Valproate: survey on awareness of teratogenicity risk and impact of risk minimisation measures in women of childbearing age.

17/04/2026
03/11/2026
EU PAS number:
EUPAS1000000735
Study
Finalised

ENCePP Code of conduct

No information provided.
Data sources

Data source(s)

Data source(s), other

Patients selected from Belgian mutual insurance company databases.

Data sources (types)

Patient surveys
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Yes

Check completeness

Yes

Check stability

Unknown

Check logical consistency

Yes
Data characterisation

Data characterisation conducted

Yes

Data characterisation moment

after creation of study variables

Data characterisation details

Data from completed paper questionnaires were scanned and stored in a secure folder with restricted access. Questionnaire data were manually entered into SurveyMonkey by two members of the FAMHP, with data entry responsibilities split by questionnaire language (Dutch and French).
A quality check was subsequently performed by two other FAMHP members by comparing entered data with the original scanned questionnaires for a random sample of 10% of records. Identified discrepancies, if any, were resolved by reference to the source documents.
Following data entry verification, a first dataset was created in Excel. Data characterisation and quality checks were conducted to identify missing values, implausible values, and internal inconsistencies across questionnaire items. Predefined data cleaning rules were applied, in particular to address inconsistencies arising from skipping rules not respected by respondents.
The cleaned Excel dataset was independently quality checked by another FAMHP me
Procedures
No information provided.