What's New

2023

May 25, 2023

ClinicalTrials.gov Beta Updates: ClinicalTrials.gov Beta has a redesigned disclaimer and a simplified search experience that combines the basic and advanced search features. Please read the latest Release Notes to learn more.
Modernization Public Meeting Recordings Available: Recordings from the April 25, 2023 virtual public meeting have been added to the ClinicalTrials.gov Modernization webpage.

May 11, 2023

Modernization Public Meeting Slides Available: The presentation slides from the April 25, 2023, virtual public meeting have been added to the ClinicalTrials.gov Modernization webpage.
Top Questions and Answers about the Transition to the Modernized ClinicalTrials.gov and the Modernized Protocol Registration and Results System Available: Questions received via the sites' feedback buttons and during events such as the April 25, 2023, modernization public meeting have been answered in Modernization Transition Top Questions (PDF).

May 4, 2023

PRS Beta Updates: Updates to PRS Beta were released to the PRS. The new release includes the protocol registration modules, along with onscreen guidance and updated help content. Read more about these new features in the NLM Technical Bulletin, or read the latest Release Notes to learn more.

April 11, 2023

ClinicalTrials.gov Beta Updates: Several new features have been added to the Record History in ClinicalTrials.gov Beta, notably, the ability to view the details of a single study-record version of an interventional study. Please read the latest Release Notes to learn more.

April 6, 2023

The Journal of the American Medical Association Article on Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type: This study examines the dissemination and timing of trial results by data source (i.e., ClinicalTrials.gov and PubMed) and funder type (i.e., NIH, non-NIH US federal agency, industry, and other). Selected Publications.

March 9, 2023

Virtual Public Meeting on ClinicalTrials.gov Modernization: Join us on April 25, 2023, from 12:30 p.m. to 3 p.m. ET for a detailed look at the current beta websites, progress updates, and an opportunity to hear from the modernization team members and other stakeholders. Please register in advance. The meeting will be recorded, and the recording and presentation slides will be available on the ClinicalTrials.gov Modernization webpage after the meeting.
ClinicalTrials.gov Beta Updates: ClinicalTrials.gov Beta now has a table view of the study record. Please read the latest Release Notes to learn more.

February 8, 2023

Good Cause Extension (GCE) Request Information Available: The Final Rule (42 CFR Part 11) Information page has been updated to include Good Cause Extension Request Process and Criteria. This document explains the process of submitting a good cause extension (GCE) request, the information to be included in GCE requests, and the criteria NIH uses to evaluate GCE requests. As of February 15, 2023, GCE request submissions will be subject to this criteria.
New and Updated FAQs Available to Clarify the Good Cause Extension Request Process and Criteria.
- New FAQs:
  - How does NIH determine whether to grant or deny a good cause extension request submitted under 42 CFR 11.44(e)?
  - What is the process to file an appeal after a good cause extension request for delayed submission of results information has been denied or granted with an earlier deadline than requested?
- Updated related FAQs under the Results Information and Submission Deadlines section linking to Good Cause Extension Request Process and Criteria.

January 31, 2023

ClinicalTrials.gov Beta Updates: ClinicalTrials.gov Beta now includes a new draft design of the application programming interface (API) for additional access to data as well as resources for using the API. Please read the latest Release Notes to learn more.

2022

December 19, 2022

ClinicalTrials.gov Beta Updates: ClinicalTrials.gov Beta now has a streamlined search experience, and study records have a new Record History tab, making it easier to view changes to the record. Please read the latest Release Notes to learn more.
Demonstration Videos Available: Prerecorded demonstration videos presenting features of PRS Beta and ClinicalTrials.gov Beta and highlighting changes from the classic sites are now available.

December 7, 2022

Webinar Materials and Modernization Progress Report Available: The recording and slides of the October 27, 2022, webinar featuring an update on the progress of the modernization effort, demonstrations of the ClinicalTrials.gov Beta and Protocol Registration and Results System (PRS) Beta websites, and a live Q&A have been added to the ClinicalTrials.gov Modernization page. Also available is the Report on the ClinicalTrials.gov Modernization Effort, Summary of Progress: 2021-22, which presents an update on the ClinicalTrials.gov Beta and PRS Beta websites, future modernization activities, and more.

