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Thibela TB Data Management

Thibela TB Data Management. Data Sources. Intervention. TSIMS. Goldfields. Baseline. FIND. Anglo. TCAS. Harmony. INH Adherence. Chest X-rays. INFORM. Intervention. Baseline. FIND. TCAS. INTERVENTION SITES. Phaseforward Support. Inform Site Server. Study Centre. Control Sites.

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Thibela TB Data Management

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  1. Thibela TB Data Management

  2. Data Sources Intervention TSIMS Goldfields Baseline FIND Anglo TCAS Harmony INH Adherence Chest X-rays INFORM Intervention Baseline FIND TCAS

  3. INTERVENTION SITES

  4. Phaseforward Support Inform Site Server Study Centre Control Sites 3G Central Server TSIMS Site Server BTG Support

  5. Thibela DM Processes • DM SOP’s & Guidelines • INH Resistance Study • INH Adherence Study Training & Quality Control • Inform • TSIMS • CRF’s • Query Rates • Data QC • Site QC IT & Software Data Monitoring Site Support Programmer Analyst • HR Data • Report & Query Dev. • Database Development • Support • DB Monitoring • Site Set-up • User Management CVL Orkney Welkom CVL Orkney Welkom TCAS & FIND • Collection • SDV • Queries • Reports • Freezing & Locking • Filing • Tracking • 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

  6. Data Volume In-house (14 Sept ’07)

  7. Data Queries

  8. Challenges • Operational Reports • Data Monitoring • TDE’s • Research Topics • HR Data

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