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Support Materials

This page will no longer by updated but will remain available here for historic purposes until the classic site is retired. Please visit Clinical Trial Reporting Requirements on the modernized website for the most recent information.

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.

Plain Language Checklist for Lay Brief Summaries: The checklist lists plain language best practices to help investigators write Brief Summaries that can be easily understood by the general public

PRS Guided Tutorials

The PRS Guided Tutorials provide step-by-step instructions for registering a study, uploading study documents, and submitting results information into the ClinicalTrials.gov PRS. The tutorials also include Quick Overview Guides, a PDF library, annotated figures for various study design examples, and answers to common questions. [Requires a browser that supports HTML5.]

If you would like to provide feedback to help us further develop content and features for the PRS Guided Tutorials, please take our survey.

PRS User's Guide, Review Criteria, and Major Comments List

PRS User's Guide: Describes how to use the PRS to manage accounts, maintain records, and submit clinical study information to ClinicalTrials.gov, including step-by-step instructions for PRS functions.

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)

Major Comments List: Contains the complete list of major comments that may be provided to the responsible party by National Library of Medicine staff during the quality control review. This list is updated as major comments are added or retired from use.

Plain Language Support

Plain Language Checklist for Lay Brief Summaries

Template for Brief Summary

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.

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.

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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)
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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.

NIH Scientific Data Sharing Policies

NIH has a number of data sharing policies that require making available to the public the results of different types of research it supports and conducts, including publications and scientific data. Sharing data enables reuse, increases transparency, and facilitates reproducibility of research results. To find out where to get help with data sharing and stay up to date on NIH data sharing policy-related statements, news, and events, visit NIH Scientific Data Sharing Website. (April 2022)

NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research

For NIH-funded research meeting the definitions of an applicable clinical trial and an NIH-defined Phase III clinical trial, NIH requires reporting of results of valid analyses by sex/gender and race/ethnicity in ClinicalTrials.gov. This policy implements provisions in the 21st Century Cures Act (Public Law 115-255), enacted on December 13, 2016. For more information and examples on how to register outcome measures and report results for an analysis by sex/gender and race/ethnicity, see Guidance for reporting valid analysis as required by the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (NOT-OD-18-014) (PDF).

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.

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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: 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
This page last reviewed in November 2023