November 17, 2022

ClinicalTrials.gov Beta Updates: ClinicalTrials.gov Beta now has an updated tabular view of search results and new printer-friendly layouts for selected pages. Please read the latest Release Notes to learn more. Explore these new features and use the Give feedback button to let us know what you think.

October 6, 2022

Webinar on ClinicalTrials.gov Modernization and Beta Sites Progress: Join us on October 27, 2022, from 1 to 2 p.m. ET for an update on the progress of the modernization effort and an overview of the Beta ClinicalTrials.gov website and Protocol Registration and Results System (PRS) Beta. Please register in advance. A recording of the webinar will be made available for those who cannot attend the live event.

September 26, 2022

Update to Data Element Definitions, Templates, and Checklists: A Plain Language Checklist for Lay Brief Summaries (PDF) is added to the Support Materials under Data Element Definitions, Templates, and Checklists . The checklist identifies plain language best practices to help investigators write brief summaries that can be easily understood by the general public.

August 23, 2022

ClinicalTrials.gov Beta Updates: ClinicalTrials.gov Beta has a new, improved search for clinical studies and now has a table view for search results. Please read the Release Notes to learn more. Explore these new features and use the Give Feedback button to let us know what you think.
Updated FAQ to Clarify Requirement on Submitting Results for a Non-applicable Clinical Trial: Frequently Asked Questions (FAQs) page has an updated FAQ (Am I required to submit to ClinicalTrials.gov the results of a clinical trial that is not an applicable clinical trial?).

June 15, 2022

British Medical Journal Article on Master Protocol Study Designs on ClinicalTrials.gov: This article describes the approach for reporting master protocol study designs on ClinicalTrials.gov. This and other publications by ClinicalTrials.gov staff are available on the Selected Publications.

June 9, 2022

New FAQ to Clarify the Deadline for Submitting a Good Cause Extension request for Prematurely Terminated Studies: The Frequently Asked Questions (FAQs) page has a new FAQ clarifying the deadline for submitting a good cause extension request for prematurely terminated studies.
How to Register Your Study: This page has updated content regarding Registering Expanded Access Records under Considerations for Observational Studies and Expanded Access Records.

April 7, 2022

New and Updated FAQs to Clarify Expanded Access and All-Cause Mortality: Frequently Asked Questions (FAQs) page has new and updated FAQs on Expanded Access and Submission Deadlines and a new FAQ on reporting All-Cause Mortality as part of clinical trial results information (Which deaths must I submit in the all-cause mortality table as part of clinical trial results information?).
Resource for NIH Data Sharing Policies Added: The Support Materials page has been updated with information on the new NIH Scientific Data Sharing Website.

March 8, 2022

ClinicalTrials.gov Beta Updates: ClinicalTrials.gov Beta contains new features, improvements, and bug fixes. For more details about this release and upcoming releases, see the ClinicalTrials.gov Beta Release Notes Page.

January 19, 2022

New and Updated FAQs to Clarify the Deadline for Submitting Good Cause Extension Requests for Delayed Submission of Results Information: The Frequently Asked Questions (FAQs) page has new and updated content under the Results Information and Submission Deadlines section:
- New FAQ: What is the deadline for submitting a good cause extension request for delayed submission of results information?
- Updated related FAQs to clarify that responsible parties may only submit good cause extension requests for delayed submission of results information prior to the date (i.e., the day before) that results information would otherwise be due.

2021

December 22, 2021

Modernization and Beta Website Webinar Materials Available: A recording of the December 10, 2021 webinar and slides describing the launch of beta ClinicalTrials.gov and demonstration have been added to the ClinicalTrials.gov Modernization page.

December 8, 2021

ClinicalTrials.gov Beta Website Now Available. The first beta release of the ClinicalTrials.gov modernization effort has arrived and can be accessed https://beta.clinicaltrials.gov/. Read more about the new features of the Beta ClinicalTrials.gov site in the NLM Technical Bulletin.
PRS Beta Release Planned for Early Next Year PRS Beta will be released to the PRS Test system in early 2022, giving users an opportunity to explore the new PRS experience, performance of new technology, and to provide feedback to help improve future PRS Beta releases. A recorded demonstration to preview PRS Beta is now available.

