The Real World Data Program is designed to increase Health Authority confidence in Real World Data (RWD) / Real World Evidence (RWE) for regulatory decision-making.
- Tools To Consider When Engaging Health Authorities: Gaining internal sponsor cross-functional buy-in and alignment during study design on required inputs and decisions that need to be made in order to include RWD/E in regulatory decision-making.
- Considerations For Data Relevance and Reliability: Targeting data relevance and reliability to aid quality management oversight of RWD, including inspection readiness, in a manner suitable for regulatory decision-making.
Considerations For Data Relevance and Reliability
The RWD Audit Readiness Initiative is proud to present the white paper Assuring Audit and Inspection Readiness – Considerations for the Use of RWD and RWE in Regulatory Decision-Making.
Publish Date: December 2023
This list of key considerations for RWD quality has been developed to assist researchers interested in using RWD for regulatory decision-making. Its purpose is to provide greater clarity as to the type of information and documentation regulators may request from data providers and sponsors of research about the sources and process by which RWD/RWE is compiled to inform a regulatory decision. When used in conjunction with published guidance documents from regulatory agencies and other groups of experts, this document can help provide insights into what factors and circumstances may affect a health authority’s willingness to accept and use RWD as a basis for regulatory decision-making in the drug approval process.
Development of the Considerations White Paper Infographic
The RWD Audit Readiness Initiative has developed a complimentary infographic that depicts the process by which the set of audit readiness considerations were developed. The infographic summarizes the types of input collected (i.e. literature review, interviews, survey, public review) and the broad group of process stakeholders engaged who provided expertise in the collection and aggregation of real-world data.