Appendix B. Causality as reported rules
Tip
The auto-population rules for Causality as Reported are provided as an example. The rules can be customized per the sponsor's request by the EDETEK administrator.
|
Priority |
Method of Assessment |
Source of Assessment |
Result of Assessment |
Mapping Result |
|---|---|---|---|---|
|
1 |
FDA |
Investigator |
Related |
Related |
|
2 |
FDA |
Investigator |
Not Related |
Not Related |
|
3 |
EU Method of Assessment |
Investigator |
Related |
Related |
|
4 |
EU Method of Assessment |
Investigator |
Not Related |
Not Related |
|
5 |
EU Method of Assessment |
Health Care Professional |
Related |
Related |
|
6 |
EU Method of Assessment |
Health Care Professional |
Not Related |
Not Related |
|
7 |
EU Method of Assessment |
Health Care Professional |
Related |
Related |
|
8 |
EU Method of Assessment |
Health Care Professional |
Not Related |
Not Related |
|
9 |
NMPA |
Investigator |
Certain/Definite |
Related |
|
10 |
NMPA |
Investigator |
Probable/Likely |
Related |
|
11 |
NMPA |
Investigator |
Possible |
Related |
|
12 |
NMPA |
Investigator |
Unlikely |
Not Related |
|
13 |
NMPA |
Investigator |
Unassessible/Unclassifiable |
Not Related |
|
14 |
NMPA |
Investigator |
Conditional/Unclassified |
Not Related |
|
15 |
NMPA |
Health Care Professional |
Certain/Definite |
Related |
|
16 |
NMPA |
Health Care Professional |
Probable/Likely |
Related |
|
17 |
NMPA |
Health Care Professional |
Possible |
Related |
|
18 |
NMPA |
Health Care Professional |
Unlikely |
Not Related |
|
19 |
NMPA |
Health Care Professional |
Unassessible/Unclassifiable |
Not Related |
|
20 |
NMPA |
Health Care Professional |
Conditional/Unclassified |
Not Related |
|
21 |
NMPA |
Non-Health Care Professional |
Certain/Definite |
Related |
|
22 |
NMPA |
Non-Health Care Professional |
Probable/Likely |
Related |
|
23 |
NMPA |
Non-Health Care Professional |
Possible |
Related |
|
24 |
NMPA |
Non-Health Care Professional |
Unlikely |
Not Related |
|
25 |
NMPA |
Non-Health Care Professional |
Unassessible/Unclassifiable |
Not Related |
|
26 |
NMPA |
Non-Health Care Professional |
Conditional/Unclassified |
Not Related |