Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling.

20/10/2010
19/07/2016
EU PAS number:
EUPAS1594
Study
Finalised

ENCePP Code of conduct

No
Data sources

Data sources (types)

Spontaneous reports of suspected adverse drug reactions
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No