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