Table 3.
Designing a new registry with the capability of embedding a clinical trial.
| Requirements | Recommendations |
|---|---|
| Clearly articulate the concept of the registry in a transparent manner | The registry design document should articulate the vision, mission, reason, and value proposition of the registry |
| Define and describe participant characteristics |
The registry must minimize barriers for inclusion, thus maximizing inclusion of those having the disease/condition to be studied. The registry must allow for disparate treatment modalities, including drugs, biologics, devices, and combination products |
| Select clinically relevant data elements |
Data elements should efficiently capture and convey information in order to provide evidence based on meaningful clinical endpoints and outcomes Definitions used for data elements should conform to recognized standards and nomenclature There must be the ability to: Document informed consent Document randomization/assignment of patients Configure/add additional data elements There should be the ability to: Identify clinically eligible patients for trial participation Accept external data if not collected in the registry (e.g., EHR, reliable external datasets) Measure product performance Document adjudication or core lab determinations for key trial outcomes |
| Data collection processes must be systematic, consistent, reproducible, and reliable |
The registry must be 21CFR Part 11 compliant Data traceability must include attributability of data originators and data entry personnel, with date and time stamps for all transactions Data should be usable for clinical care purposes Data collection should be integrated into the process of care All processes must be supported by documented training and education of those entering data (e.g., data managers, data entry personnel, and registry participants) |
| Assure the registry conforms to informatics standards |
The registry should support: Publication of the data dictionary Defined and semantic interoperational data elements Use of common data elements/controlled vocabularies Use of a common data model Use of the FDA’s UDI, if device Referential integrity via use of single source (e.g., RxNorm, GUDID) |
| Evaluate and assure data quality across multiple dimensions | The data must be contemporaneous, accurate, legible, consistent, complete, and reliable |
| Patient protections must be assured |
Assure patient protections by including the following elements: Documentation of appropriate informed consent Data confidentiality policies System security compliance and security audits Published explanation of intentional data uses Training of data originators (i.e., data entry personnel) and managers IRB oversight and review |
| Assure registry design is valid across multiple stakeholder analyses |
Data should support pre- and post-market regulatory as well as other stakeholder evidentiary needs Data ownership and access to trial-specific data should be established prior to the start of an embedded trial (e.g., processes for sequestration of trial data from the full registry data and access limitations prior to product approval). For site-based users, the registry should support: Quality assurance and performance improvement Risk reduction Benchmarking based on risk-adjusted outcomes Anticipate distributed query and aggregate analysis |
| Incorporate patient-reported information within the registry |
Provide guidelines for participants in reporting to the registry Provide technologies/structures to support the systematic, periodic query of participants |
CFR code of federal regulations, UDI unique device identifier