As of April, new federal requirements and regulations for registering clinical trials on ClinicalTrials.Gov have gone into effect.
For more information
Trials that are considered an Applicable Clinical Trial (ACP) or are federally funded are required to be registered with ClinicalTrials.Gov.
ACPs are:
- interventional drug or device trials that have one or more sites in the United States;
- conducted under an investigational new drug application of investigational device exemption; or
- involve a drug or device that is manufactured in the United States and then is exported for research purposes.
A checklist to assist in determining whether a trial is an ACP is available on ClinicalTrials.Gov. Additionally, journals may require ClinicalTrials.Gov registration as a condition for publication. Investigators are advised to check with the applicable journals for their requirements for publication.
After initial registration on the website, there are important deadlines to meet. For ACTs, the required trial information must be completed and submitted no later than 21 days after enrollment of the first subject. Each registered trial must be updated annually as well as each time recruitment status changes. Clinical trial results must be submitted no later than one year after the primary completion date. Results submission extensions can be requested in specific circumstances, but please note pending publication is not considered a good reason for an extension.
For trials found to be in non-compliance, there have been new consequences put into effect. Failing to comply with deadlines can result in a $10,000 fine against the investigator and/or institution. If the same trial is found to still be in non-compliance 30 days after initial fine, the investigator or institution can be subject to a $10,000 fine per day of violation until trial is in compliance.
In addition to monetary fines, non-compliance can result in withholding of funds for federally funded studies. At UNMC, future studies may be suspended or approval may be withheld if investigators have studies on ClinicalTrials.Gov that are in non-compliance. The vice chancellor of research will be notified of investigators that have studies in non-compliance.
If you have any questions regarding ClinicalTrials.Gov, please contact Krista Bayley in the Office of Regulatory Affairs, 402-559-5845.