Abstract
The pilot phase of the ECRIN (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012. The pilot phase, the conclusions drawn from it and the revised set of standards are described. Issues concerning the further development of standards and related material are discussed, as are the methods available to best support that development. A strategy is outlined based on short-lived specific task groups, established as necessary by a steering group drawn from ECRIN-ERIC. A final section discusses possible future developments.
Highlights
The pilot phase of the the European Clinical Research Infrastructures Network (ECRIN) (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012
That would increase the attractiveness of ECRIN certification, and means that units may wish to use the standards in a self-assessment exercise, for example to help prepare for inspection, which in turn means that ECRIN should consider developing the necessary materials and proformas to support self-assessment
It has been possible to provide a substantial revision of the ECRIN standards following a successful pilot of the original standards and the audit process
Summary
The pilot phase of the ECRIN (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012. The major recommendation, was that the standards themselves needed extensive revision, to provide a clearer and more widely understood basis for centre certification, a better basis for individual auditors to interpret the standards, and a better guide to good quality IT and data management in non-commercial trials units.
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