Basics
What is the primary purpose of a coverage analysis amendment in a clinical trial?
To modify coverage determinations and study structure based on new protocol or study document
The amendment adds an MRI at screening. Does the CA need review/revision?
Yes
True or false: Every protocol amendment requires a completely new coverage analysis
False
The amendment removes an ECG at screening. What should happen to the CA?
Remove time point and review analysis for necessary updates
What does SoA stand for?
Schedule of Activities
The protocol amendment states that the patient population is increasing from 10 patients to 35 patients. Is a CA revision required?
No
What two final versions of coverage analysis are needed in the study folder
Clean version, redlined version
The amendment changes a lab from weekly to every 3 weeks. What should you update?
Update time points, update analysis to adjust to new frequency
What section should you review first when reviewing an amended protocol? (if it is available)
Summary of Changes
The protocol amendment removes ALT and potassium from the chemistry labs. Is a CA revision required?
No, we still bill the panel