Standard Operating Procedures

The Research Institute/Clinical Research Administration Division Standard Operating Procedures outline and emphasize the correct conduct for conducting a clinical trial. The SOP templates are based on Good Clinical Practice Guidelines and the Code of Federal Regulations.

In the text of the SOP, the initials for Institutional Review Board (IRB) are synonymous to the KUMC Human Subjects Committee (HSC).

• Table of Contents (Coming Soon)
• Contact Information for Scheduling Clinical Trial Tours (PDF)
  
  Pre-Study Activity
• TBD     : Confidentiality Agreement with Sponsor (PDF)
• 200.7.0: Assurance of Financial Disclosure (FDF) by Clinical Investigators (PDF)
  
  Sponsor Visits
• 100.1.0: Site Evaluation Visits  (PDF)
• 100.2.0: Handling Site Initiation Visits (PDF)
• 100.3.0: Handling Monitoring Visits (PDF)
• 100.4.0: Handling Closeout (Study Termination) Visits (PDF)
  
  IRB
• 500.1.0: Obtaining IRB review and maintaining IRB approval (PDF)
• 500.2.0: Handling IRB Correspondence (PDF)
• 500.3.0: Managing Protocol Amendments (PDF)
• 500.4.0: Advertising for study subject recruitment (PDF)
  
  Study Management
• 200.1.0: Documenting Delegation of Authority (PDF)
• 200.5.0: Handling General Correspondence (PDF)
• 200.8.0: Regulatory File Management (PDF)