Clinical Data Registry

Sources and review notes

These links support definition-level research and do not establish the regulatory status, safety, or suitability of any product.

AHRQ describes a patient registry as an organized system using observational methods to collect data for scientific assessment of patient outcomes and provides guidance on registry purpose, design, data elements and sources, ethics, privacy, linkage, quality assurance, analysis and evaluation. FDA's Advancing Real-World Evidence Program identifies registries as one possible real-world data source and highlights relevance, reliability, timing, completeness, integrity, validation, linkage and source-record access. CMS's Quality Payment Program separately recognizes Qualified Clinical Data Registries and Qualified Registries as third-party intermediaries for specific MIPS collection and submission workflows; that program label is not a universal definition of a clinical registry. A registry's existence does not establish representative data, unbiased estimates, regulatory acceptance, valid quality reporting or clinical fitness. Teams must document purpose and governance, population and site coverage, inclusion and exclusion criteria, consent or other authority, source systems and provenance, data dictionary and versions, patient and encounter matching, missingness and duplicates, validation against source records, quality thresholds and corrections, privacy and security, retention, participant rights, measure specifications, analysis plan, conflicts, access and sharing controls, auditability, and limits on clinical, research, reporting and commercial reuse.

• Source 1: effectivehealthcare.ahrq.gov/products/collections/advancing-registry-methodology-and-transparency
• Source 2: effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/ehc-registries-users-guide-third-edition-second-addendum.pdf
• Source 3: www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program
• Source 4: qpp.cms.gov/get-started/what-is-mips/data-collection-and-submission