matthew j. mcauliffe, ph.d., chief, biomedical imaging research services section (birss) cit

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Matthew J. McAuliffe, Ph.D., Chief, Biomedical Imaging Research Services Section (BIRSS) CIT

Ramona Hicks, Ph.D., Program Director, Repair and Plasticity NIH/NINDS

Douglas Gibson, Ph.D., Deputy Neurotrauma Research Coordinator USAMRMC-CCCRP (RAD2)

Federal Interagency Traumatic Brain Injury Research (FITBIR)

Informatics System

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Why do we bring all this data together?

to replicate experiments

to ask new questions

to simulate

to model

to share

to publish

to teach

to search

to analyze

to visualize

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The FITBIR framework is a collaborative biomedical informatics system to support research at NIH to accelerate scientific discovery and treatment. The mission of BRICS is accomplished by the:

1. Definition of standards to enable cross site meta-analysis and data comparisons (e.g. NINDS CDEs)

2. Deployment of useful tools for community adoption 3. Promotion for the sharing of quality research data

throughout the research community 4. Central Repository and Portal to phenotypic, genomic,

imaging and pedigree data.

FITBIR

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BRICS Components

Clinical Trial / Research• Defining electronic case

report forms• Scheduling and collecting

clinical data• Exporting, analyzing and

reporting on collected data.

Study Management and Data Submission• Defining and managing

study information and access

• Contributing, uploading, and storing the research data

• Define federated data stores

Querying, Reporting and Exporting Data• Include locally collected

research data• Include research data

from defined, federated sites.

Defining and Validating Data• Creating, managing, and

searching data elements and form structures

• Validating research data against the defined validation rules

Global Unique Identifier System• Allows researchers to share data

specific to study participants• Correlate participants across

studies without exposing personally identifiable information (PII)

User Account Management• Creating, approving, and

managing user accounts• Managing access controls,

roles & permissions• Single sign on

MIPAV Imaging Tool• Image submission tool• Image analysis tools• 3D Image visualization

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Generic

Forms Tool

(eCRF)

ProFoRM

(eCRF+)

RESTFUL API

GUIDRepository

ManagerData Access

GUID Webstart

Client

Data Dictionary

NINDS CDEs,

Unique DE

Validation Webstart Tool

Upload Tool Download MgrQuery Tool

Meta

DataRaw Data

Export

Package

Query

Results

Data Submission Data Access

FITBIR Arch

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Generic

Forms Tool

(eCRF)

ProFoRM

(eCRF+)

RESTFUL API

GUIDRepository

ManagerData Access

GUID Webstart

Client

Data Dictionary

NINDS CDEs,

Unique DE

Validation Webstart Tool

Upload Tool Download MgrQuery Tool

Meta

DataRaw Data

Export

Package

Query

Results

Data Submission Data Access

FITBIR Arch

Data Analytics

(Big Data)

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Submission Dataflow

• VALIDATE & SUBMIT • RESEARCHER USE • COLLABORATION • QUALIFIED ACCESS• CAPTURE

• NEUROIMAGING

• GENOMICS

• ASSESSMENT DATA

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Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1

• Researcher logs into GUID client on their university PC and enters in subject PII


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1

• GUID client (on university computer) uses personnaly identifiable information to derive a series of one way hashes which securely encrypt PII information


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1

• One way hashes are sent off to the GUID server for reference and storage. No personally identifiable information is sent to the system


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data


...

2

1

• GUID server returns a GUID identifier. If the one way hashes match a known subject, an existing GUID will be returned. If this is a new subject, a new GUID will be returned.


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data


...

2

1

• Once the researcher has a GUID, s/he may submit data associated with this subject. No data may be submitted to the system without a GUID.


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data


...

2

1


Researcher/ Clerk

PII3

4

5


GUID Server

GUID



...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data


...

2

1

• Researchers are able to access data across studies, without revealing personally identifiable information, while correlating study data across different studies AND uniquely sorting between distinct and redundant datasets

Shared

Shared Data

Repository

GUID

• Once data is in the database, a researcher may query this data. The GUID allows researchers to distinguish between unique subjects and recurrent subjects across all datasets.

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Validation Tool

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ProFoRMS

Build Form Page

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Image Analysis Tool http://mipav.cit.nih.gov

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Future work

1. Define pipeline APIs for imaging, meta-data, genomics• Cloud• API to support multiple processing applications

2. Further development of imaging CDEs to support the description of DTI and related images stored in the database

matthew j. mcauliffe, ph.d., chief, biomedical imaging research services section (birss) cit

Documents

data comparisons

data specific

data submissiondefining

data elements

pedigree data

guid identifier

pii information

study information