Clinical Trials Office

The Clinical Trials Office (CTO) serves as the initial point of contact and centralized coordinating office for all clinical research conducted within the Augusta University Health System.

Our mission is to facilitate clinical research by providing quality services, solutions, innovative leadership, the promotion of collaboration, and continuous quality improvement. Our operation is based upon a comprehensive "One Stop Shop" concept for investigators and sponsors. The Clinical Trials Office provides oversight and management of clinical studies.

Current Clinical Trials

Dr. Diamond and associates

Contact Us

Clinical Trials Office

706-721-9680

ctscto@augusta.edu

AU Medical Center, RM 7309

1120 15th Street
Augusta, GA 30912

Our Services

Research Study Initiation Processes

Coordination of CDA, DUA, MTA, CTA, Feasibility and Site Questionnaires, etc.

Compliance Approval Preparation

IRB, Biosafety, Chemical Safety, Radiation Safety, etc.

Conduct of Clinical Trials

Recruitment, consenting, study conduct, study procedures (as appropriate), CRF completion, response to sponsor queries, and storage/distribution of specimens

Financial Management of Studies

Dedicated Research Facilities

Children's Research Unit (CRU) (located in Augusta University Medical Center and on Pope Avenue; an outpatient study clinic with a BSL2 approved lab), examination/treatment rooms, space for monitors and auditors and family/patient waiting areas

Study Coordination Services

Provides an initial review and analysis of industry-sponsored research studies.
Projects ready for institutional approval are entered into a campus wide tracking system.

Centralized Services

Single contact point for investigators, clinical research staff, and corporate sponsors.
Initial review of 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 Augusta University offices that work with clinical research
Access to the Children’s Hospital of Georgia Research Unit (CRU).

Specialized Services

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

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

Outpatient Research Facility

Clinical Trials Office has a dedicated outpatient facility for research study visits located at 1521 Pope Avenue on the Health Sciences Campus. This facility offers:

Phlebotomy room
Procedure rooms
Approved BSL2 laboratory (-20 freezer, and temperature-controlled centrifuges)
Patient and Family Education and resources
Clinical Research Monitoring area
Accessible building with all patient areas on the ground floor and free curbside parking
Ultra-sonography services for OB/GYN research patients/participants