Core data elements for pregnancy pharmacovigilance
Evidence about the safety of using medicines in pregnancy is generated from a number of different data collection systems, each with their own slightly different approaches. This can make it difficult for researchers to make sense of information that is combined from different studies. Developing data collection standards for researchers studying the safety of medicines in pregnancy may help with combining data from different studies. In turn, this could allow for a faster accumulation of useful evidence that can be used to inform healthcare professionals and women about medication safety in pregnancy.
As part of work package 2 of the IMI ConcePTION project, industry, academic and clinical experts with extensive experience in conducting pregnancy medication safety research set out to develop a reference framework describing the core data elements which should be collected in primary source pregnancy medication safety studies.
The framework was produced through first identifying the data elements that were collected in existing and well-established pregnancy medication safety data collection systems. All relevant data elements were then defined, a suggested data structure was developed, and how these data variables worked with one another was established. A decision about which of the variables were absolutely essential to be collected was also made.
A full description of the development of this framework has been published in Drug Safety: Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project
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.
- Searchable list of all data elements with their corresponding table (index)
- Table 1: Database management details
- Table 2: Maternal details
- Table 3: Pregnancy details
- Table 4: Maternal medical history details
- Table 5: Family medical history and obstetric history details
- Table 6: Pregnancy medication exposure details
- Table 7: Maternal illness and obstetric complication details
- Table 8: Pregnancy outcome details
- Table 9: Delivery details
- Table 10: Live/stillborn birth outcome details
- Table 11: Live born neonatal/infant outcome details
- Table 12: Malformation details
- Table 13: Longer-term child health outcome details
- Table 14: Longer-term child neurodevelopmental outcome details