1. Data and IT Working Group J Mthethwa, J Neaton, M Serfontein, H Potgieter, P Khabo, M Gezmu, D Follmann V Jezile, P Ntshangase, Cooper

2. Outline • Specific issues • DSMB • Data requests • Web-based reports • Data quality control • Telecommunications and NLM access • Accomplishments and Goals • Resource needs • Group composition • Changes to post-descriptions

3. DSMB A meeting in November Who is on DSMB? Should be independent. Unblinded statistician: Mr. P. Khabo (and Mr. G Grandits) Access to closed report: DSMB and unblinded statistician only. Access to open report : all Phidisa staff Regular meetings every 6 months: Tele conferences may be possible after 1st face-to-face meeting.

4. Content of Report • OPEN REPORT • CLOSED REPORT

5. Open Report • Enrolment: baseline characteristics (Nothing is shown by treatment group). Pooled data only • Eligibility violations • Follow-up • Treatment discontinuation or changes. • Overall cd4+ and viral load response. • Overall clinical endpoint rate. • List of serious Adverse events and death.

6. Closed Report • Baseline characteristics by treatment group - 4 groups and -main effects EFV vs n/LPV d4T + 3TC vs AZT + ddT • Completeness of follow- up • Treatment discontinuations and changes in randomized treatment. • Adherence • Viral load and cd4+ • AIDS /Death : all deaths • Adverse events.

7. Timeline for DSMB Report • AUGUST -Prepare mock-up report -Protocol team and EC review report • SEPTEMBER - Write programs • OCTOBER -Write programs -Generate 1st by unblinded Statistician • NOVEMBER - Generate final report - DSMB MEETING

8. Data Requests • Phidisa I and II are probably different in terms of data access • Phidisa I Information is OPEN data • Phidisa II Information is CLOSED data • Standard reports will be posted on the internal web site • Other reports will go through formal mechanism.

9. Data RequestConsiderations for Review • Agreement between SANDF and the NIH • Summary data only; no raw data • Who can request? An SOP for data requests is needed. • Format of request – should be standard • Requests will be considered based on: • scientific merit • possible interference with study • purpose and extent of dissemination. • work load schedule and priorities for DMCOC staff • Point person: Paul Khabo

10. SOP for DMCOC Data Analysis Request Review • Paul (Biostatistics) • Protocol chair • DMCOC Director or others as required • Abstracts, Presentations and papers should be reviewed by the EC as well as the DMCOC

11. Web-based Reports • Query working groups • Standard set updated regularly (daily , weekly) • Timeline – Oct • Need other items on the web in addition to data summaries – CRFs, protocol, manual minutes of meetings/calls, staff directory • Summary reports - Enrolment, baseline characteristics, follow-up visits attendances

12. Data Quality Control • DMCOC should participate in site training • Need a procedure to solve repeat problems with CRFs completion • Need help from Minnesota on electronic filing • Paper filing

13. Data Quality Control cont. • Need more training for Data entry clerks • A point person needs to be identified for MOOP changes, form changes • A version control system should be established

14. Patient Specific Report • Should be restricted to site • Appt reminders ,visit schedules • Cd4+ and viral load trends • Follow-up attendance and withdrawal • Clinical events • AR history and changes • Adherence

15. Telecommunication • In process • Better communication at current sites and DMCOC • Mtubatuba & 1 Mil > mid September • Web site > working progress – mid August

16. National Library of Medicine • Access to journals • Will be made available to DMCOC • Who is it for? • Timeline - August

17. Accomplishments • Establishment of DMCOC • Staff, equipment ,system installation, training ,communications, MOOP, forms. • Initiation of protocols and collection of data • SAS for statistics (reporting capabilities)

18. Goals: Upcoming year • Improve data flow at DMCOC • Training to improve data collection • Expand reporting capabilities • DSMB report

19. Goals: Upcoming year cont. • Additional statistical training • Training in system management and develop and in data management • Implement new protocol - CRFs, Data entry screens, randomization and reports. • Web- based reports • Ongoing review of PDs and personnel availability

20. Resource Needs • Data management no. of FTEs TBD based on review of PDs • Statistics 1.5 FTE • IT 0.5 FTE • Before Phidisa 3 is implemented review DMCOC operations after additional new sites

21. Working Group Composition • Estelle Vivier – Health Informatics • Protocol groups • Meeting with all DMCOC staff prior to annual meeting