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

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