Journal of Developing Drugs
Open Access

Ending the clinical IT lifecycle with decommissioning of GCP clinical data

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Jesper Ilm

Accepted Abstracts: J Develop Drugs

Abstract :

Any clinical IT system will eventually end the journey in its lifecycle. But when decom-missioning the IT system - what to do with data that are managed and controlled by the system? Based on an actual case, this presentation will detail how a statistical computing envi-ronment used for clinical research analysis was decommissioned, and provide an overview of the considerations made during the process. Specific areas of interest were: Clinical data: By adopting a risk based approach, the project needed to decide what data to keep avail-able - and what data to delete Software, users and configuration: How to decommission software, user access and configurations - with particular focus on relevant regulations Documentation: All documentation generated throughout the clinical IT systems? lifespan needs to be as-sessed, and by adopting a risk based approach it needs to assessed what to keep and what to make obsolete Audit trail: Considerations about the audit trail - what to do with this type of essential data? The presentation will outline the approach used by the project Hardware: How to decommission any hardware used by the IT system - and why is it important to take this into account