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What's New

2019

September 18, 2019

  • Updated Study Design Examples: All Example Studies for Results Data Entry, available on the Training Materials page, have now been updated for consistency with the data elements and content in the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). These updated materials also now reflect the current display of study results information on ClinicalTrials.gov. The Parallel Study Design example for results data entry was updated in August 2019.
  • Outdated Content Removed from Support Materials and Training Materials Pages: The ClinicalTrials.gov "Basic Results" Database Helpful Hints document and several videos with outdated content about ClinicalTrials.gov and the Protocol Registration and Results System (PRS) have been removed. This content has been superseded by information available in the PRS Guided Tutorials (BETA).

September 11, 2019

  • Registration is Now Open for the ClinicalTrials.gov Webinar: Updated Quality Control and Posting Procedures: The Training Materials page has been updated with information on how to register for the Tuesday, October 15th webinar.
  • Train-the-Trainer Workshop Application Period Closing September 16: Applications for the November 4-5 Results Database Train-the-Trainer Workshop will no longer be accepted after September 16, 2019. See the Training Materials page for more information on the workshop and how to apply to attend. Another Results Database Train-the-Trainer Workshop is scheduled for May 18-19, 2020, and registration for it will open in 2020.
  • Responsive Design Updates: Several pages have been updated to optimize usability, regardless of screen size or device type.

August 13, 2019

  • New PRS Guided Tutorials (BETA): We have launched a new tool to help Protocol Registration and Results System (PRS) users with entering their results information: PRS Guided Tutorials. The PRS Guided Tutorials are available on the Support Materials and Training Materials pages, as well as in the PRS.

    The tutorials have been launched in beta and we are taking feedback via a survey to help us further develop content and features. Registration content is in development and planned to be added to the tutorials in late 2019.

August 6, 2019

  • Updated Parallel Study Design Example: The Parallel Study Design example for results data entry has been updated to be consistent with the data elements and content in the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), and to reflect the current display of study results information on ClinicalTrials.gov. These materials can be accessed from the Example Studies for Results Data Entry section of the Training Materials page.
  • Registration Now Open for November Train-the-Trainer Workshop: The Training Materials page has been updated with information on how to register for the Nov. 4-5, 2019 Results Database Train-the-Trainer Workshop. The workshop will be held on the NIH campus in Bethesda, MD.
  • New Email Bulletin for PRS Users, ClinicalTrials.gov Hot Off the PRS!: You can now sign up to receive timely email announcements about the Protocol Registration and Results System (PRS), including updates on new features planned for PRS, 42 CFR Part 11 implementation, and resources relevant to PRS users. This bulletin replaces the NIH FDAAA Update listserv, which was discontinued on Aug. 1, 2019.

July 3, 2019

April 11, 2019

March 8, 2019

  • Survey Closed: Our survey to help us better understand site visitor educational needs about clinical studies and research participation has closed (see the Feb. 15, 2019, What's New entry for background). We thank those who took the time to participate.

February 15, 2019

  • Help Us Enhance Our Content: We want to provide easy-to-understand information that helps our website visitors identify important considerations about taking part in clinical studies. To do this, we have launched a survey to help us better understand what our visitors want to know about clinical studies and research participation.

    We are specifically looking to enhance our Learn About Clinical Studies page, and the survey is also available there.

    This project is being done with Health Literacy Media (HLM), a Missouri-based nonprofit organization with health literacy expertise.

    We will update the What's New page when we make changes to our content. If you choose to participate in this survey, thank you!
  • Study Records Now Link to RoPR: Some patient registries that are registered in ClinicalTrials.gov may also be available with additional information in the Agency for Healthcare Research and Quality (AHRQ) Registry of Patient Registries (RoPR). When available, ClinicalTrials.gov patient registry study records now include a link to their RoPR record, shown as a resource link provided by the National Library of Medicine.
  • Study Document Details Added to XML: Study record XML now includes information about any study documents (study protocol, statistical analysis plan, and informed consent form) that have been added to a record. See the XML schema for more details.

