Appendix C. Causality as determined rules
Tip
The auto-population rules for Causality as Determined 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 |
Sponsor |
Related |
Related |
|
2 |
FDA |
Sponsor |
Not Related |
Not Related |
|
3 |
FDA |
Marketing Authorisation Holders |
Related |
Related |
|
4 |
FDA |
Marketing Authorisation Holders |
Not Related |
Not Related |
|
5 |
EU Method of Assessment |
Sponsor |
Related |
Related |
|
6 |
EU Method of Assessment |
Sponsor |
Not Related |
Not Related |
|
7 |
EU Method of Assessment |
Marketing Authorisation Holders |
Related |
Related |
|
8 |
EU Method of Assessment |
Marketing Authorisation Holders |
Not Related |
Not Related |
|
9 |
NMPA |
Sponsor |
Certain/Definite |
Related |
|
10 |
NMPA |
Sponsor |
Probable/Likely |
Related |
|
11 |
NMPA |
Sponsor |
Possible |
Related |
|
12 |
NMPA |
Sponsor |
Unlikely |
Not Related |
|
13 |
NMPA |
Sponsor |
Unassessible/Unclassifiable |
Not Related |
|
14 |
NMPA |
Sponsor |
Conditional/Unclassified |
Not Related |
|
15 |
NMPA |
Marketing Authorisation Holders |
Certain/Definite |
Related |
|
16 |
NMPA |
Marketing Authorisation Holders |
Probable/Likely |
Related |
|
17 |
NMPA |
Marketing Authorisation Holders |
Possible |
Related |
|
18 |
NMPA |
Marketing Authorisation Holders |
Unlikely |
Not Related |
|
19 |
NMPA |
Marketing Authorisation Holders |
Unassessible/Unclassifiable |
Not Related |
|
20 |
NMPA |
Marketing Authorisation Holders |
Conditional/Unclassified |
Not Related |