ClinicalTrials.gov's PRS Review staff conduct a quality control review every time a record is registered or updated and released for publication. If the record does not meet their quality control criteria, they may issue one of two types of QC "comments":
"Advisory"comments appear in yellow. These are suggestions for improvements to the record, such as spelling checks, clarifications, or formatting changes. They don't prevent the record from being published, and you can't see them on the public website. Address them as appropriate.
"Major Issue"comments appear in red. These are inconsistencies and problems identified in the record that must be resolved. They include issues such as incomplete or inappropriately described outcome measures, discrepancies between data in different parts of the record. For example, an outcome measure with a title of "Number of participants with a change", but with a unit of measure entered as "Percent", rather than "Participants" would be returned with a comment:"Major issue: the unit of measure appears inconsistent".
In most cases, a Major Issue will prevent the record from being made public. However, for results submissions for Applicable Clinical Trials, the results will be posted flagged with Major Issues on the public facing website, and the public record will identify the parts of the record with unresolved QC issues until they are fixed.
