What's New


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 Researchers are increasingly using information from to assess clinical research reporting practices or to characterize the clinical research enterprise. A recently published research methods and reporting article by 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 staff are available on the Selected Publications page.

May 11, 2018

  • Archive Site Enhancements: The 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