Human Subject Research Resources
Professional Research Assistants
| University of Colorado Hospital | Children's Hospital Colorado |
Kristi Engle Folchert | Kaitlyn Tholen |
| Danielle Curtis Phone: (303) 724-8465 danielle.curtis@cuanschutz.edu | Ashley Jenkins Phone: (720) 777-8502 ashley.jenkins@childrenscolorado.org |
Laura Temple |
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 – Records Management and Retention
- Attachment A – Protocol Training Log
- Attachment B – Delegation of Authority 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
Faculty Development
Grant Opportunities
Grant Writing
Human Research Training Requirements
Institutional Review Boards
IRB
Office of Grants and Contracts
Optional Training
Regulations and Standard Operating Procedures
Statistics
UCH Review