2018

December 11, 2018

November 7, 2018

  • Expanded Access Protocol Registration Template Available: The Expanded Access Protocol Registration Template is intended to help investigators understand and gather the data needed to complete each registration module for an expanded access record. The template displays this information in a non-fillable Portable Document Format (PDF) file. (The template cannot be used to submit data directly to the Protocol Registration and Results System (PRS).) For a description of each data element, see the Expanded Access Data Element Definitions.
  • Results Display Changes: The design and display of study results have been modified to enhance functionality and usability.

September 24, 2018

August 2, 2018

  • Observational Study Protocol Registration Template Available: The Observational Study Protocol Registration Template is intended to help investigators understand and gather the data needed to complete each registration module for an observational study. The template displays this information in a non-fillable Portable Document Format (PDF) file. (The template cannot be used to submit data directly to the Protocol Registration and Results System (PRS).) For a description of each data element, see the Protocol Registration Data Element Definitions.
  • Clarification Added to Voluntary Submission Flowchart and Triggered Trials Checklist: Clarifying text has been added to the Voluntary Submission Flowchart and Triggered Trials Checklist to indicate the flowchart should not be used for the purpose of evaluating whether a study is an applicable clinical trial. The flowchart is only intended to help responsible parties determine whether a specific study is a voluntary submission under Section 402(j)(4)(A) of the PHS Act and 42 CFR 11.60.

July 25, 2018

  • New Search Results Display Option: A new option, Sort studies by, has been added to the Advanced Search page. This option allows studies on the Search Results page to be listed either by Relevance or Newest First.

July 6, 2018

June 27, 2018

May 31, 2018

  • Expanded Access Information Enhancements: Expanded access records now include a link that allows users to find associated records for clinical trials of the expanded access intervention/treatment, when available. Options to search and filter by expanded access type (e.g., "Individual Patients" have also been added to the Advanced Search and Search Results pages. Additionally, expanded access type is now displayed under the Study Type column on the Search Results page.
  • BMJ Article for Researchers Using ClinicalTrials.gov: Researchers are increasingly using information from ClinicalTrials.gov to assess clinical research reporting practices or to characterize the clinical research enterprise. A recently published research methods and reporting article by ClinicalTrials.gov staff members discusses 10 key issues to help researchers use the database and consider the scientific appropriateness of their designs/methods. This and other publications by ClinicalTrials.gov staff are available on the Selected Publications page.

May 11, 2018

  • Archive Site Enhancements: The ClinicalTrials.gov archive has been redesigned to incorporate changes described in the December 18, 2017 What's New entry.
  • Search for Study Documents: The Advanced Search page now allows users to search for study records that include any of the following study document types: study protocol, statistical analysis plan (SAP), and informed consent form (ICF). Filters were also added to the Search Results page to allow users to narrow results to study records that include a study document. An optional "Study Documents" column on the Search Results List displays what documents are available.
  • Canceled Submission Added: A new field was added to the Submitted Results tab to indicate when a study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown.
  • Results Submitted and Results Returned Dates Available in XML: The dates for Results first submitted and Results returned after quality control review were added to the study record XML. See the XML schema for details.

April 17, 2018

March 22, 2018

  • Trends, Charts, and Maps Page: The calculations for the Number of Registered Studies Over Time and the Number of Registered Studies with Results Posted Over Time have been revised to use the First Posted and Results First Posted dates (instead of the First Submitted and Results First Submitted dates), respectively. This change allows for clearer representation of the information posted publicly each year and to-date.
  • Information on International Committee of Medical Journal Editors (ICMJE) and World Health Organization (WHO) Policies: The International Committee of Medical Journal Editors (ICMJE) and World Health Organization (WHO) have issued revised versions of policies and information related to clinical trial registration and results disclosure. The Why Should I Register and Submit Results? and the International Policies section of the Support Materials page have been updated for consistency with these revisions.
  • New FAQ on the Final Rule (42 CFR Part 11) Update Requirements: A new Frequently Asked Question (FAQ) was added to the Registration Information and Submission Deadlines section to describe when updates are required to clinical trial information: When must I update clinical trial registration information?
  • Statistical Analysis Template: A new Statistical Analysis template is available from the Data Element Definitions, Templates, and Checklists section of the Support Materials page. This template summarizes the data elements for submitting information about a statistical analysis for an outcome measure as described in the Results Data Element Definitions document and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).

