3. Advancing data quality for regulatory decision-making: A key tenet of the CRNs construct is the development and adoption of discipline-specific core minimum data in collaboration with regulators. this includes reaching agreement on precise definitions of data elements. consecutive data collection and completeness (minimising missing or out-of-range values) are important in producing robust medical device evidence and CRNs strive to achieve adequate enrollment with complete records of the target population. Coverage (ie, regional, national, health system etc.) is another important quality measure; and adequate coverage of hospitals and community practices within the scope of the registry is important for evidence generalizability.
Data Quality domain focuses on relevance, coverage (scale), completeness of patient enrollment and data elements (records) at both baseline and follow-up, and accuracy verified by periodic audits (ideally annually or at least every 2 years). These four concepts take into account the relevance and reliability concepts outlined in the real-world evidence guidance issued by the Centre for Devices and Radiological Health at the FDA. A key pre-condition for this domain is that the registry core minimum data elements and research modules are defined in collaboration with key stakeholders. This will ensure relevance because data elements with proper definitions and key stakeholder input are included in the data collection efforts (see also TPLC domain). Coverage (scale) concept is related to extent of participation of sites that use particular a technology/device. Completeness concept is related to how complete the enrollment is at each site and the core minimum data (records). Accuracy is defined by the degree of matching of the CRN/registry data to the source documents.	Level 1 Early Learner	The coverage includes the pilot registry/ CRN with single or several site efforts that capture small patient populations (data completeness and other quality measures are not yet relevant).
	Level 2 Making Progress	The coverage includes a large number of sites (large population) but mostly inadequate enrollment ii of patients but robust completeness iii of data elements (records). Plans are in place for conducting audits to assess and improve the data quality.
	Level 3 Defined Path to Success	The coverage includes a large number of sites engaged (large population), there is adequate enrollment ii of patients and completeness iii of data elements (records). Plans for conducting and executing audits of data quality at least once with minimum* requirements.
	Level 4 Well Managed	The coverage is at least regional or includes a large national health system with adequate enrollment ii of patients and completeness iii of data elements (records). Ongoing sequential audits with at least one audit completed with moderate* requirements.
	Level 5 Optimised	The coverage is national with adequate enrollment ii of patients and completeness iii of data elements (records). Initiating routine audits with extensive* requirements (at least bi-annual). *Auditing requirements: Minimum includes verification of at least exposure (eg, device) and outcomes using a generalizable cohort; moderate includes verification of exposure (eg, device), outcomes and key risk factors using a generalizable cohort; and extensive includes verification of entire data collection forms using a generalizable cohort.
ii Greater than 80% regional, national, or major health system coverage might be adequate; iii Greater than 80% enrollment with complete records might be adequate.