69 - Proactive Monitoring: ClinicalTrials.gov Registration and Results Reporting

Background:  There are laws, regulations, and policies that require some sponsors and investigators to register their clinical research studies and report results on ClinicalTrials.gov. The HRPP QA/QI Unit at this University created a monitoring program to mitigate non-compliance in this area and assist investigators in meeting their regulatory obligations.

Program

Description:  This university is a large institution, including an academic medical center, with a high volume of research. The QA/QI Unit maintains oversight of ClinicalTrials.gov records in 15 schools and colleges outside of the medical school. The QA/QI unit proactively monitors NIH defined clinical trials and Applicable Clinical Trials per FDAAA to ensure studies are registered and results are reported on ClinicalTrials.gov.

Compliance is monitored quarterly through review of information obtained from the IRB application system and the ClinicalTrials.gov Protocol and Registration System (PRS) database. Principal Investigators of studies identified as NIH defined clinical trials and Applicable Clinical Trials are notified via email of their registration and reporting requirements and are provided with guidance to register and/or report results for their trial. Studies are tracked internally until the study is registered and/or results are posted.

Program

Assessment:  The implementation of this monitoring program has been successful in educating investigators on ClinicalTrials.gov registration and reporting requirements and the potential penalties related to noncompliance. Monitoring has also increased awareness among investigators of the time frames associated with registering and reporting results. Specifically, that studies register within 21 days of enrollment of the first participant and results are posted no later than one year after the primary completion date for NIH defined clinical trials and Applicable Clinical Trials.

Additionally, monitoring efforts revealed investigators and study teams required additional assistance with how to register and report results on ClinicalTrials.gov. The QA/QI unit created guidance and a self-assessment tool to assist investigators with registering and reporting results.

Success in this area is measured by whether studies register and report results within the required time frames and the overall number of non-compliant records. Monitoring efforts are shared with HRPP leadership through an annual report.

Limitations: Monitoring compliance in this area is largely dependent upon the information in the IRB application and the ClinicalTrials.gov record, which is not always current, including funding information and study status. For example, if an investigator does not appropriately identify NIH funding associated with a clinical trial in the IRB application, the QA/QI unit is unable to proactively ensure the study registers on ClinicalTrials.gov.

Discussion:  ClinicalTrials.gov noncompliance can result in civil monetary penalties or withholding of remaining or future grant funds for the Principal Investigator and reputational harm to the institution. Implementing a proactive monitoring program can help prevent noncompliance. The QA/QI unit will continue monitoring efforts in this area.