Additional Services (as Requested and Approved)
- Protocol review, input, and edits
- Protocol risk assessment
- Protocol monitoring plan review, input, and edits
- Ongoing coordinator Q&A
- Case Report Forms review, input, edits
- Deviation reporting consultation and assistance
- Deviation root cause analysis and CAPA consultation and assistance
- Source data review and verification (EDC review and verification)
- Staff training on any of the services provided or clinical research compliance topics.
Email: CRSOQA@hsc.utah.edu