This survey aims to assess stakeholders’ awareness about the Guideline on registry-based studies, to identify specific topics requiring clarification, and to understand training needs.
The Guideline was endorsed by the Committee for Medicinal Products for Human Use (CHMP) and published on the European Medicines Agency (EMA) website in October 2021 following two extensive public consultations.
It provides recommendations on key methodological, regulatory and operational aspects specific to the use of patient registries to conduct registry-based studies to support regulatory decision-making. These aspects include considerations on the definition of study populations, design of study protocols, data collection, data quality management and data analysis to achieve higher quality evidence.
The document also includes an annex highlighting good practices in the establishment and management of patient registries and their use for other possible regulatory purposes.
Based on the survey results, EMA will develop specific communication and training materials tailored to the different stakeholder groups as needed, in order to ensure appropriate awareness and application of the Guideline.We will appreciate your feedback by 15 June close of business.
To access the survey, please follow this link
