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The NIH Biomedical Translational Research Information System (BTRIS) James J. Cimino, MD Chief, Laboratory for Informatics Development NIH Clinical Center Town Hall Meeting Lipsett Amphitheater Tuesday, September 16, 2008

The NIH Biomedical Translational Research Information System (BTRIS) James J. Cimino, MD Chief, Laboratory for Informatics Development NIH Clinical Center

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The NIH Biomedical Translational Research Information System

(BTRIS)James J. Cimino, MD

Chief, Laboratory for Informatics DevelopmentNIH Clinical Center

Town Hall MeetingLipsett Amphitheater

Tuesday, September 16, 2008

PatientAccrual

Data in the Research Process

RecruitmentPublications

IRBApproval

Write Protocol

HypothesisGeneration

Reporting

Data GatheringAnd Analysis

Access to Research Data at NIH• Data are in:

– CRIS– Institute/Center systems– Archives– Individual laboratory systems– Lab notebooks

• Data to be analyzed by:– Subject– Cohort

• Data needed for reporting:– Institutional Review Board– ClinicalTrials.Gov

• Reuse of data– Secondary studies– Hypothesis generation and testing– Patient recruitment

BTRIS Proof-of-Concept Demo• PIs volunteered 29 protocols• Protocols included 8000 patients• Collected all data on 8000 patients from:

– Clinical Research Information System (CRIS)– Clinical Data Repository (CDR)– Clinical Research Information Management

System of the NIAID (CRIMSON)• Data types:

– Demographics– Vital Signs– Laboratory– Radiology– Medications

BTRIS Proof-of-Concept Demo• Data “scrambled”:

– All dates shifted, relative to a random, patient-specific date

– All numeric values randomly altered

• Access open to all NIH investigators– NIH ID– Request password– Canned reports– Ad hoc queries

• Demonstration purposes only!

B RISB RIS

BTRIS in the Research Process

Recruitment

PatientAccrual

Publications

IRBApproval

Write Protocol

HypothesisGeneration

Reporting

Data GatheringAnd Analysis

BTRIS in the Research Process

B RISB RIS Recruitment

PatientAccrual

Publications

IRBApproval

Write Protocol

HypothesisGeneration

Reporting

Data GatheringAnd Analysis

BTRIS in the Research Process

B RISB RIS Recruitment

PatientAccrual

Publications

IRBApproval

Write Protocol

HypothesisGeneration

Reporting

Data GatheringAnd Analysis

BTRIS in the Research Process

B RISB RIS Recruitment

PatientAccrual

Publications

IRBApproval

Write Protocol

HypothesisGeneration

Reporting

Data GatheringAnd Analysis

BTRIS in the Research Process

B RISB RIS Recruitment

PatientAccrual

Publications

IRBApproval

Write Protocol

HypothesisGeneration

Reporting

Data GatheringAnd Analysis

BTRIS in the Research Process

B RISB RIS Recruitment

PatientAccrual

Publications

IRBApproval

Write Protocol

HypothesisGeneration

Reporting

Data GatheringAnd Analysis

Access to BTRIS

• NIH User ID

• Password request to Adam Pleasant:[email protected](301) 443-7490

• After this session in Lipsett Lobby

• btris.nih.gov

btris.nih.gov

btris.nih.gov