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