Appendix D. Case causality rules
Tip
The auto-population rules for Case Causality are provided as an example. The rules can be customized per the sponsor's request by the EDETEK administrator.
|
Priority |
Event Selection |
Causality As Reported |
Logic |
Causality As Determined |
Mapping Result |
|---|---|---|---|---|---|
|
1 |
Any Serious Event Only |
Related |
Or |
Related |
Related |
|
2 |
All Serious Event Only |
Not Related |
And |
Not Related |
Not Related |
|
3 |
Any Event When All Events Non-Serious |
Related |
Or |
Related |
Related |
|
4 |
All Event When All Events Non-Serious |
Not Related |
And |
Not Related |
Not Related |
|
5 |
Any Event |
Related |
Or |
Related |
Related |
|
6 |
All Events |
Not Related |
And |
Not Related |
Not Related |