Clinical Research Operations

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All Policies

• 100 Quality Management System Policy
• 101 Good Documentation Practices Policy
• 102 Audit Policy
• 103 Training Policy
• 104 Corrective and Preventive Action Policy
• 105 Quality System Requirements for Vendors Manufacturing Investigational Product Policy
• 201 Qualified Medical Expertise Policy
• 202 Protocol Development Policy
• 203 Clinical Trial Records Policy
• 204 Investigator's Responsibility Policy
• 205 Clinical Site Monitoring Policy
• 206 Clinical Site Activation Policy
• 207 Continuity of Operations Policy
• 208 Multicenter Clinical Trial Policy
• 301 Serious Adverse Events Reporting Policy
• 303 Interim Analysis Reporting Policy
• 306 Independent Data and Safety Oversight Policy
• 401 Conflict of Interest Policy
• 402 Regulatory Compliance & File Management Policy
• 403 Oversight by Institutional Review Board Policy
• 404 Manufacturer Expanded Access Policy
• 405 Posting to ClinicalTrials.gov Policy
• 406 Selection of IND or IDE Regulatory Filing Policy
• 407 Communications with the FDA Policy
• 408 Determining When to Prepare an Investigator's Brochure Policy
• 409 Single Patient Expanded Access Policy
• 410 Final Clinical Study Reports for Studies under CCR-held INDs or IDEs Policy
• 411 Emergency Exceptional Release of Product Policy

Policy Updates