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Data Standards & Integration Workgroup (DSI-WG) Q4-2015 Update

The DSI-WG provides the information technology (IT) infrastructure to support all CPTR data needs for developing regulatory science tools and methods to enable development of new TB drugs, drug regimens, and diagnostics. Aggregating all relevant data in a secure database for analysis by the CPTR Workgroups and authorized researchers is a key focus for this group.

The DSI-WG addresses the requirements of gathering, assessing, standardizing, and pooling disparate sources of clinical and laboratory data into an integrated secure database. The DSI-WG describes the work needed to develop standards for remapping and integrating data from a variety of sources and formats. It also addresses how the Consortium will integrate, submit, store, access, and analyze the data in the centralized system.

Objectives:                                            

4Q, 2015 Progress:

Data Standard Tuberculosis v2:

Data re-mapping to the TB Standard v1 and v2:

Appendix:

The list of TB clinical trial data-sets in-house that have been remapped to CPTR CDISC-TB Data Standard v.1.0.:

wgupdates

TB Clinical Trial Data Sets In-House (17)

The list of TB clinical trial data-sets in-house that have been remapped to CPTR CDISC-TB Data Standard v.2.0.:

Study Name Contributors Drugs Number of Subjects
Rifaquin St. Georges University of London Rifapentine, Moxifloxacin 1250
REMoxTB Global Alliance for TB Drug Development Moxifloxacin, + Ethambutol, Isoniazid, Pyrazinamide & Rifampicin 1931
Oflotub World Health Organization, European Commission, Institut de Recherche pour le Developpement Gatifloxacin combined regimen 1836

 

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