Anita Walden Duke Translational Medicine Institute Tuberculosis Data Standardization and Harmonization Supported by BAA-RM-04-23 “Assessing Critical Research Needs in TB Diagnostics in HIV- Infected and Uninfected Children” Kirkland Center, National Labor College Silver Spring, MD June 30, 2011
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Anita WaldenDuke Translational Medicine
Institute
TuberculosisData Standardization and
Harmonization
Supported by BAA-RM-04-23
“Assessing Critical Research Needs in TB Diagnostics in HIV-
Infected and Uninfected Children”
Kirkland Center, National Labor CollegeSilver Spring, MD
Project StepsCreated stakeholder groupCreated master data element list from healthcare and related secondary usesDefine a set of data elements according to the ISO 11179 standard (TB139 data elements)Developed consensus clinical definitions for the data elementsCreated a dynamic model of the domain represented through an activitydiagram, using the UML standardCreated a research representation of the data elements in the CDISC SDTM model.Made the resulting standards available to the public through an ANSI accredited balloting processStorage in NCI Meta-data Repository
101 Did the Subject Complete Treatment for Tuberculosis?
Subject received all anti-Tuberculosis medication, as prescribed
No; Yes; NA; Unknown
102 Tuberculosis Treatment Failure Reason
Specified reason assigned to explain microbiological or clinical failure of Tuberculosis drug therapy to have resulted in culture-conversion to negative with 16 weeks of Tuberculosis drug initiation, or clinical improvement within the same time frame.
Primary Drug resistance; Secondary Drug resistance; Inadequate serum drug levels; Non-compliance; Extensive disease; unknown; Other (specify)
103 Reason for Study Tuberculosis Treatment Discontinuation
A statement offered in explanation or justification for permanent discontinuation of one or more Tuberculosis drugs being given in the context of a research study
Refused study therapy; Pregnant; Death; Withdrew consent; Physician stopped study Rx/MD Decision; Lost to follow up; Adverse effect; Subject moved; Incarceration; False-positive culture