Matthew J. McAuliffe, PhD

Chief, Biomedical Imaging Research Services Section (BIRSS) CIT

Using BRICS & CDEsto

Accelerate Biomedical DiscoveryThrough Data Sharing

http://brics.cit.nih.gov/

Why share data?

To Ask New Questions

To Accelerate Discovery

To Replicate Experiments

To Stimulate Discussion

To Model Data

To Visualiz

e

To Learn

To Teach

To Efficiently use

Resources

BRICS Modules

Study Management and Data Submission

• Defines and manages study information and access

• Contributes, uploads, and stores the research data

• Defines federated data stores

Defines and Validates Data• Creates, manages, and searches data

elements and form structures• Validates research data against the

defined validation rules

Clinical Trial / Research• Defines electronic case report forms• Schedules and collects clinical data• Exports, analyzes and reports on

collected data

Global Unique Identifier System• Allows researchers to share data

specific to study participants• Correlates participants across studies

without exposing personally identifiable information (PII)

MIPAV Imaging Data Submission• Image submission tool• Image analysis tool• 3D Image visualization

Query, Report and Export Data• Includes locally collected research

data• Includes research data from defined,

federated sites

Meta Study (Nov 2015)• DOI reference• Analyzed data• Meta data defined by BD2K/BioCaddie• Commons compliant

Submission Dataflow

VALIDATE & SUBMIT RESEARCHER USE COLLABORATION SHARED ACCESSCAPTURE

NEUROIMAGING

GENOMICS

ASSESSMENT DATA

Data DictionaryNLM BMIC CDE WG PROMIS Neuro-QoL NIH toolbox PHENXCDISCONC/SDCREDCap

BRICS customized for specific projects

• Federal Interagency Traumatic Brain Injury (FITBIR) http://fitbir.nih.gov/ Overall award winner - Federal Health IT (FHIT)

• Center for Neuroscience and Regenerative Medicine (CNRM)

• Parkinson’s Disease Biomarker Program (PDBP) http://pdbp.ninds.nih.gov/

Overall award winner – ACT-IAC

• GUID brick deployed in support of GRDR

• CiSTAR – NINDS intramural program

PDBP Data Management Resource (DMR)

What is the PDBP DMR?The PDBP Data Management Resource (PDBP DMR) and NINDS Biorepository collaborate to support new and existing research promoting biomarker discovery for Parkinson's disease.

DNA RNA serum Plasma CSF WB0

500

1000

1500

2000

2500

3000

783

16961299 1463

233

1503375

705

431505

102

533

PDBP Biospecimen Collection by Sample Type

Control

Case

0

10000

20000

30000

40000

50000

60000

Total Records Collection for PDBP Prospective Study

Total Records

Feb 2013

Jun 2013

Jan 2014

Jun 2014

Jan 2015

Jun 2015

25919754

5

343

Demographics of PDBP SubjectsFemale Control Male CaseFemale Control Male CaseFemale Control Male CaseFemale Control Male Case

Number of Subjects

Total = 4,603 subjects as of April 15, 2015

113 24 882

6

1213

83

599

371

68

98

926176

31

13

Albert Einstein College of Medicine

Baylor College of Medicine

Emory University (ProTECT III)

Harvard Medical School

Harvard Medical School (COBRIT)

Uniformed Services University

University of California, San Francisco (TRACK-TBI Pilot)

University of Maryland, Baltimore

University of Michigan

University of Pittsburgh (ADAPT)

University of Washington (CHAI)

University of Washington

Wake Forest University

Washington University

FITBIR (funded by DOD and NINDS)

Number of Data Records by Category

30832959

7819

2574

13824

39167

87193

7115

Administrative

Biomarkers

Demographics

Eligibility Screening

Imaging Assessments

Medical Information

Outcome Assessments

Patient History

FITBIR

• Standard use of standardized forms/CDEs

• NIH standard CDEs for demographics (Age, Height, Gender (not so easy), Weight, …)

• Mapping tool that maps CDEs in library A to CDEs in library B and CDEa’s PVs to CDEb’s PVs

- GenderVala.Male = Gndrb.M = gendCDISCc.1

• Easy access to CDE libraries (PROMIS, CDISC) – NLM CDE tool is helping with the process

Lessons