thibela tb data management. goldfields anglo harmony tsims inform intervention baseline find tcas...
TRANSCRIPT
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