Template SOPs
The template SOPs on this page have been developed by the OCR as a minimum standard for compliance. The SOPs may be adopted by a CRU without modification, or they be modified by adding details to the SOP to cover specific operational requirements. Content may not be removed from the template SOPs or reworded without permission from the OCR director.
If you require any of the documents in an editable format, please email ocr@health.ucsd.edu
Standard Operating Procedures (SOP)
OCR-001 Study Team Roles and Responsibilities
OCR-002 Informed Consent Process
OCR-003 Protocol Development and Review
OCR-004 Institutional Review Board (IRB) Submissions
OCR-005 Research Participant Recruitment Procedures
OCR-006 Study Participant Registration
OCR-007 Conflict of Interest Management
OCR-008 Data Collection and Management
OCR-009 Safety and Adverse Event Reporting
OCR-010 Monitoring and Quality Assurance
OCR-011 Delegation of Authority
OCR-012 Investigational Product Handling
OCR-013 Study Closeout and Reporting
OCR-015 Publication and Authorship
OCR-016 Clinical Research Space Management
OCR-017 Financial Coverage Analysis
OCR-018 Research Financial Management
OCR-019 Clinical Emergencies Management
OCR-020 Standard Operating Procedures
Templates, Logs, and Checklists
OCR-101 NIH Sample Informed Consent Process Checklist (Word)
OCR-102 Sample Screening and Enrollment Log (Word)
OCR-103 MRN Request Checklist (Word)
OCR-104 FDA Inspection Checklist (Word)
OCR-105 Protocol Deviation Tracking Log Template (Word)
OCR-106 AE Log Template (Word)
OCR-107 Delegation of Authority Log (Word)
OCR-108 Sample Training Log (Word)
OCR-109a - Sample Investigational Agent Accountability Log (Word)
OCR-109b - Sample investigational Agent Device Accountability Log (Word)
OCR-109c - Sample Investigational Product Accountability Log (Word)
OCR-110 - Research Charge Adjudication Checklist (Word)
OCR-111 - Sample Co-Author Agreement (Word)
OCR-112 - Sample Closeout Checklist (Word)
OCR-113 - HIM Upload Cover Page (Word)