Research Roundtable: Top Questions About the Updated Quality Control and Posting Procedures for ClinicalTrials.gov
Published June 11, 2024
Following a recent series on ClinicalTrials.gov “FAQ” sections, the CTSI is exploring quality control and posting procedures.
To keep research teams informed of the latest updates to ClinicalTrials.gov, the University at Buffalo Clinical and Translational Science Institute (CTSI) is providing news about the ClinicalTrials.gov website and online database of clinical research studies and results information throughout the year. Following a recent series on “FAQ” sections (found here), the CTSI is exploring quality control (QC) and posting procedures.
Consistent with Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), the National Library of Medicine (NLM) publicly posts results information within 30 days of submission, regardless of whether the QC review process has been completed.
To help responsible parties understand these procedures, relevant questions and answers are provided below:
To which studies do these procedures apply?
These procedures apply only to studies that satisfy all of the following criteria:
- Is an Applicable Clinical Trial
- Has a study start date that is on or after January 18, 2017 (the effective date of the Final Rule)
- First submitted results information on or after January 1, 2020
For more information on identifying ACTs, see Section 8.1.2 of the PRS User’s Guide.
Which comments are publicly visible? Are advisory comments shown?
Only the brief, standard major comments that identify the relevant section are publicly posted, and a general note that the QC review process has not concluded is included. (See images of major comments, as they appear publicly, below.) Advisory comments are not publicly posted.
Do I have an opportunity to address a study record with major comments before it’s publicly posted?
No, the study record is posted with major comments after NLM’s QC review. The responsible party is notified by email directly from ClinicalTrials.gov when QC review comments, and any further explanations of the issues, are available.
If I submit results before the submission deadline, do these procedures still apply?
Yes, the procedures apply as long as the study record meets all the criteria listed in the first question above.
NLM has an obligation to publicly post submitted results information within 30 days of submission.
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