Training Course & Event Calendar
How long should your Clinical Trial Computerised Systems be kept online?
Course Date: October 26, 2023
Type of Course: Hot Topic
Course Trainer: Alan Yeomans (Viedoc)
Location of Course: Online 12:00-13:00 UK Time
Learning Objectives:
Who is the Course Suitable For?
ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management
Outline Course Content
The use of electronic tools and platforms to drive data collection during clinical trials has brought associated challenges with regard to both the long-term retention of data and the ability to reinstate decommissioned computerised systems, whether or not such systems are in use across multiple trials or deployed for use in a single trial. Computerised systems are now frequently developed, hosted and managed by third parties on cloud infrastructure as opposed to residing in dedicated data centres. Regardless of the technical environments such computerised systems reside in, factors such as security, cost, maintainability, and vendor support all play into the ability to restore legacy systems (or software releases), whilst similar considerations apply to access to archiving data formats. In conjunction with EUCROF, the eClinical Forum has evaluated the archiving landscape and prepared industry white papers on The Decommissioning of Computerised Systems Used in Clinical Trials and Data Formats Used in Clinical Trials. These white papers elaborate the options, risks, and benefits of using a flexible system agnostic, multiformat approach to retaining data/metadata into the long term. This presentation will discuss the timing of system decommission, the viability of data formats and the inherent benefits of standards.
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