Clinical Research Regulatory Start-Up & Management

The SOM CTU is committed to providing investigators with expert regulatory support utilizing regulatory coordinators who are ready to assist with study activation and maintenance of regulatory records.

Examples of regulatory services that our team can provide:

• Submission to the IRB of record, including UVA IRB-HSR or central IRB and other internal committees
• Share regulatory documentation with sponsors as required through study activation and UVA Site Initiation Visit (SIV)
• Creation and submission of all IRB amendments after initial approval and maintenance of regulatory master file until study closure
• Archival of study materials after closure

The Food and Drug Administration (FDA) defines an IND, or investigational new drug application, as a request for authorization from the FDA to administer an investigational drug or biological product to humans. Similarly, an IDE, or investigational device exemption, allows an investigational device to be used in a clinical study to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to the FDA.

Many researchers make the mistake of not filing an IND or IDE when regulations dictate they must. When a researcher becomes a sponsor-investigator, it is imperative that they become aware of the specific obligations in their roles as both the investigator and sponsor of the study. The goal of the Clinical Research Start-Up & Management team is to ensure compliance with all applicable regulations in maintaining and conducting research under INDs/IDEs.

In addition to the initial IND/IDE application our team can also assist in completing required annual reports.

Our team of research professionals can assist Principal Investigators and study teams in the drafting and editing of clinical trial protocols and related documents (e.g., informed consent forms).

Clinical Research Regulatory Start-Up & Management team services are available as fee for service support. These services can be used by any UVA investigator who needs regulatory support.

• Regulatory support is billed hourly.
• All project specific time is tracked in Oncore and the PI will be invoiced monthly.
• Regulatory Program Manager can give an estimate of support hours for the budget after review of initial study documents and protocol.

Inquiries regarding the Clinical Research Regulatory Start-Up & Management team services should be directed to somcturegsupport@uvahealth.org