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Thibela TB Data Management
Goldfields
Anglo
Harmony
TSIMS
INFORM
Intervention
Baseline
FIND
TCAS
INH Adherence
Intervention
Baseline
FIND
TCAS
Data Sources
Chest X-rays
INTERVENTION SITES
Control Sites
Central Server
Inform Site ServerStudy Centre
PhaseforwardSupport
BTG Support
3G
TSIMS Site Server
Site Support
OrkneyCVL CVL Orkney Welkom
Analyst
Welkom TCAS & FIND
Thibela DM Processes
Data Monitoring
IT & Software
Programmer
•SDV
•Site Set-up & Maintenance
•Support
•CXR & TSIMS Recon
•TSIMS & Inform Recon
•TCAS & FIND Data Entry
•SAE Recon
•CXR Retrieval
•Reports
•Queries
•Adverse Events
•Missed Visits
•Protocol Deviations
•Freezing & Locking
•Withdrawals
•Collection
•SDV
•Queries
•Reports
•Freezing & Locking
•Filing
•Tracking
•HR Data
•Report & Query Dev.
•Database Development
•Support
•DB Monitoring
•Site Set-up
•User Management
Training & Quality Control
•Inform
•TSIMS
•CRF’s
•Query Rates
•Data QC
•Site QC
•DM SOP’s & Guidelines•INH Resistance Study•INH Adherence Study
Data Volume In-house (14 Sept ’07)
Main Baseline TCAS FIND
Tau Tona 3555 2538 1422 1548Great Noligwa 4176 1683Elandsrand 2157 1976Beatrix 4 1503 1139Moab Khotsong 307 463
11698 7799 1422 1548
Site Name Auto Manual
Tau Tona 11,051 2,425
Beatrix 4 2,530 370
Elandsrand 3,600 259
Great Noligwa 11,458 1,986
Summary 28,639 5,053
Data Queries
Challenges
• Operational Reports
• Data Monitoring
• TDE’s
• Research Topics
• HR Data