ConcePTION has brought together industry, academic and clinical experts with extensive experience in conducting pregnancy medication safety research. Together, they set out to develop a reference framework describing the core data elements which should be collected in primary source pregnancy medication safety studies.
You can now access the resource via the results section on the ConcePTION website, and read about the resource in a paper published in Drug Safety earlier this year. The finalised framework is made up of 98 individual data elements, arranged into 14 tables of related fields. The index and tables are searchable, and and tables can be filtered by whether the data elements are considered absolutely essential or not.
Take a look: ConcePTION core data elements for pregnancy pharmacovigilance