Standard Operating Procedures

The WVCTSI Clinical Trials Center of Excellence Standard Operating Procedures will provide harmonized guidance to help define standard practices and ensure execution of human subject research is in accordance with institutional, state and federal regulations.

Standard Operating Procedure Table of Contents

• Mission, Goals and Governance
• External Audit Management
  • Attachment - Audit Checklist
  • Attachment - Employee Guidelines during the Audit Process
• Quality Management System and Standards
  • Attachment- Corrective and Preventive Action (CAPA) Form
  • Attachment- Corrective and Preventive Action (CAPA) Letter
• Registration of Clinical Trials
• Clinical Research Personnel Responsibilities and Training Program
  • Attachment - Site Training Record
• Utilization of OnCore for Clinical Research
• OnCore: Access
  • Attachment - OnCore Access Request
  • Attachment - OnCore User Matrix
• ClincialTrials.gov Disclosure
  • Attachment - Timeline of Requirements for ClinicalTrials.gov Disclosure
• Safety Reporting: Adverse Events, Unanticipated Adverse Device Effect, Protocol Deviations and UPIRTSO
• Informed Consent Process: Development and Implementation
• External Safety Reports
• Medicare Coverage Analysis
• Data Management: Security, Confidentiality, Sharing, Transmission, and Archiving
• Investigational Product Management
• Biospecimen Management
  • Attachment- Biospecimen Chain of Custody Tracking Form
• Sponsor/CRO Communication
• Institutional Review Board (IRB) Communication
• Clinical Trials Risk Assessment and Appeals Process
  • Attachment - Risk Assessment
• Electronic Signatures
• External Monitoring/Access
• Advarra eReg System Administration
• eReg Training and Access
  • Attachment - eReg Access Request 
• Clinical Research Participant Recruitment
  • Attachment - EPIC MyChart message template