Table 2.

Proposals on data elements and data quality attributes necessary in patient registries and on the operational measures required for implementation

Topic	Proposals	Operational measures required
Core common data elements	Core common data elements to be collected by all contributing registries in a specific disease area	Agree on the core common data elements to be included in specific disease area registries, including the associated definitions and data dictionaries
	Harmonise data element definitions across registries	Provide data element definition information or source to stakeholders
	Agree on core PROs that could feasibly be collected systematically	All stakeholders to collaborate on defining PROs (appropriate as necessary for patient age, capacity, language, and for caregivers)
Data quality	Indicators on data consistency, accuracy and completeness to be implemented and reported	Registries to publish at agreed intervals reports or audits of data quality

Quality components	Indicators of quality	Operational measures required
Consistency:  Uniformity of the data over time (e.g. laboratory data routinely entered)	Proportion of data fields changed over time Proportion of fields missing over time	Audits and centre level data checks Standard terminology and coding Standard operating procedures Registry data entry dashboard
Accuracy:  Accuracy of data entry—no errors, contradictions or impossibilities in the data  Absence of duplicates	Change in value of data filed by x% creates alerts Variability of data values across common fields	Drop down menus, alerts, text prompts Validate registry data sample (e.g. 10%) against source data Software checks Staff training Help screens/desks Funding for data managers
Completeness:  Proportion of data missing  Absence of core variables	Agreed % of fields completed in audit procedures (e.g. > 90%) Proportion of patients lost to follow-up/attrition rates Minimum agreed core common data elements reported All treated patients reported, not selected patients only	Audits Mandatory fields Agreement on entry of ‘not done’ or ‘null’ values Engagement with patients and HCPs Agreed list of data elements and definitions Cross-check patient numbers with numbers of products used at treating centres (applicable for some advanced therapies)

HCPs healthcare professionals, PROs patient reported outcomes