CTU Service Spotlight – Clinical Research Regulatory Start-Up & Management

The UVA School of Medicine Clinical Trials Unit is a multi-tier resource for the entire UVA research community that is optimized to reinforce the “enabling discoveries for better health” goal of UVA Health’s strategic plan. In each edition of CTU Currents we will explore one of the various services offered by the CTU and in this edition we take a look at the Clinical Research Regulatory Start-Up & Management team.

Starting a clinical trial at UVA can be overwhelming, especially for new investigators navigating complex systems like IRB Protocol Builder, CRConnect, OnCore, and Florence eBinders. These powerful platforms streamline regulatory, and operational processes—but understanding how to use them effectively takes experience. That’s where the Regulatory team comes in. By partnering with the Regulatory team, new investigators gain expert support to accelerate study startup, ensure regulatory compliance, manage documentation, and access trained coordinators. With guidance from the Regulatory team, investigators can focus on their research while the Regulatory team helps lay a strong operational foundation for success.

“In the context of clinical research, the Clinical Research Regulatory Start-Up & Management team can play an integral part at every stage of project design, development and implementation”, says Amy Warren, MS, the manager of the team. “In addition to assisting with protocol development, our team of experienced regulatory coordinators are able to submit applications to the IRB of record, including the UVA IRB-HSR or a central IRB anywhere in the country. We can also manage modifications to the study and maintain regulatory documentation until study closure”, says Warren. By assuming these responsibilities, the Clinical Research Regulatory Start-Up & Management team allows the study team to better focus on patient care and scientific vigor in the conduct of their clinical research.

Examples of services provided by the Clinical Research Regulatory Start-Up & Management team include:

Protocol Development Service

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).

Regulatory Documentation Management Service

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

Investigational New Drug (IND) and Investigational Device Exemption (IDE) Service

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.

Unfortunately, some 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.

Payment and Fees

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.

Contact Us

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