CTRU Standard Operating Procedures

100 Administrative

101 Writing, Training, and Maintenance of SOPs
102 Delegation of Responsibilities
103 Principal Investigator Responsibilities for Sponsored Trials
104 Sponsor Interactions
105 CTRU Billing Procedure
106 Inclement Weather and Emergency Closure Procedures

200 Trial Management

201 Essential Document Management and Retention
202 Investigator Agreements with Sponsors/CROs
203 Protocol Handling, Review of Feasibility, and Approval
204 Clinical Study Operations
205 Clinical Study Supplies
206 Storage of Frozen Research Samples
207 CTRU Biorepository

300 Regulatory

301 IRB Approval and Operations for Clinical Studies
302 Informed Consent Process
303 FDA Inspection and Prepartion

900 Assessment and Equipment Guidance

901 Venipuncture
902 Twenty Four Hour Urine Collection
903 Peripheral IV Catheter Placement and Management
904 Muscle Biopsy
905 Adult and Pediatric Oral Glucose Tolerance Test
906 Pharmaceutical Compounding
907 DEXA
908 MRI
909 ECG
910 Use of ActiGraph Activity Monitor
911 Cholestech LDX
912 Equipment Loan