January 25, 2018

Release of New Interventional Study Protocol Registration Template and Updated Results Data Preparation Checklists

The Interventional Study Registration Template is designed to help investigators prepare for registering a clinical trial. It provides a graphical display of the information needed to register a trial in a non-fillable Portable Document Format (PDF) file. (The template cannot be used to submit data directly to the Protocol Registration and Results System (PRS).) Required and optional data elements, including menu options, are grouped by registration module. These modules generally mirror the on-line data entry forms in the PRS. For a description of each data element, see the Protocol Registration Data Element Definitions document.

The Results Data Preparation Checklists were updated to be consistent with the data elements described in the Results Data Element Definitions document and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). The template and checklists can be accessed from the Data Element Definitions, Templates, and Checklists section of the Support Materials page.

2017

What's New and Release of Beta Archive Site (December 18, 2017)

The What's New page was added to describe selected updated features available on the ClinicalTrials.gov Web site.

The ClinicalTrials.gov archive allows users to review previously "posted" versions of a study record to track changes and updates to the study record over the research life cycle. A beta version of the archive is available for testing and feedback. This version of the archive has been redesigned to improve usability and contains a new feature that allows users to view changes between any two versions of a record in either a "merged" view for registration and results information (similar to the Track Changes feature in MS Word) or a "side-by-side" view for registration information. To view the beta archive site, click on the History of Changes link near the bottom of a study record (More Information section). On the History of Changes and the ClinicalTrials.gov Archive Site page, click on the Beta Archive Site link near the bottom. We welcome your comments, questions, and suggestions. To contact us, please click on "Customer Support" in the footer which will take you to the NLM Customer Support page. Then click on "Contact NLM" at the top of the NLM Customer Support page.

Wolf K, Yu A, Ide N, Williams RJ, Tse T. ClinicalTrials.gov: Further Enhancements to Functionality (Full Text). NLM Tech Bull. 2017 Nov-Dec;(419);e9.

Tse T. New ClinicalTrials.gov Beta Version Available for Public Testing (Full Text). NLM Tech Bull. 2017 Nov-Dec;(419);e3.

Wolf K, Ide N, Koufopoulos J. ClinicalTrials.gov: More Changes to Improve Usability (Full Text) NLM Tech Bull. 2017 Sep-Oct;(418):e7.

Wolf K, Ide N, Koufopoulos J, Williams RJ, Tse T. ClinicalTrials.gov: First in a Series of Changes to Improve Usability for Stakeholders (Full Text). NLM Tech Bull. 2017 May-June;(416):e4.

Tse T. Beta Version of ClinicalTrials.gov Available for Testing (Full Text) NLM Tech Bull. 2017 Jan-Feb;(414):e4.

Archive

Huston M, Williams RJ, Bergeris A, Fun J, Tse T. New style and new content for ClinicalTrials.gov (Full Text). NLM Tech Bull. 2012 Jul-Aug;(387):e5.

Tse T, Williams RJ. ClinicalTrials.gov to include basic results data (Full Text). NLM Tech Bull. 2008 Sep-Oct;(364):e15.

Williams RJ, Tse T. New look for ClinicalTrials.gov (Full Text). NLM Tech Bull. 2007 Sep-Oct;(358):e2.

Ripple A, Tse T, Zarin DA. ClinicalTrials.gov scope expanded (Full Text). NLM Tech Bull. 2005 Jul-Aug;(345):e6.

Tse T, Johnson SO, Ripple A. Update: Expanded ClinicalTrials.gov search capabilities (Full Text). NLM Tech Bull. 2002 Jul-Aug;(327):e5.

Tse T. Searching ClinicalTrials.gov (Full Text). NLM Tech Bull. 2000 Sep-Oct;(316):e1.

This page last reviewed in August 2019