Support Materials

Contents

• Protocol Registration System (PRS) Information
  • Data Element Definitions
  • Review Criteria and Other Support Materials
• U.S. Laws, Regulations, and Guidance
• International Policies
  • International Committee of Medical Journal Editors (ICMJE)
  • World Health Organization (WHO)

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 2012 Unified Agenda. Describes the public process for the expansion of ClinicalTrials.gov under Section 801 of FDAAA (Fall 2012)

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)

• FDA Information on FDAMA. Historical perspective on the development of ClinicalTrials.gov, and an overview of FDA's role in supporting the success of the database, and on accessibility of clinical trials information to the public
• FDA Final Guidance, March 2002: Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF)
• FDA Draft Guidance, January 2004: Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF)

International Policies

International Committee of Medical Journal Editors (ICMJE)

Obligation to Register Clinical Trials. Part of the Uniform Requirements for Manuscripts (URM) Submitted to Biomedical Journals established by the ICJME, which is followed by more than 1,000 journals. The URM requires that all clinical trials be entered in a public registry before the start of participant enrollment, as a condition of consideration for publication.

• WHO (ICMJE) - ClinicalTrials.gov Cross Reference (PDF). Table mapping the WHO Trial Registration Data Set, as required by the ICMJE registration policy, to the corresponding data elements in ClinicalTrials.gov.
• ICMJE Frequently Asked Questions About Trial Registration
• Journals Following URM. A list of journals who have contacted ICMJE to request listing as a journal that follows the ICMJE's URM.

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.