Proposed Contents of a Real-World Data Quality and Relevance Package for Regulatory Submissions

Real world data is increasingly used for regulatory decisions. Based on regulatory guidance documents on data quality and relevancy for real world data, TransCelerate released considerations for audit readiness in 2023. However, the content and level of detail for the actual documentation needed for real world evidence submissions to the Food & Drug Administration are unclear. A group of leaders from the International Society for Pharmacoepidemiology, the Professional Society for Health Economics and Outcomes and Research, and TransCelerate leaders convened to develop a tangible view of a data package justifying real world data relevance and data quality for implementing a real world evidence protocol. Depending on specific data needed for the research question and regulatory decision, each real world data source - evaluated for feasibility - must be described, including the type of data, its accuracy and completeness, adequacy in capturing study variables, details of the data processing and extraction, transformation and loading documentation, as well as audit trails and ideally, traceability to the source. A dynamic framework was developed to highlight pertinent details needed for regulators to fully review a real world evidence submission from a data quality and relevancy viewpoint. These details should help researchers understand the documentation needed to justify the evaluation and selection of real world data sources to address a specific research question and regulatory decision. In addition, data providers can use it to clarify what their customers need for regulatory submissions including real world data, and to remind regulators what documentation they may wish to request.