Validation activities represent a cornerstone of quality and patient safety in HCT and cell therapy programs, yet their implementation across centers may vary significantly in terms of scope, depth, and risk-based application.
The increasing complexity of advanced therapies, together with the requirements introduced by JACIE 9th Edition Standards and EU GMP Annex 15, has highlighted the need for a clearer understanding of how validation principles are interpreted and operationalized at center level.
This survey aims to:
• map current validation practices across EBMT centers,
• identify areas of convergence, variability, and potential gaps,
• highlight pragmatic and risk-based approaches already in use,
• support benchmarking and shared learning within the EBMT/JACIE community.
The survey will be conducted in an anonymous and anonymized manner. No center-identifiable data will be collected or reported, and results will be presented exclusively in aggregated form.
Estimated completion time: approximately 5-10 minutes.
The survey is not intended as an audit or compliance assessment, but as a tool to inform future guidance, training needs, and potential harmonization initiatives, fostering a proportionate and sustainable implementation of validation requirements in both clinical and laboratory settings.