Report with core data elements to collect long term outcomes

Task 23 Core data elements required for the prospective collection and followup of exposed pregnancies M136 UMAN NUTH UOSL LAREB UKZN ENTIS NVS Novo Nordisk Sanofi Teva BMS and WP7 partners This task has two key components1Describe and evaluate existing coding systems schemes and regulatory guidelines of reported medication exposed pregnancies M112 Building on existing EMA and FDA regulatory guidance documents such as ICH E2B R3 format for safety data exchange ICH M1 MedDRA international terminology IDMPSPOR and ENTIS and OTIS protocols for prospective cohort collection we will describe the requirements for spontaneous and solicited primary data collection format and coding and the possibility and methods to map existing formats to those standards in collaboration with WP7 Recommendations for changes to the current standards for data collection will be proposed where required following a gap analysis and assessment of content This task will receive input from the outcomes task force operational across WP1 2 and 7 to standardise and define data collection for assessment of key outcomes maternal foetal perinatal paediatric and stakeholder determined longer term outcomes to include eg neurodevelopment 2Define core data elements for assessment of acute and longterm outcomes eg neurodevelopment immunological cancer and potentially others M136 The recent valproate review and EMA scientific meeting on long term outcomes following pregnancy exposure have underscored the need to develop methods to assess risk of long term outcomes resulting from direct or indirect effects on reproduction Data elements considered necessary to study both acute and longterm outcomes will be established through literature review experience from recent global initiatives eg OTISVAMPSS an Expert Consultation Meeting and the crossWP outcomes task force WP1 2 7 The generated data elements will be tested and validated in demonstration projects see below and go through qualification advice by EMA Recommendations will be developed a for the standardisation of approaches to the collection of neurodevelopmental oncological and immunological data and b for the analysis of neurodevelopmental immunological and oncological outcomes in prospective data collection and in retrospective reports