Welche Neuerungen sich durch die Überarbeitung der DIN EN ISO 14155 ergeben und auf welche zusätzlichen Aufgaben müssen sich Sponsoren gefasst machen sollten.
This is not to say we should do as we always did. This is also not to promote unnecessarily frequent monitoring visits or a 100% source data verification (SDV). However, in times were risk-based quality management including centralized monitoring are in the regulatory focus, I feel we forget to reflect the undeniable value that on-site monitoring can give to a clinical study [...]