TABLE 4.

Key Elements of the CARRA Registry and CARRA-CoRe Data Architecture

Data Flow	Key Features
Data entry and imports	The CARRA Registry has for FDA 21CFR11 compliant site data entry using an electronic data capture system and, at certain sites, electronic health record data transfer.
	Subjects are consented at each site.
	Contact information and copies of informed consents are maintained in the Consent and Contact Database that is managed by the Long-Term Follow-up Group at the DCRI.
	Access to clinical data and contact data are separated by a Personal Identifiers Firewall (at both organizational and electronic levels) to ensure privacy and protect the usage of contact and personal health information.
	Patient-reported outcomes and surveys are collected and entered into the electronic data system or entered directly by subjects.
Data exports	Imported data are securely routed to site-specific i2b2 datamarts corresponding to the originating sites.
	Multiple virtual i2b2 databases are hosted on a central i2b2 server “farm,” allowing scalability to add sites, other sources of data entry, or specific projects such as CARRA-CoRe.
	Permissioned sharing of data is governed through the Shared Health Research Information Network.
	The CARRA Registry i2b2-Self Scaling Registry Query Aggregator and User Interface permits each site to query its own CARRA Registry data.
	Permissioned investigators can perform network queries to access and analyze aggregated data across 2 or more network sites.
	CARRA-CoRe has a virtual i2b2 datamart incorporating data imports from the CARRA Registry with additional CARRA-CoRe-specific fields.
	Additional data from review of medical records for serious adverse events or prespecified important medical events are entered into the CARRA-CoRe datamart.
	Additional linked data sources are added as appropriate to the CARRA-CoRe requirements.
	CARRA-CoRe queries can provide multiple opportunities for primary and secondary analyses relevant to pharmacoepidemiology, adverse events, medication safety, and other areas of interest.