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. Its mission is to facilitate clinical research by providing quality services, solutions, innovative leadership, the promotion of collaboration, and continuous quality improvement.  Its 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.  SOME OF THE SERVICES INCLUDE:

  • 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 the hospital and an outpatient study clinic with a BSL2 approved lab), examination/treatment rooms, space for monitors and auditors and family/patient waiting areas

Dr. Diamond and associates

*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.
  • 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

Contact Us

Clinical Trials Office
Health Sciences Campus
AU Medical Center, RM 7309
1120 15th Street
Augusta, GA 30912
   706-721-6582  
   ctscto@augusta.edu