Data and IT Working GroupData and IT Working Group

J Mthethwa, J Neaton, M Serfontein, H Potgieter, P Khabo, M J Mthethwa, J Neaton, M Serfontein, H Potgieter, P Khabo, M Gezmu, D Follmann V Jezile, P Ntshangase, CooperGezmu, D Follmann V Jezile, P Ntshangase, Cooper

OutlineOutline

Specific issuesSpecific issues• DSMBDSMB• Data requestsData requests• Web-based reportsWeb-based reports• Data quality controlData quality control• Telecommunications and NLM accessTelecommunications and NLM access

Accomplishments and GoalsAccomplishments and Goals Resource needsResource needs Group compositionGroup composition Changes to post-descriptionsChanges to post-descriptions

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

Content of ReportContent of Report

OPEN REPORTOPEN REPORT

CLOSED REPORTCLOSED REPORT

Open ReportOpen Report

Enrolment: Enrolment: baseline characteristics (Nothing is shown baseline characteristics (Nothing is shown

by treatment group). Pooled data onlyby treatment group). Pooled data only Eligibility violationsEligibility 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.

Closed ReportClosed Report Baseline characteristics by treatment groupBaseline characteristics by treatment group - 4 groups and- 4 groups and -main effects-main effects EFV vs n/LPVEFV vs n/LPV d4T + 3TC vs AZT + ddTd4T + 3TC vs AZT + ddT Completeness of follow- upCompleteness of follow- up Treatment discontinuations and changes in Treatment discontinuations and changes in

randomized treatment.randomized treatment. AdherenceAdherence Viral load and cd4+Viral load and cd4+ AIDS /Death : all deaths AIDS /Death : all deaths Adverse events. Adverse events.

Timeline for DSMB ReportTimeline for DSMB Report

AUGUSTAUGUST -Prepare mock-up report-Prepare mock-up report -Protocol team and EC review report-Protocol team and EC review report SEPTEMBERSEPTEMBER - Write programs- Write programs OCTOBEROCTOBER -Write programs-Write programs -Generate 1-Generate 1st st by unblinded Statistician by unblinded Statistician NOVEMBERNOVEMBER - Generate final report- Generate final report - DSMB MEETING- DSMB MEETING

Data RequestsData Requests

Phidisa I and II are probably different Phidisa I and II are probably different in terms of data accessin terms of data access

Phidisa I Information is OPEN dataPhidisa I Information is OPEN data Phidisa II Information is CLOSED dataPhidisa II Information is CLOSED data Standard reports will be posted on Standard reports will be posted on

the internal web sitethe internal web site Other reports will go through formal Other reports will go through formal

mechanism.mechanism.

Data RequestData RequestConsiderations for ReviewConsiderations for Review

Agreement between SANDF and the NIHAgreement between SANDF and the NIH Summary data only; no raw dataSummary data only; no raw data Who can request? An SOP for data requests is Who can request? An SOP for data requests is

needed.needed. Format of request – should be standardFormat 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 work load schedule and priorities for

DMCOC staffDMCOC staff Point person: Paul Khabo Point person: Paul Khabo

SOP for DMCOC Data Analysis SOP for DMCOC Data Analysis Request ReviewRequest Review

Paul (Biostatistics)Paul (Biostatistics) Protocol chairProtocol chair DMCOC Director or others as DMCOC Director or others as

requiredrequired Abstracts, Presentations and papers Abstracts, Presentations and papers

should be reviewed by the EC as well should be reviewed by the EC as well as the DMCOC as the DMCOC

Web-based ReportsWeb-based Reports

Query working groupsQuery working groups Standard set updated regularly (daily , Standard set updated regularly (daily ,

weekly)weekly) Timeline – OctTimeline – Oct Need other items on the web in addition to Need other items on the web in addition to

data summaries – CRFs, protocol, manual data summaries – CRFs, protocol, manual minutes of meetings/calls, staff directoryminutes of meetings/calls, staff directory

Summary reportsSummary reports - Enrolment, baseline characteristics, - Enrolment, baseline characteristics,

follow-up visits attendancesfollow-up visits attendances

Data Quality ControlData Quality Control

DMCOC should participate in site DMCOC should participate in site trainingtraining

Need a procedure to solve repeat Need a procedure to solve repeat problems with CRFs completionproblems with CRFs completion

Need help from Minnesota on Need help from Minnesota on electronic filingelectronic filing

Paper filingPaper filing

Data Quality Control Data Quality Control cont.cont.

Need more training for Data entry Need more training for Data entry clerksclerks

A point person needs to be identified A point person needs to be identified for MOOP changes, form changesfor MOOP changes, form changes

A version control system should be A version control system should be established established

Patient Specific ReportPatient Specific Report

Should be restricted to siteShould be restricted to site Appt reminders ,visit schedulesAppt reminders ,visit schedules Cd4+ and viral load trends Cd4+ and viral load trends Follow-up attendance and withdrawalFollow-up attendance and withdrawal Clinical eventsClinical events AR history and changesAR history and changes AdherenceAdherence

TelecommunicationTelecommunication

In processIn process• Better communication at current sites Better communication at current sites

and DMCOC and DMCOC Mtubatuba & 1 Mil > mid SeptemberMtubatuba & 1 Mil > mid September

• Web site > working progress – mid Web site > working progress – mid AugustAugust

National Library of MedicineNational Library of Medicine

Access to journalsAccess to journals Will be made available to DMCOCWill be made available to DMCOC Who is it for?Who is it for? Timeline - AugustTimeline - August

AccomplishmentsAccomplishments

Establishment of DMCOCEstablishment of DMCOC Staff, equipment ,system installation, Staff, equipment ,system installation,

training ,communications, MOOP, training ,communications, MOOP, forms.forms.

Initiation of protocols and collection Initiation of protocols and collection of dataof data

SAS for statistics (reporting SAS for statistics (reporting capabilities) capabilities)

Goals: Upcoming yearGoals: Upcoming year

Improve data flow at DMCOCImprove data flow at DMCOC Training to improve data collectionTraining to improve data collection Expand reporting capabilitiesExpand reporting capabilities DSMB reportDSMB report

Goals: Upcoming year Goals: Upcoming year cont.cont.

Additional statistical trainingAdditional statistical training Training in system management and Training in system management and

develop and in data managementdevelop and in data management Implement new protocolImplement new protocol - CRFs, Data entry screens, - CRFs, Data entry screens,

randomization and reports.randomization and reports. Web- based reportsWeb- based reports Ongoing review of PDs and personnel Ongoing review of PDs and personnel

availabilityavailability

Resource NeedsResource Needs

Data managementData management no. of FTEs TBD based on review of PDs no. of FTEs TBD based on review of PDs StatisticsStatistics 1.5 FTE1.5 FTE ITIT 0.5 FTE0.5 FTE Before Phidisa 3 is implemented Before Phidisa 3 is implemented

review DMCOC operations after review DMCOC operations after additional new sitesadditional new sites

Working Group CompositionWorking Group Composition

Estelle Vivier – Health InformaticsEstelle Vivier – Health Informatics

Protocol groupsProtocol groups

Meeting with all DMCOC staff prior to Meeting with all DMCOC staff prior to annual meetingannual meeting