December 2, 2021

Webinar on ClinicalTrials.gov Modernization and Beta Website Demonstration: Join us on December 10, 2021, from 1:00 to 1:45 p.m. ET for an update on the modernization effort and a demonstration of the beta ClinicalTrials.gov website. Please register via the ClinicalTrials.gov webinar registration page. A recording of the webinar and the presentation slides will be made available for those who cannot attend the live event.

October 26, 2021

Modernization Webinar Materials Available: A recording of the October 7, 2021 webinar and slides describing the anticipated launch of beta ClinicalTrials.gov have been added to the ClinicalTrials.gov Modernization page.

October 08, 2021

Train-the-Trainer Materials Available: The materials from the August 2021 Results Database Train-the-Trainer virtual workshop are now on the Training Materials page. The topics covered in the workshop included an Overview of the Clinical Trial Disclosure Landscape, a PRS System Overview, NIH Requirements for Clinical Trials Registration and Reporting, PRS Results Module Introductions, and Example Studies for Results Data Entry.
Glossary Term Updates: Definition for Results First Posted with QC Comments is now available in the Glossary and the terms, Results First Posted and First Posted, have been updated for clarity. In addition, the Results First Posted with QC Comments date is added to the ClinicalTrials.gov Key Record Dates.

September 16, 2021

Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated launch of beta ClinicalTrials.gov. A recording of the webinar and slides will be made available for those who cannot attend live.

May 17, 2021

Train-the-Trainer Workshop Application Period is Closed: The application period for the Results Database Train-the-Trainer Workshop for August 2021 is closed. See the Training Materials page for more information on the workshop.

May 11, 2021

Downloading Content for Analysis: The ClinicalTrials.gov Beta API introduced in July 2019 is now the operational API. The Downloading Content for Analysis page has been updated to reflect this change, including links to the current XML schema and crosswalk linking data elements to corresponding API fields. Beginning on January 1, 2022, the previous API will no longer be supported.
An Additional Question Addressed in the Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19): An additional question (#6) and information from the NIH's Director's November 2020 Statement calling on researchers to swiftly share COVID-19 results has been added to the Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19) (PDF). Document is available on the Support Materials page.
Train the Trainer: The next Train-the-Trainer Workshop is scheduled for August 2021 and will be offered in an all-virtual format. Attendees must attend all five, two-hour live sessions on Tuesdays: August 3, August 10, August 17, August 24, and August 31. The application link is now available.

March 09, 2021

PRS Guided Tutorials: The PRS Guided Tutorials have new and updated content and features in response to feedback obtained through focus groups and survey responses over the past year. Updates include improved images and zoom functionality, additional study examples from materials developed for the behavioral sciences community, and revisions to the Introduction and tutorial content for added clarity and guidance. Also, two new sections have been added: Quick Overview Guides are designed to help users get the most from the tutorials, and the PDF Library has all of the tutorial content in a single place, readily available for download. Please note that audio narration has been removed.
Modernization Webinar Materials Available: A recording of the February 18 webinar and slides describing the progress of the modernization effort have been added to the ClinicalTrials.gov Modernization page, including information on how to volunteer to provide user feedback.

January 25, 2021

Webinar on ClinicalTrials.gov Modernization: Join us on February 18, 2021, from 3 to 4 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts, the RFI, and ways to share your feedback. A recording of the webinar and slides will be made available for those who cannot attend live.
New and Updated FAQs to Clarify the Deadline for Submitting Certifications for Delayed Submission of Results Information: The Frequently Asked Questions (FAQs) page has new and updated content under the Results Information and Submission Deadlines section:
- New FAQ: What is the deadline for submitting a certification for delayed submission of results information?
- Updated related FAQs to clarify that responsible parties may only submit certifications for delayed submission of results information prior to the date of (i.e., the day before) the standard submission deadline for results information. The standard submission deadline for results information is no later than 1 year after the ACT's primary completion date.

2020

December 22, 2020

Race and Ethnicity Reporting for Clinical Trials in ClinicalTrials.gov and Publications: A brief communication, "Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications," was recently published in Contemporary Clinical Trials and is now available in Selected Publications.
NIH-Funded Basic Experimental Studies with Humans Registration and Results Reporting Webinar Recording Available: The slides and recording are available on the Support Materials page from the December 7, 2020 webinar summarizing findings from NLM's analysis of challenges in registering and reporting results information for Basic Experimental Studies with Humans (BESH) on ClinicalTrials.gov and issues to consider.

