Updated ClinicalTrials.gov Quality Control Review Criteria
On June 27, 2018, ClinicalTrials.gov posted updated support documents reflecting the current quality control (QC) review process, including review of data elements added by the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) for protocol registration and results information.
ClinicalTrials.gov QC Review Process
The ClinicalTrials.gov QC review process conducted by the Protocol Registration and Results System (PRS) Team is unique. As part of the QC review process, the PRS reviewer may provide comments noting either 'Major' issues or 'Advisory' issues. Advisory issues are only suggestions; they do not require updating the posting. A posting with Advisory issues will move on to being posted publicly either way. However, Major issues must be corrected or addressed. The QC review process only ends when all Major Issues have been resolved.
The responsible party is responsible for ensuring that the protocol registry/results disclosure posting follows all applicable laws and regulations and that the study record is consistent with the updated protocol registration QC review criteria and the updated results QC review criteria.
There's criteria around everything from what information should be included on the cover page of a redacted protocol/statistical analysis plan to the use of abbreviations and acceptable Outcome Measure Titles in the protocol registry/results disclosure postings. Understanding all of the criteria and addressing PRS review comments can be a time-consuming administrative burden. In our work with protocol registry/results disclosure postings, we have found that some Major issues have been reported in error. They can be easily addressed with the experience and expertise that comes with multiple postings.
With Synchrogenix's transparency & disclosure solutions, we can handle the entire postings process for you, from redaction of your documents to making sure all review comments are addressed. Visit our website to learn more about our transparency and disclosure services, or contact us today.