866 Regulatory Review. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA) received the Notice of Proposed Rulemaking (NPRM) on 3/11/2014 for regulatory review. For more information on the regulatory review process, see OIRA Questions and Answers.

CMS Medicare 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) , effective January 1, 2014. For more information, see Details for Transmittal #R2758CP: Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims .

Food and Drug Administration Modernization Act of 1997. Full text of the Food and Drug Administration Modernization Act (FDAMA); Section 113 of FDAMA mandated the creation of a clinical trials database. (January 1997)

International Policies

International Committee of Medical Journal Editors (ICMJE)

Clinical Trial Registration. Part of the ICMJE Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (" ICMJE Recommendations "), 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, as a condition of consideration for publication.

World Health Organization (WHO)

International Clinical Trials Registry Platform (ICTRP). WHO 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 the development of specific criteria for primary registries in the WHO Registry Network.

  • WHO 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.
  • ICTRP Search Portal. Provides a single point of access to studies registered in various international registries, including data available on ClinicalTrials.gov.
This page last reviewed in March 2014