|Parameter||Criteria of good Quality practice for Research|
|Purpose of the Registry||
-Research questions clearly defined|
-Meet the needs of key stakeholders
-The Registry should be an appropriate/the best means to achieve the purpose
|Study Design||Choice of study design which is more efficient for addressing the research questions: Cohort, Case-control or case-cohort.|
Relevance to the objectives of the registry|
Acceptability to subjects and researchersa
Use of standardized data collection form CDISC, CDASH, BRIDG when possible
Use of disease coding system ICD coding system, MIM, ORPHA codes
|Data sources (good quality means the use of the appropriate data sources to collect relevant data)||
Clinician:accurate and specific clinical data|
Patient:data on health-related quality of life, utilities (patient preferences), behavioral data, family history.
Electronic Health Record: information on routine medical care and practice, comprehensive view of patient medical and clinical history.
Linkage with other sources:data difficult to obtain, subject to recall bias, not collected because of loss to followup, or likely inaccurate by self-report.
- Patient selection: inclusion and exclusion criteriarelevant to the purpose|
- Patient sampling: consider representativeness in terms of patients and sites
|Registry size and duration||Calculation of target sample size and definition of the duration of enrollment and follow-up should consider the aims of the registry, the desired precision of information sought, and the hypotheses to be tested.|