Regulatory and Ethics Approval (Milestone)
Description
Regulatory & Ethics Approval signifies all legal and ethical requirements for the study have been reviewed and are acceptable. No site-related study conduct activities can be performed prior to achieving this milestone.
The study, its associated conduct plans, and any patient facing materials are approved for use to conduct the study at the investigational site.
Metrics Considerations
Date of Regulatory and Ethics Approval may be important for cycletime KPIs such as time to FPI, LPI.