Additional Resources
Guidance
- Administrative Closure Guidance
- Adobe Sign (FAQs)
- Adverse Event Guidance
- CITI Training Instructions
- ClinicalTrials.gov Flow Chart
- ClinicalTrials.gov Requirements
- Key Personnel Defined
- PHI Guidance
- Policy & SOP Center (for BRI personnel)
- Recruitment Material Guidance
Templates/Forms
- Applicable Clinical Trials Flow Chart
- Emergency Use Drug or Device
- Individual Investigator Research Data Collection and Sharing Agreement
- Protocol Template
- Waiver of Authorization for Use and/or Disclosure of Protected Health Information (“PHI”) for Research
- Waiver for Recruitment of VM Patients for Research by Non-VM/BRI Staff Form
- HIPAA - Report breaches to the Privacy Officer at 206-223-7505