Current Edition

The Changing Organisation and Data Management Roles

Resource Roles Revisited for New Optimisation (Part 1)
Anyone who has been involved in clinical development and data management (DM), in particular for a long period of time, will recognise how the organisation of staff to perform the wide range of data collection and management tasks has changed to better align with advancements in technology. Joette Keen, Head of Biometrics & Clinical Data Execution Systems at KCR, discusses the pre-electronic data capture (EDC) era, when all trials, regardless of size, collected data on paper case report forms (CRFs). This method had a long lifespan, and as such had quite established practices whichalso drove operational organisation.