Human Subject Research Resources

All Research – Series OTO-100

All investigators taking part in research involving human subjects must train on all of Series OTO-100

• OTO 100 –Institutional Review Board (IRB) Oversight
• OTO 101 – Informed Consent
• Attachment A – Assessing Comprehension of Informed Consent
• OTO 102 – Recognizing, documenting and reporting Adverse Events
• OTO 103 – Research Team Training
• Attachment A – Training and Educational Program Compliance Form​
• OTO 104 –OTO 104 - RECORDS MANAGEMENT AND RETENTION
• Attachment A – Protocol Training Log
• Attachment B – Delegation of Authority Log
• Attachment C - Study Personnel Log

FDA-Regulated Research – Series OTO-200

All investigators taking part in IDE or IND research must train on Series OTO-100 and OTO-200

• OTO 200 – Investigational Drug/Device Inventory Management
• Attachment A – OTO 200 Attachment A - Device Disposition Log
• Attachment B – Drug Disposition Log
• OTO 201 – Subject Screening and Recruitment
• Attachment A – Screening and Enrollment Log
• Attachment B – Inclusion and Exclusion Checklist
• OTO 202 – Subject Management While On Study​
• Attachment A – Medical History
• Attachment B – Physical Examination
• Attachment C – Concomitant Medications Logs
• Attachment D – Adverse Event and Intercurrent Illness Log
• OTO 203 – Quality Management and Corrective Action and Preventive Action Plans
• Attachment A – Meeting and File Review Plan
• Attachment B – CAPA Worksheet

Additional Standard Operating Procedures, as applicable – Series OTO-300

Investigators must train to the SOPs listed in Series OTO-300 only when they apply

• OTO 300 – Document Development and Change Control
• ​​Attachment A – Table of Modifications Form
• Attachment B – Document Approval Form
• OTO 301 – Gift Card Management
• Attachment A – OTO 301 Attachment A - Gift Card Tracking Form
• Attachment B – Gift Card Tracking Spreadsheet
• OTO 302 – Petty Cash Management
• OTO 303 – Electronic Gift Card Management
• ​Attachment A - Electronic Gift Card Tracking Form​​

Research Definitions and Acronyms

• Research Definitions and Acronyms