Data Access - Center for Clinical and Translational Science

Contact

Jennifer Croker, PhD
Sr. Administrative Director, CCTS
jcroker@uab.edu

CCTS Informatics provides investigators with access to UAB electronic health record (EHR) data via either (1) our self-service tools (i2b2 and the Accrual to Clinical Trials (ACT) Network) or (2) an Electronic Data Warehouse (EDW) analyst.

CCTS Informatics offers three levels of clinical data:

Level 1 –
Summary Data

Aggregated patient counts; no Protected Health Information (PHI)
IRB approval for use is NOT required (per IRB protocol E160105006)*
Appropriate for cohort/enrollment feasibility, correlational studies
Accessible via self-service tools (i2b2 and ACT Network)

Level 2 – Limited (De-identified)
Detailed Data

Includes limited identifiers (dates and geographic locations larger than street addresses)
IRB approval for use is NOT required (per IRB protocol E160105006)*
Appropriate for recruitment or retrospective analyses
Accessible via i2b2 self-service tool

Level 3 – Fully Identified Detailed Data
(only accessible through an Analyst)

Patient-level data, with PHI
IRB approval required
Appropriate for recruitment or prospective

i2b2 Self-Service Data Access

	i2b2 Self-Service
Description	I2b2 (Informatics for Integrating Biology and the Bedside) is an NIH-funded National Center for Biomedical Computing based at Partners HealthCare System, that provides clinical researchers with self-service access to aggregates and HIPAA Limited Dataset derived from the electronic health record. This enables researcher determine the existence of patient set that meet certain criteria for cohort feasibility and analysis, respectively.
Data Type	Significant* reflection of EHR structured dataFact Types include allergy data, billed charges, biospecimen data, blood pressure, BMI and waist, cancer registry, clinical diagnosis, consult orders, diagnosis-related group (DRG), encounter insurance, encounter service, height, weight, immunizations, lab panels, lab powerplans, labs, medications, microbiology, select powernotes, problems, procedures (CPTs, ICD9/10), radiology events, social history, surgery data, etc.
Who can access	UAB Faculty and Staff, CCTS Partners (coming soon)
Patient Population	UAB Medicine
Results	HIPAA Limited Data Aggregate Counts
Downloadable	Yes
IRB Requirement	** No Individual IRB Approval required
Cost to Use	CCTS/Informatics Institute Supported
	i2b2 Login

EHR, Electronic Health Record; HCO, Healthcare Organization; PHI, Protected Health Information; PII, Personally identifiable information, HIPAA, Health Insurance Portability and Accountability Act; CTSA, Clinical and Translational Science Award(ee)

** Permitted Users, covered entities, and any Authorized Party on User's behalf listed in (Research Title/Grant Title) may use i2b2 self-service Limited Data Sets only for the purposes which shall be limited to research, public health activities, and health care operations as defined in the HIPAA Privacy Rule (per IRB protocol E160105006) and not for no other purpose.

Analyst-facilitated Data Access

	Analyst-facilitated Data Access
Description	The CCTS and Informatics Institute work together to provide robust data exports from the UAB Medicine electronic health record as guided by investigator-defined queries based on experimental design for secondary data analysis and to enable prospective recruitment for clinical investigation. The EDW houses mainly data that are extracted from Cerner (IMPACT) to support researchers during hypothesis generation, feasibility, preliminary data, grant submission, recruitment, and analysis. The EDW includes a wider breadth of data as compared to i2b2.
Data Type	EHR, inclusively
Who can access	Designated Informatics Honest Brokers provide data to anyone based on policy. IRB Protocol required for PHI or LDS data access
Patient Population	UAB Medicine
Results	PHI / PII HIPAA Limited Data Aggregate Counts
Downloadable	Yes (with assistance)
IRB Requirement	Approved Investigator-initiated protocol for PHI or LDS Datasets
Cost to Use	CCTS/Informatics Institute Supported; Budget in grants
	Data Request Form

TriNetX Research(TM) Data Access

	TriNetX Research™
Description	TriNetX Research™ is a suite of real-world data and analytics solutions for use in conducting observational and outcomes research. TriNetX Research combines longitudinal clinical data from its global health research network with powerful, state-of-the-art analytics on a single self-service platform.
Data Type	Limited Structured data (e.g., labs, meds, procedures, billing codes)
Who can access	UAB Faculty and Staff
Patient Population	UAB + over 70 HCOs, spanning 13 countries representing over 100 million patients.
Results	HIPAA Limited Data Aggregate Counts
Downloadable	Yes
IRB Requirement	None for Aggregate data. Approved Investigator-initiated protocol for HIPAA LDS data
Cost to Use	Free preparatory to research; Budget in grants
	Contact CCTS

N3C Data Access

	National COVID Cohort Collaborative (N3C)
Description	The N3C initiative creates a national, centralized, secure portal for COVID-19 research via secondary data analysis of clinical data. N3C is a partnership among several HHS agencies, the CTSA program, and the distributed clinical data networks PCORnet, OHDSI, ACT/i2b2, and TriNetX.
Data Type	Structured data related to COVID-19 (e.g., labs, meds, procedures, billing codes)COVID-19 related data (variable list continues to grow):• Person demographics (date of birth, gender, race, ethnicity)• Location (county, state, zip)• Observations (subject history including smoking status, alcohol)• Death (date of death)• Complete Visit History (begin and end dates, Inpatient/Outpatient)• History of Prescriptions (begin and end dates, doses, drug)• History of Device Exposure (X-rays, CT Scans, etc)• Condition Occurrences (All ICD9, ICD10 codes)• Measurement Histories (A1C, Glucose, Blood Pressure, Weight, BMI, Creatinine, etc)
Who can access	UAB Faculty, Staff and ***participating Institutions
Patient Population	UAB + over 50 HCOs
Results	HIPAA Limited Data Aggregate Counts
Downloadable	No
IRB Requirement	Approved Investigator-initiated protocol
Cost to Use	No Charge
	N3C Login

ACT Network Data Access

	ACT Network
Description	ACT (SHRINE) is HIPAA-compliant and IRB-approved self-service platform that enables cohort discovery using an open access to national network of leading academic medical research center. This tool enable researchers to generate aggregate de-identify patient count by querying across approved or partnered institutions electronic medical record systems based on an investigator’s real time iterative searches.
Data Type	Structured data (labs, meds, procedures, billing codes)
Who can access	UAB Faculty and Staff, CCTS Partners (coming soon)
Patient Population	UAB + over 40 CTSAs
Results	Aggregate Counts
Downloadable	Yes
IRB Requirement	**No individual IRB Approval required
Cost to Use	CCTS/Informatics Institute Supported
	ACT Network Login

*NOTE: It is possible that funding agencies or journal publishers may require documentation of IRB approval regardless of UAB IRB policy. If so, This email address is being protected from spambots. You need JavaScript enabled to view it. directly to request documentation of approval for Level 1 and Level 2 data sets.