1. Protocol Deviation Handling
Omar Hamidi, Clinical Project Data Manager

2. Protocol Deviation Handling
Process
Define list of important PDs
Identify, classify and document PDs
Process PDs
Review and update
Root cause analysis, if applicable
Trending

3. Protocol Deviation Handling
Define list of important PDs
Trial-specific list
Template from SOP
Defined by clinical trial team

4. Protocol Deviation Handling
Identify, classify and document PDs
Monitor identifies PDs
Automatic checks identify potential PDs
PDs identified by others are communicated to monitor
Classify as important or non-important
Document in PD log

5. Protocol Deviation Handling

6. Protocol Deviation Handling
Auto
Monitor
Auto

7. Protocol Deviation Handling
Process PDs
Process PDs
Review and update
Root cause analysis, if applicable
Trending

8. Protocol Deviation Handling
Trial Manager

9. Protocol Deviation Handling
Process PDs
Print
Individual – PDF
Complete log - Excel

10. Protocol Deviation Handling
Process PDs - Trending

11. Protocol Deviation Handling
Process PDs - Trending