The Clinical Trials Office (CTO) is pleased to offer new regulatory support services: study activation and on-going regulatory support.
We have established a new regulatory compliance team based in the Clinical Trials Office which will closely collaborate with our researchers, institutional review boards, and relevant regulatory bodies to ensure compliance and promote maximum participant protection. The regulatory compliance team will manage all regulatory aspects of study activation, including submission to local and central IRBs, submission to all required internal review groups, collection and/or completion of all required regulatory documents, and registration with Clinicaltrials.gov, followed by the ongoing maintenance of all protocol modifications and regulatory study documents.
This service is designed to alleviate study staff administrative duties, allowing the research team to focus on subject recruitment and data management. Regulatory coordination provided by the CTO is a fee-based service at $100/hour. All researchers are welcome to request regulatory support; for all cancer-related studies, the Cancer Center will continue to provide support.
For more information about the Regulatory Compliance Department for Clinical Research and our ongoing commitment to ethical and compliant research practices, please contact us at CTOregsupport@uvahealth.org
Filed Under: Research