The UNMC Office of the Vice Chancellor for Research and the Office of Regulatory Affairs are updating and expanding support for UNMC’s investigator-initiated studies registered on ClinicalTrials.gov.
To assist UNMC investigators in meeting the complex registration and reporting requirements in ClinicalTrials.gov, the two offices are rolling out an enhanced record monitoring and communication plans that will take effect on July 1.
Key enhancements include:
- Investigators and institutional leadership now will be kept apprised of records with update or reporting problems.
- For any studies experiencing issues with their ClinicalTrials.gov listing, UNMC’s ORA will provide a timeline for correction and assistance as needed.
- A CITI training course is available to UNMC and University of Nebraska at Omaha learners, which provides video instructions for registering, uploading documents and submitting results in ClinicalTrials.gov
- IRB protocols linked to ClinicalTrials.gov records are easily identified via color-coded icons in RSS. Red icons indicate records with problems, and green icons indicate records that currently are compliant.
Over the next few months, additional support and resources will be provided through UNMC’s ORA, including expanded ClinicalTrials.gov information on the UNMC IRB website, a new decision-making tool for determining registration requirements and timing and more robust processes for record management and closure.
The goal is to bring studies registered on ClinicalTrials.gov through UNMC into full compliance with federal regulations, while reducing the complexity and burden of this process on investigators.
The National Institutes of Health and U.S. Food and Drug Administration have increased their enforcement efforts against reports of registration and reporting failures. Penalties can include substantial monetary fines and the suspension of funding for an investigator or the institution.
However, by collaborating with UNMC’s ORA and following the updated process, UNMC and its investigators can achieve full compliance and avoid these consequences.
ClinicalTrials.gov, launched in 2000, serves as a publicly accessible registry for clinical trials. The database provides the public with clinical trial information, while offering researchers access to valuable study data, promoting transparency and informed decision-making in clinical research.
Please email the Office of Regulatory Affairs for more information.