Data Standards & Integration Workgroup Q3-2015 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. A key focus is aggregating all relevant data in a secure database for analysis by the CPTR Workgroups and authorized researchers.
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.
- Provide the infrastructure/architecture of the Information Technology and Data Management systems for the CPTR Consortium.
- Develop Clinical Data Interchange Standards Consortium (CDISC-TB) data standards.
- Convert all data domains and individual data elements requested by the other Regulatory Science Consortium Workgroups to a standard usable format for population of the integrated database.
Data Standard Tuberculosis v2:
- Data Contribution Agreements are pending final signature by St. George University/Rifaquin, WHO/OFLOTUB and TB Alliance/REMox. The WHO/C-Path TB Clinical Trials Data Sharing Platform governance process was approved by WHO and TB Alliance.
- The Data Standards and Integration Workgroup (DSI-WG) and C-Path CPTR Data Team are on track to deliver the TB Data Standard v2.0 in the first quarter of 2016. The first draft of the data standard document, including CDISC study data tabulation model (SDTM) tables and clinical text describing each concept is complete, and has completed a required CDISC internal review process. The project is on track to meet the next deliverable of a public comment period starting in November, 2015.
Data re-mapping to the TB Standard v1:
- Total number of trials currently identified: 23
- Number of trials with data in-house: 14
- Number of trials with remapping complete: 14
- Number of trials pending data transfer, but agreed to share: 9
- The Gatifloxacin data set was remapped to CPTR CDISC TB Data Standard v1.0.