Work package 15: Quality assurance, evaluation and validation

Brief description and aims of work

Following from the different goals and requirements defined within the various WPs, also the criteria and approaches to assure, evaluate and validate quality have to vary accordingly: The spectrum ranges from testing software components and services, such as the standardized access to heterogeneous data sources or the patient empowerment tools, up to the performing of clinical trials. Hence, this WP will identify objectives that need to be specifically tested in each case, define the proper evaluation criteria and devise monitoring procedures that will be executed. This WP is crucial in that it will continuously assess the quality of all services and tasks of the p-medicine environment and iteratively gives feedback to all responsible persons. It will initially create in the first 18 months a set of guidelines and check-lists to support evaluators in setting-up their evaluation reports. These reports in turn will provide issues and suggest possible improvements, modifications and other functionalities. Furthermore, workshops are to be held to perform dedicated evaluation sessions
engaging both users and developers. Besides these task-specific evaluations, another task is to provide
combined evaluations covering the whole integrated p-medicine environment. Specifically, this WP:

• Formulate evaluation criteria, verification procedures, and feedback report guidelines
  
• Coordinate validation activities by partners and feedback reports
  
• Evaluate the developed software tools by testing functionalities, accessibility, respect of user needs, data
  integration and execution times
• Verification of GCP (Good Clinical Practice):
  • protection of human rights as a subject in clinical trial
    
  • standards on how clinical trials should be conducted
    
  • clinical audit: performance will be regularly reviewed to ensure scheduled activities will be properly executed
• Survey of certification criteria for software components in clinical research settings and evaluation of their
  adherence in p-medicine environment
  
• Write a final evaluation report

Work package leader

•  WP 14
• WP 16