Policies & Standard Operating Procedures
The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.
This stage includes activities in areas such as:
- contracts & grant proposals
- IRB approval
- research management compliance
- study budgeting & billing
- required registration of trial
- Stanford Human Research Protection Policy (HRPP)
- Research Policy Handbook (RPH)
- Human Subjects Research Guidances
Medicare IDE Preauthorization
- Contact the Research Process Manager assigned to your department. Research Management Group
- Medicare preauthorization for medical device studies – For assistance, contact your RPM.
- Medicare coverage for routine care costs of qualifying clinical trials National Coverage Decision