Established in 2003, PHRU’s Statistics and Data Management Centre (SDMC) manages PHRU’s investigator-initiated and network-sponsored studies, including those conducted by the:

  • HIV Prevention Trials Network (HPTN)
  • HIV Vaccine Trials Network (HVTN)
  • Microbicide Trials Network (MTN)
  • International AIDS Vaccine Initiative (IAVI)
  • AIDS Clinical Trials Group (ACTG)
  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT)
  • Comprehensive International Program of Research on AIDS, South Africa (CIPRA-SA)

Using DataFax®, an innovative system based on intelligent character
recognition, the highly trained SDMC team:

  • provides data management services for IAVI’s epidemiological studies conducted in Africa and the CIPRA study in Senegal;
  • supports research sites in South Africa, Zimbabwe, Uganda, Kenya, Rwanda, Zambia and Senegal;
  • generates interim safety reports for data and safety monitoring board reviews; and
  • drafts statistical sections of research protocols, statistical analysis plans and primary, secondary and other analyses.

Operations at the SDMC are governed by a comprehensive set of standard operating procedures and the SDMC subscribes to the guidelines on Good Clinical Data Management Practices as published by the Society for Clinical Data Management.

Contract with the Statistical Data Management Centre

If you are interested in contracting the Statistical Data Management Centre (SDMC) for the provision of your data management services, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

The SDMC offers the following skills and capabilities:

  • Regulatory document preparation and submission
  • Data capture (DataFax, MS Access, eData)
  • Database development (DataFax, MS Access)
  • SOP development
  • CRF development
  • Compiling participant study binders
  • DataFax study setup:
    • Variable definition
    • Edit Check development
    • Visit Schedule programming
    • Setup testing/validation
  • Generation and distribution of study QC reports
  • Data cleaning
  • Programming and creation of Monitoring/Status reports (SAS/MS Excel)
  • Development of Statistical Analysis Plans (SAPs)
  • Development of SAP table shells (templates)
  • Clinical coding (MedDRA, ACTG Appendix 3)
  • Quality assurance
  • Randomisation tools
  • Website hosting for QC/Status reports
  • Training