Release of New Interventional Study Protocol Registration Template and Updated Results Data Preparation Checklists (January 25, 2018)
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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