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Vice Chancellor for Health Sciences VCHS
  1. VCHS
  2. Administration
  3. Senior Associate Vice Chancellor (SAVC) for Health Sciences
  4. Offices
  5. OCR
  6. SOPs

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 (PDF)

OCR-002 Informed Consent Process (PDF)

OCR-003 Protocol Development and Review (PDF)

OCR-004 Institutional Review Board (IRB) Submissions (PDF)

 OCR-005 Research Participant Recruitment Procedures (PDF)

OCR-006 Study Participant Registration (PDF)

OCR-007 Conflict of Interest Management (PDF)

OCR-008 Data Collection and Management (PDF)

OCR-009 Safety and Adverse Event Reporting (PDF)

OCR-010 Monitoring and Quality Assurance (PDF)

OCR-011 Delegation of Authority (PDF)

OCR-012 Investigational Product Handling (PDF)

OCR-013 Study Closeout and Reporting (PDF)

OCR-014 Training Requirements (PDF)

OCR-015 Publication and Authorship (PDF)

OCR-016 Clinical Research Space Management (PDF)

OCR-017 Financial Coverage Analysis (PDF)

OCR-018 Research Financial Management (PDF)

OCR-019 Clinical Emergencies Management (PDF)

 

 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)