Tips for meeting the requirements

by | Nov 27, 2023 | ClinReg Strategy


With the codification of 42 CFR Part 11 in 2017, applicable clinical trials (ACTs) must be registered on 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). 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 Therefore, the creation and maintenance of a study record on 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 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 to receive an NCT number (the study identifier) and begin the quality control review phase. This ensures you have time to incorporate any 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 task and direct all your attention to achieving the second enrollment and beyond.

Record maintenance

The study record on 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 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 record, we recommend deriving your 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 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 requirements, it’s important to know that enforcement of compliance is incorporated into FDA’s Bioresearch Monitoring (BIMO) program through inspections, compliance evaluations, and surveillance efforts. Any noncompliance with 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.


We hope these recommendations are helpful in ensuring your 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 can be assured the information presented is a proper reflection of the study.

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