Box 1.

Nature of the data collected and registry quality assurance processes

Workshop participants’ recommendations included:

‘Agree on standards for data quality indicators, terminologies/coding and reporting requirements to apply to national registries and to the ECFSPR’ (European Cystic Fibrosis Society Patient Registry) [17].

‘Agreement on the data elements to be collected in MS (multiple sclerosis) registries would facilitate treatment evaluations and comparisons of safety and effectiveness outcomes between different MS populations and across multiple countries’ [18].

‘Established quality standards should be in place and adequate for all registry studies; a dedicated data control and follow-up system should be introduced only for very specific studies or where the existing system is not [yet] adequate’ [19].

‘Definitions for the data elements required by the FVIII Guideline need to be agreed and applied across treating centres and registries; the associated data dictionaries need to be established and maintained’ [20].