Federal Interagency Traumatic Brain Injury Research (FITBIR)

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1 Federal Interagency Traumatic Brain Injury Research (FITBIR) Matthew J. McAuliffe, PhD Co-director FITBIR Chief, Biomedical Imaging Research Services Section (BIRSS) (301)

2 Challenges 1. Research Small sample size Studies of the same subject at multiple locations Lack of detailed visibility in all available TBI research Unable to easily validate other s results 2. Data accessibility Data takes months/years to get into papers/journals Data is typically summarized and rarely complete Data acquired not using CDEs Data lost after grant ends

3 FITBIR The FITBIR is a collaborative biomedical informatics system to support research in Traumatic Brain Injury to accelerate scientific discovery and treatment FITBIR mission goals: 1. Promotion for the sharing of quality research data throughout the TBI research community a. Attribution for shared data b. Timing of sharing data c. Access model 2. Definition of standards to enable cross site meta-analysis and data comparisons (i.e. NINDS TBI CDEs, GUID) 3. Central repository and portal for phenotypic, genomic, and imaging data. 4. Deployment of useful tools for community adoption

4 Collaboration Collaboration

5 FITBIR

6 TBI CDEs & DE

7 Submission Dataflow CAPTURE VALIDATE & SUBMIT RESEARCHER USE COLLABORATION QUALIFIED ACCESS NEUROIMAGING GENOMICS ASSESSMENT DATA

8

9 2 1 PII Researcher/ Clerk Researcher System Researchers GUID are client able application 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 Researcher One-Way Hashes 4 GIUD GUID + Data Query CIT Hosting (Bldg 12) GUID GUID Server 7 Data Shared Public DB GUIDa + Data GUIDb + Data... GUID DB GUIDa + Hashes GUIDb + Hashes... Public Shared Data Repository Researcher logs into GUID client on their university PC and enters in subject PII GUID GUID client server (on returns university a GUID identifier. computer) If uses the one personnaly way hashes match identifiable a known Once information subject, data an is in the to One way hashes derive existing dataabase, a series GUID a of are will researcher sent off to the one be way returned. may hashes GUID query server for which If this this securely is a data. new The subject, reference GUID and encrypt a allows PII new researchers GUID storage. No information will be to distinguish personally returned. between identifiable unique information subjects Once the and is sent researcher recurrent to the system has a subjects GUID, s/he across may all submit datasets. data associated with this subject. No data may be submitted to the system without a GUID.

10 GUID Client

11 Validation Tool

12 Studies and Meta-Studies STUDY META - STUDIES Researcher 1 Researcher 2 Researcher 3 Can Contain: Study Methods Publications Link to Websites Link to Clinical Trials.gov Analyzed Images Tools Used Can Contain Information About a Collection Such as: Title Date Interventions Etc.

13 Export Results

14 FITBIR Timeline ( ) 2012) November 2011 Initial UAT testing Global Unique ID (GUID) Server up running Web Dictionary Tool V1.0 with NINDS TBI CDEs Validation Tool V1.0 Website June 2012 FITBIR Version 1.0 submission ready Dictionary Tool with CDEs Validation Tool Accounts/Portal Study Definition Repository Manager Limited function Query Tool Beta Forms Generation tool (collaborating with CNRM Yang Fann)

15 Summary 1. Cross database analysis -CDEs - GUID - Node on a grid 2. Hybrid (data warehouse, federation) Governance Policy User Requirements 3. Controlled access Implementation 4. Access to high quality data - validate study results - test new hypothesis via meta study 5. Tools to support data acquisition Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age; National Academy of Sciences ISBN: , 188 pages, (2009) EXS.pdf (Executive Summary)

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