91Â鶹

Research Study Initiation Processes

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

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 91Â鶹 offices that work with clinical research

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