The collection of high-quality data requires a standardized procedure. We will therefore apply electronic case report forms implemented in “Askimed” (http://www.askimed.com).
Askimed is an intuitive and self-explaining researcher-supporting software solution that allows a standardized data collection with extensive checking of plausibility as part of the quality control management. It is already in use in the German Chronic Kidney Disease Study (http://www.gckd.de/), the FP7-funded ncRNAPain project (http://www.ncrna-pain.eu/) and in a large study including patients with macular degeneration (AugUR study).
All data are securely transferred to a centralized MySQL database. The Medical University of Innsbruck will provide this centralized database for storage of data considering all security issues of importance for such a project. This includes that all interactions with the server and the database are encrypted. Furthermore, Askimed is compliant to the 21 CRF Part 11 regulations (FDA guidelines on electronic records and electronic signatures). The questionnaires will be programmed by the Innsbruck team, a database will be provided and – if requested – the questionnaires can be prepared in the most widely-used languages. The consortium will be owner of the data and access will be allowed according to the rules of the consortium.