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

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

4. Content of Report OPEN REPORT OPEN REPORT CLOSED REPORT CLOSED REPORT

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

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

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

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

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

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

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

12. Data Quality Control DMCOC should participate in site training DMCOC should participate in site training Need a procedure to solve repeat problems with CRFs completion Need a procedure to solve repeat problems with CRFs completion Need help from Minnesota on electronic filing Need help from Minnesota on electronic filing Paper 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 Should be restricted to site Appt reminders,visit schedules Appt reminders,visit schedules Cd4+ and viral load trends Cd4+ and viral load trends Follow-up attendance and withdrawal Follow-up attendance and withdrawal Clinical events Clinical events AR history and changes AR history and changes Adherence Adherence

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

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

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

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

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

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

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