Clinical Trials Office

Overview of Services

Study Coordination Services
The Clinical Trials Office provides an initial review and analysis of GRU industry-sponsored research studies.
Projects ready for institutional approval are entered into a campus wide tracking system.
Personal attention and intervention ensure an efficient approval process.

Centralized Services
The Clinical Trials Office provides:

• Single contact point for investigators, clinical research staff, and corporate sponsors.
• Clearing house for confidentiality Disclosure Agreements, Clinical Trial Agreement, Material Transfer Agreements, Data Use Agreements
• Clearinghouse for current and potential clinical research projects
• Initial review and analysis of proposed protocols and budgets
• Tracking of each clinical research project through the approval process
• Liaison services between investigators and other GRU offices that work with clinical research
• Access to the hospital Translational Research Unit (TRU) and Children’s Hospital of Georgia Research Unit (CRU).

Specialized Services
Investigators can select additional services for a fee:

• Budget preparation and Contract/Budget negotiation
• IRB Application and Informed Consent document assistance
• Patient screening and recruitment
• Study coordination
• Patient visit and procedure scheduling
• Licensed staff to conduct procedures and monitor patient health
• Financial management of study accounts
• Case Report Form completion
• Clinical trial regulatory material preparation and maintenance
• Space and equipment to conduct research
• Processing and storage of patient specimens

Dedicated Research Facilities

• Phlebotomy room
• Procedure rooms
• Approved BSL2 laboratory (-20 and -80 freezers, and temperature-controlled centrifuges)
• Patient and Family Education and resources
• Clinical Research Monitoring area
• Crash Cart and AED available
• Handicapped accessible building with all patient areas on the ground floor
• Free curbside parking

Quality Assurance
All studies conducted in accordance with the Code of Federal Regulations, Good Clinical Practices, the Health Insurance Portability and Accountability Act, and institutional policies
Standard Operating Procedures

Leadership

Carol Smith
Director
(706) 721-9680
csmith@augusta.edu

Location and hours of operation

Links and Resources

1. www.gru.edu/research/cts/
2. www.gru.edu/research/cts/cto/index.php
3. www.gru.edu/research/cts/cto/forms.php