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Support Materials

Contents

Protocol Registration and Results System (PRS) Information

Data Element Definitions, Templates, and Checklists

Data Element Definitions: These documents describe the registration, expanded access, and results data items (required and optional) that are entered via PRS.

Protocol Registration Templates: Each template is a formatted summary of the data elements for each registration module, specific to the relevant study type. The templates are intended to help investigators understand and gather the data needed to complete each registration module.

Simple Results Templates and Results Data Preparation Checklists: The templates are one-page formatted summaries of the relevant data elements for each results module, and the checklists provide an overview of the necessary data. The templates and checklists are intended to help investigators understand and gather the data needed to complete each results module.

PRS User's Guide, Review Criteria, and Other Support Materials

PRS User's Guide: Describes how to use the PRS to submit clinical study information to ClinicalTrials.gov, including step-by-step instructions.

ClinicalTrials.gov Protocol Review Criteria (PDF): Describes review criteria for study records submitted to the registry (June 2018)

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 (June 2018)

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)

U.S. Laws, Regulations, and Guidance

Food and Drug Administration Amendments Act of 2007 (FDAAA) and Final Rule (42 CFR Part 11)

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) was issued by the U.S. Department of Health and Human Services in September 2016. The Final Rule clarifies and expands the regulatory requirements and procedures for submitting registration and summary results information of clinical trials on ClinicalTrials.gov, in accordance with Section 801 of FDAAA (PDF). The regulation is effective on January 18, 2017 and responsible parties were expected to be in compliance as of April 18, 2017. For additional information on the Final Rule for FDAAA 801, see History, Policies, and Laws on ClinicalTrials.gov.

Revised Common Rule (45 CFR Part 46) and Posting of Clinical Trial Consent Forms

A revised Federal Policy for the Protection of Human Subjects (also known as subpart A of 45 CFR part 46, or the "Common Rule") was issued in 2017 and became effective on July 19, 2018. The revised Common Rule (at 45 CFR 46.116(h)) requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form used in enrolling participants be posted on a publicly available Federal website within a specific time frame. In an August 2018 announcement, ClinicalTrials.gov and Regulations.gov were identified as the publicly available federal websites that will satisfy the consent form posting requirement. HHS and other Common Rule departments and agencies are developing instructions and other information about this posting requirement. NOTE: No obligations to post such consent forms apply before January 21, 2019, the general compliance date for 45 CFR Part 46. For additional information on submitting Informed Consent Forms to ClinicalTrials.gov, see Appendix A.1 of the ClinicalTrials.gov Results Data Elements Definitions document.

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 (Issued March 2002; Withdrawn by FDA September 2017)
  • FDA Draft Guidance: Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued January 2004; Withdrawn by FDA September 2017)

Key U.S. Policies

NIH Policy on Registration and Results Submission of NIH-Funded Clinical Trials

The U.S. National Institutes of Health (NIH) issued a final policy establishing the expectation that every clinical trial funded in whole or in part by NIH is registered on ClinicalTrials.gov and has summary results submitted and posted in a timely manner. For additional information on the NIH Policy, see History, Policies, and Laws on ClinicalTrials.gov.

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 12 months of the trial's Primary Completion Date.

Department of Veterans Affairs (VA) Clinical Trial Registration and Results Submission Policy

The VA policy on clinical trial registration and submission of summary results requires principal investigators (PIs) of VA Office of Research and Development (ORD)-funded clinical trials to register their trials and submit summary results to ClinicalTrials.gov as a condition of funding. This policy uses the same definition of clinical trial as the International Committee of Medical Journal Editors and the World Health Organization. PIs must register their VA ORD-funded clinical trial on ClinicalTrials.gov in order for study funds to be distributed. They must also update the study record in a timely manner and submit summary results information within 1 year of the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov).

Center for Medicare and Medicaid Services (CMS) and Reporting of ClinicalTrials.gov Identifiers on Claims

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).

Patient-Centered Outcomes Research Institute (PCORI) Process for Peer Review and Public Release of Results

PCORI adopted a process for peer review and public release of the results of the comparative clinical effectiveness research studies that it funds. This process includes registering and submitting summary results information to ClinicalTrials.gov for relevant clinical trials and observational studies. Patient registries are similarly required to be registered on ClinicalTrials.gov and the Agency for Healthcare Research and Quality's Registry of Patient Registries (RoPR).

Note: Methodological and other projects that are not clinical studies should not be submitted to ClinicalTrials.gov and must instead be registered in the National Library of Medicine Health Services Research Projects in Progress database (HSRProj).

International Policies

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 for the trials to be considered for publication. The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered. In June 2017, ICMJE amended its recommendations (PDF) to include registration of an individual participant data (IPD) sharing statement (see IPD Sharing Statement data element on ClinicalTrials.gov) as an additional consideration for publication of reports for clinical trials that begin enrolling participants on or after January 1, 2019.

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, 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. In addition, the WHO Statement on Public Disclosure of Clinical Trials Results specifies that "[t]here is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past."

  • WHO ICTRP Trial Registration Data Set: Describess 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
This page last reviewed in November 2018