SOPs and Policies

Administrative

• SOP 100: SOP Development, Approval, Training, and Maintenance
• SOP 101: Interim Monitoring Visits and Closeout Visits
• SOP 102: Trial Master Files
• SOP 103: Archiving
• SOP 104: Accrual Closure Policy
• SOP 105: FDA Inspections
• SOP 106: CTA and Budget Negotiation
• SOP 107: Billing Compliance
• SOP 108: Clinical Trials Invoicing
• SOP 109: Financial Conflicts of Interest

Regulatory

• SOP 200: Study Start-Up
• SOP 201: Regulatory Start-up and Initial IRB Submission 
• SOP 202: IRB Approval Distribution
• SOP 203: Investigator Registration and Regulatory Compliance 
• SOP 204: Ongoing Regulatory Submissions 

Patient Coordination and Management

• SOP 300: Subject Screening 
• SOP 301: Informed Consent 
• SOP 302: Patient Registration and Ongoing Subject Management 
• SOP 303: Electronic Medical records (EMR) 
• SOP 304: Data Management 
• SOP 305: AE, SAE, and UAP Reporting
• SOP 306: Specimen Collection and Handling 

Pharmacy and Device Management

• SOP 400: Investigational Device Management
• SOP: Pharmacy: Chemotherapy Drug Preparation Procedures
• SOP: Pharmacy: Disposal Recommendations & Spill Management
• SOP: Pharmacy: Investigational Medications
• SOP: Pharmacy: Transport of Medications
• SOP: Pharmacy: Waste Management