Background
With the codification of 42 CFR Part 11 in 2017, applicable clinical trials (ACTs) must be registered on ClinicalTrials.gov. This website shares information about study design and results, allowing anyone with internet access, including prospective patients, to stay current on clinical research across fields and to determine unmet research needs. (Curious if your study is an ACT? Check out this handy checklist).
ClinicalTrials.gov promotes scientific integrity and reduces publication outcome reporting biases because the information is standardized and reviewed by the National Institute of Health (NIH) before it is published. Furthermore, if a study is seeking Centers for Medicare & Medicaid Services (CMS) coverage for its subjects, it needs to be registered on ClinicalTrials.gov. Therefore, the creation and maintenance of a study record on ClinicalTrials.gov is both a necessary and important step in any ACT. We have a lot of experience diligently managing these records on behalf of sponsors, and we wanted to share a few tips to help you ensure compliance with the ClinicalTrials.gov requirements for your studies.
Timely registration
ACTs must be registered no later than 21 days after the first human subject enrollment. We recommend you not wait until day 20 to initiate this process. Instead, we suggest that you write a draft study record and obtain internal team reviews during the study start-up and launch period, well in advance of any enrollments. You can then submit that draft record to ClinicalTrials.gov to receive an NCT number (the ClinicalTrials.gov study identifier) and begin the quality control review phase. This ensures you have time to incorporate any ClinicalTrials.gov feedback and post the record well before sites are activated for enrollment. When that first enrollment occurs, you simply need to update the record status to “recruiting” and add the actual study start date. Easy peasy! Now that this registration is completed, you can check off this initial ClinicalTrials.gov task and direct all your attention to achieving the second enrollment and beyond.
Record maintenance
The study record on ClinicalTrials.gov needs to be verified at least every 12 months to ensure the study information is up to date and accurate. However, certain data elements, like changes to the responsible party or individual site statuses, need to be updated within 30 days. Bright recommends using a recurring calendar reminder or tracker tool to alert the team that it’s time to request updates from the sponsor and modify those data elements as needed.
Disclosure of results
Within one year after the study completion date, the responsible party must update the ClinicalTrials.gov study record with endpoint data, the full protocol, and the statistical analysis plan, which will be reviewed by the NIH and then published publicly on the site.
For consistency and ease of data entry in the results section of ClinicalTrials.gov record, we recommend deriving your ClinicalTrials.gov record update from your final Clinical Study Report (CSR). The CSR should already have all data tables organized by baseline characteristics, outcome measures, and adverse events, which will allow for an easy transfer of data into the study record. Additionally, since ClinicalTrials.gov categorizes its adverse events with organ system classification, consider using MedDRA coding to ease classifying adverse events during results data entry.
Enforcement of compliance
While FDA and NIH encourage voluntary compliance with ClinicalTrials.gov requirements, it’s important to know that enforcement of ClinicalTrials.gov compliance is incorporated into FDA’s Bioresearch Monitoring (BIMO) program through inspections, compliance evaluations, and surveillance efforts. Any noncompliance with ClinicalTrials.gov requirements (e.g., failing to submit clinical trial information or submitting false or misleading information) can lead to pre-notice letters requesting corrections to violations, a notice of noncompliance, or a civil money penalty.
Conclusion
We hope these recommendations are helpful in ensuring your ClinicalTrials.gov records are created and maintained in compliance with the regulations. Not only is it required, but through diligent recordkeeping, anyone who views the study records on ClinicalTrials.gov can be assured the information presented is a proper reflection of the study.
