Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines

► Standard safety data collection methods for pIMDs in clinical trials are proposed. ► pIMD lists and disease-specific standard questionnaires will enhance data collection. ► The theoretical risk period is at least 6 months, up to 1 year after the last dose. ► Baseline biomarker measurement could eventually provide valuable information. ► Standard case definitions are useful tools for establishing diagnostic certainty.