December 08, 2020

New Advanced Search Feature: The ability to search for study records with Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801) Violations is available in Advanced Search and an accompanying definition for 'FDAAA 801 Violations' is now available in the Glossary. NLM adds FDAAA 801 Violations to study records after this information is provided by the FDA.
New Study Design Examples: The Training Materials page has two new study design examples for results data entry, Micro-Randomized and Sequential, Multiple Assignment, Randomized Trial (SMART).

November 10, 2020

NIH Director's Statement: NIH calls on clinical researchers to swiftly share COVID-19 results by registering their clinical trials and submitting COVID-19 and SARS-CoV-2 summary research results as quickly as possible and ahead of regulatory and policy deadline requirements to ClinicalTrials.gov.

October 1, 2020

Frequently Asked Questions: The Frequently Asked Questions (FAQ) page was updated on September 24, 2020 with a new FAQ:
- My clinical trial evaluating a benign behavioral intervention is exempt human subjects research per Exemption 3 outlined in 45 CFR 46. How do I indicate this exemption when registering the clinical trial at ClinicalTrials.gov?
Regarding Submission of Results Information: The History, Policies, and Laws and Frequently Asked Questions pages have been edited to provide further clarity to responsible parties on the Federal Court Decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020).

September 17, 2020

New Study Design Examples: Two new study design examples for results data entry, Cluster Randomized and Fractional Factorial and have been added to the Training Materials page.

August 18, 2020

FDA Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020): Information and links related to the FDA Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020) have been updated on the FDAAA 801 and the Final Rule, Support Materials, and Final Rule (42 CFR Part 11) Information pages. Additionally, an FAQ, To which trials do the potential legal consequences described in 42 CFR 11.66 apply?, has been updated.

July 28, 2020

Regarding Submission of Results Information for ACTs Subject to the Registration Requirements and Completed Before January 18, 2017, Following the Federal Court Decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020): The History, Policies and Laws page and Frequently Asked Questions have been updated to provide clarity to responsible parties:

June 16, 2020

Results Submitted and Results Returned Dates Available in Archive Site: The dates for Results first submitted and Results returned after quality control review were added to the study record archive site.

May 28, 2020

Modernization Public Meeting Materials Available: Recordings from the April 30, 2020, virtual public meeting, including transcript and slides, have been added to the ClinicalTrials.gov Modernization webpage.

April 28, 2020

Two Additional Questions Addressed in the Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19): Additional questions (4 and 5) have been addressed in the Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19) (PDF). Document is available on the Support Materials page.
ClinicalTrials.gov Modernization Public Meeting: The agenda (PDF) for the virtual public meeting scheduled for April 30, 2020 is available. For more details and to register, visit the public meeting website.
Responses to the ClinicalTrials.gov Modernization RFI: The Public Comments Received in Response to Request for Information (RFI): ClinicalTrials.gov Modernization (PDF) and the ClinicalTrials.gov Summary of Responses to the RFI (PDF) are now available on the ClinicalTrials.gov Modernization page.

April 2, 2020

Answers to Questions from Responsible Parties on Submitting Information to ClinicalTrials.gov Related to Coronavirus (COVID-19) Available: Questions about submitting information to the ClinicalTrials.gov Protocol Registration and Results System (PRS) have been addressed in Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19) (PDF). COVID-19 is an emerging, rapidly evolving situation. These responses will be updated as needed. Document is available on the Support Materials page.
Train-the-Trainer Workshop Postponed: The Results Database Train-the-Trainer Workshop scheduled for May 18-19, 2020 is canceled and will be rescheduled at a later date. Updates will be provided when they are available.
PRS Guided Tutorials Registration Content Available: The PRS Guided Tutorials now include registration content providing step-by-step instructions for submitting registration and results information in the ClinicalTrials.gov Protocol Registration and Results System (PRS).
ClinicalTrials.gov Modernization Public Meeting: The public meeting scheduled for April 30, 2020 will be entirely virtual. For more details and to register, visit the public meeting website.

March 16, 2020

Train-the-Trainer Workshop Application Period is Closed: The application period for the Results Database Train-the-Trainer Workshop on May 18-19, 2020 is closed. See the Training Materials page for more information on the workshop.

