Regulatory Services
Navigating the Regulatory Framework of Clinical Research
Regulatory coordinators provide support for both industry sponsored and investigator-initiated clinical trials
for review of Institutional Review Board (IRB), Food and Drug Administration (FDA), and other compliance
submissions, ensuring completeness of requirements and inclusion of all required documentation.
![](https://clinicaltrials.uwmedicine.org/wp-content/uploads/2022/07/Regulatory_448177739_1080x480.jpg)
Our regulatory coordinators support the Principal Investigator by facilitating and coordinating protocol activities including:
- Prepare and submit IRB applications (initial, continuing review, amendments)
- Prepare and submit for institutional approvals
- Protocol development – assist drafting investigator-initiated protocols
- Develop, draft, and edit study forms and materials
- Ensure compliance with federal and state regulations and institutional recommendations/guidance
- Review written study procedures and draft data collection forms
- Create and maintain regulatory binders to meet sponsor and federal regulatory requirements
- Ensure compliance with ICH E6 Good Clinical Practice and Code of Federal Regulations requirements