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- Informational links to the FDA Draft Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (PDF) (September 2018) have been added to the FDAAA 801 and the Final Rule, Support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 has been updated with a link to the draft guidance.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:
- What types of clinical trials are considered voluntary submissions subject to the regulation?
- What are the clinical trial information requirements for voluntary submissions under the regulation?
- What is a "triggered" trial under the regulation?
- When must clinical trial information for a "triggered trial" be submitted to meet the requirements for voluntary submissions under 42 CFR 11.60?
- 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.
- Four new Frequently Asked Questions (FAQs) addressing voluntary submissions were added under a new Voluntary Submissions section:
- 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:
- 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:
- Is a study coordinating center located in the United States considered to be a "Facility Location" within the United States for evaluating whether a study is an applicable clinical trial?
- At what point is a human subject considered to be "enrolled" in an applicable clinical trial?
- What is the Primary Completion Date and/or Study Completion Date when an outcome is measured or assessed after a study participant has been examined or received an intervention for that outcome?
- 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.
- 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).
March 22, 2018
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.
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.
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