March 2, 2020

Registration Open for Modernization of ClinicalTrials.gov Public Meeting: Register to attend the meeting taking place April 30th, 2020 on the NIH campus in Bethesda, MD. This public meeting is part of NLM's overall effort to obtain input on modernizing ClinicalTrials.gov to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency.

February 21, 2020

Registration Open for May Train-the-Trainer Workshop: See the Training Materials page for information on how to register for the May 18-19, 2020 Results Database Train-the-Trainer Workshop. The workshop will be held in on the NIH campus in Bethesda, MD.

January 29, 2020

Modernization Webinar Materials Available: A recording of the January 22 webinar and slides have been added to the ClinicalTrials.gov Modernization page.
New Advanced Search Fields: Two new fields have been added to the Advanced Search page: Results First Posted and Results Submitted. Results First Posted can be used to find studies based on the date summary results were first available on ClinicalTrials.gov. The Results Submitted field can be used to find study records based on whether the study sponsor or investigator has submitted summary results information and if submissions with QC comments are available.
National Library of Medicine Technical Bulletin Article on Updated Posting Procedures: This article highlights key features of the recent updates to ClinicalTrials.gov procedures for posting results information submitted for applicable clinical trials.

January 15, 2020

Information Page for ClinicalTrials.gov Modernization Now Available: The ClinicalTrials.gov Modernization page includes links to resources about the initiative. It will continue to be updated as more information becomes available.
New Study Design Example: A new example study for results data entry, Units Other Than Participants, has been added to the Training Materials page.

January 7, 2020

ClinicalTrials.gov Modernization RFI: The National Library of Medicine (NLM) has issued a Request for Information (RFI) seeking public input to guide us in planning infrastructure enhancements aimed at ClinicalTrials.gov users and submitters as part of a multi-year modernization initiative. For more information on opportunities to engage with us to enrich and modernize ClinicalTrials.gov, see this guest post on the NLM Musings from the Mezzanine blog.
Webinar on ClinicalTrials.gov Modernization and How to Provide Input: Join us for a webinar on January 22, 3:30-4 pm ET, about ClinicalTrials.gov Modernization. Register to learn more about the modernization efforts, the RFI, and ways to share your feedback. A recording of the webinar and slides will be made available for those who cannot attend live.

2019

December 17, 2019

Implementation Update on Changes to Posting Procedures for Applicable Clinical Trials: The Training Materials and Final Rule (42 CFR Part 11) Information pages have been updated to specify the implementation date for the change in procedures to meet the requirement to post results information for applicable clinical trials within 30 days of submission. As of January 1, 2020, initial results submissions for applicable clinical trials that do not meet quality control criteria will be publicly posted on ClinicalTrials.gov with brief standardized major comments. Also available is the Major Comments List containing the complete list of brief standardized major comments that may be provided to the responsible party by National Library of Medicine staff during the quality control review conducted to identify apparent errors, deficiencies, or inconsistencies in a submitted study record.
New England Journal of Medicine Article on Results Information Submission: This article describes the current requirements, challenges, and opportunities for results information submission, 10 years after the ClinicalTrials.gov results database was launched. This and other publications by ClinicalTrials.gov staff are available on the Selected Publications page.

November 5, 2019

Answers to Questions from Updated Quality Control and Posting Procedures Webinar Available: Questions regarding the October 15, 2019 Webinar have been addressed in Top Questions About the Updated Quality Control and Posting Procedures for ClinicalTrials.gov (PDF). Materials from the webinar are available on the Training Materials page.

October 22, 2019

Webinar Materials Available: Materials from the October 15, 2019 Updated Quality Control and Posting Procedures Webinar, have been added to the Training Materials page. A recording of the presentation and slides are available.

October 8, 2019

New FAQs on 42 CFR Part 11 Requirements: The Frequently Asked Questions (FAQs) page has been updated with four new FAQs:

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.

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: 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

New ClinicalTrials.gov API Now in Beta: A new ClinicalTrials.gov Application Programming Interface (API) is available for beta testing and feedback. After further development, it is intended to replace the current API.
Resources for NIH-Funded Clinical Trials Added: The Support Materials page has been updated with information on the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research and the Guidance on Posting Informed Consent Forms for NIH-Funded Clinical Trials.
Results Database Train-the-Trainer Workshop Dates Announced: The Training Materials page has been updated with more information about upcoming Results Database Train-the-Trainer Workshops. More information, including how academic organizations can register to attend, will be added to the Training Materials page closer to the workshop dates.

