December 2019: What’s New on ClinicalTrials.gov PRS

ClinicalTrials.gov PRS posted following update on December 30, 2019:

Changes to Posting Procedures for Applicable Clinical Trials

Consistent with requirements under 42 CFR 11.52, NIH must post results information for applicable clinical trials (ACTs) on the public website within 30 days of submission, regardless of whether the quality control (QC) review process is complete. For more information, see the Final Rule (42 CFR Part 11) Information page.

As of midnight EST (05:00 UTC), January 1, 2020, initial results submissions for ACTs that do not meet QC criteria will be posted publicly on ClinicalTrials.gov along with the brief standardized major issues. For details on the new procedures see the ClinicalTrials.gov Webinar: Updated Quality Control and Posting Procedures.

Major Comments List

The complete list of ClinicalTrials.gov Major Comments (issues) that may be provided to the responsible party by National Library of Medicine staff during QC review is now available on the ClinicalTrials.gov public website. This list will be updated as major comments are added or retired from use.

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