December 2019: What’s New on ClinicalTrials.gov

What’s New section of the ClinicalTrials.gov was updated with the following post on 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.

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