April 11, 2019

AHRQ RoPR Discontinued: The Agency for Healthcare Research and Quality (AHRQ) Registry of Patient Registries (RoPR) will be discontinued in April 2019. ClinicalTrials.gov is no longer including a link to RoPR on study records that were available in the registry.
ICMJE Updates: The Support Materials and study record pages have been updated with more information related to the International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. The WHO (ICMJE) Cross Reference has been updated to include information about the IPD Sharing Statement requirement. Additional ICMJE notations have been added to the tabular view for a study record to indicate interventional study data elements required by the ICMJE.
Information Now Available on Revised Common Rule Informed Consent Form Posting: Information from the Office for Human Research Protections (OHRP) about the Revised Common Rule (45 CFR Part 46) clinical trial consent form posting requirement has been added to the Support Materials page.

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

Additional Resources Added to the Other Sites About Clinical Studies page: More resources relevant to research participation have been added to this page. These resources include links to videos from the Office for Human Research Protections (OHRP) as well as informational webpages from National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA).
The Support Materials page has been updated with new information on the Request for Information (RFI): Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants issued by NIH in August 2018 and closed for comments in November 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

New FAQ Posted: The Frequently Asked Questions (FAQs) page has been updated with one new FAQ:
For an applicable clinical trial (ACT) for which results information must be submitted under 42 CFR 11.42, if a certification of delay for an unapproved product ("certify initial approval") has been submitted under 42 CFR 11.44(c) and the sponsor later decides to discontinue development of the product, when are results due?
Information on the revised Common Rule (45 CFR Part 46) clinical trial consent form posting requirement has been added to the Support Materials and History, Policies, and Laws pages.
The Support Materials page has been updated with information on the Request for Information (RFI): Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants issued by the NIH in August 2018. Included are links to resources to help inform comments on this RFI.
Informational links to the FDA Draft Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (PDF) (September 2018) have been added to the FDAAA 801 and the Final Rule, Support Materials, and Final Rule (42 CFR Part 11) Information pages. Additionally, the FAQ "To which trials do the potential legal consequences described in 42 CFR 11.66 apply?" has been updated with a link to the draft guidance.

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

Voluntary Submission Flowchart and Triggered Trials Checklist has been modified with minor formatting changes to improve readability.

June 27, 2018

New and Updated FAQs and Related Materials on 42 CFR Part 11 Requirements:
- Four new Frequently Asked Questions (FAQs) addressing voluntary submissions were added under a new Voluntary Submissions section:
- New Voluntary Submission Flowchart and Triggered Trials Checklist was added to help responsible parties identify voluntary submissions and triggered trials under section 402(j)(4)(A) of the PHS Act and 42 CFR 11.60.
- Updated FAQ: The FAQ "Is a clinical trial using a radiation-emitting product a trial that 'Studies a U.S. FDA-regulated Device Product'?" has been updated to include additional background and clarifying information.
- Updated Applicable Clinical Trial Checklist: The Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial has been updated to integrate information from recent FAQs.
Updated ClinicalTrials.gov Quality Control Review Criteria Available: The Support Materials page has been updated to include updated Quality Control (QC) Review Criteria documents. These documents reflect the current QC review process, including review of data elements added by the Final Rule, and are intended to help responsible parties prepare study records with protocol registration and results information:
- ClinicalTrials.gov Protocol Registration Quality Control Review Criteria
- ClinicalTrials.gov Results Quality Control Review Criteria
Minor Updates to Data Element Definitions: The Protocol Registration Data Element Definitions and Results Data Element Definitions have been updated with minor editorial changes. The Data Element Definitions can be accessed from the Data Element Definitions, Templates, and Checklists section of the Support Materials page.

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

New FAQs on 42 CFR Part 11 Requirements: Three new Frequently Asked Questions (FAQs) were added to the Applicable Clinical Trial section and the Registration Information and Submission Deadlines section:
Revised FDAAA 801 and the Final Rule Page: The FDAAA 801 and the Final Rule page was updated to include an overview of the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) and references to key regulatory provisions and related discussion in the preamble of the Final Rule.

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.

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