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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