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

Patient Accrual Data in the Research Process Recruitment Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And 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 RIS BTRIS in the Research Process Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

BTRIS in the Research Process B RIS Recruitment Patient Accrual Publications IRB Approval Write Protocol Hypothesis Generation Reporting Data Gathering And Analysis

Access to BTRIS NIH User ID Password request to Adam Pleasant: (301) After this session in Lipsett Lobby btris.nih.gov