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MTN 003 MTN 003 Data Management Data Management

ConsiderationsConsiderations

SSP Sections 14, 15 & 17

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Presentation TopicsPresentation Topics• Contents of SSP section 14• CRF/label/template supplies• Site data management procedures

and considerations (SOPs)• Data Communiqués (SSP section 15)• Overview of reports produced by

SCHARP (SSP section 17)

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SSP Section 14 - ContentsSSP Section 14 - Contents• The Data Management section of the 003 SSP

contains information on:– The SCHARP MTN 003 team– DataFax overview, including entry/quality control

procedures at SCHARP (14.1)– Form completion requirements (14.2)– 003-specific data collection information, including

PTIDs, study visit timing, visit windows, visit codes, CRF completion schedule, site review of CRFs, faxing CRFs (14.3)

– Form and label supply; form storage (14.4)– Completion of interviewer-administered forms (14.5)– Additional form completion instructions (14.6)– Each MTN 003 case report form (14.7)

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SSP Section 14 – Contents, SSP Section 14 – Contents, cont.cont.

• Much of the content of Section 14 is covered in several presentations– Information on SSP Sections 14.1 – 14.2

and 14.3.6-14.3.8 is provided in the “DataFax Overview and CRF Completion” presentation

– Information on SSP Section 14.3 can be found in the “Follow-Up Visit Scheduling and Visit Coding” presentation

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MTN 003 CRF SuppliesMTN 003 CRF Supplies• SCHARP will provide all CRFs needed

for the study• CRFs provided via printed form packets• Bulk “as needed” CRFs are also

provided• Site can order more forms using the

CRF Request Form

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MTN 003 CRF Supplies, MTN 003 CRF Supplies, cont.cont.

• Form packets used in MTN 003:– Screening Part 1 – Screening Part 2– Enrollment– Monthly– Quarterly

• Also used for Semi-Annual and Annual visits; sites have to add CRFs to the packet for those two visits

– Product Use End Visit (PUEV)– Termination/Study Exit

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MTN 003 CRF Supplies, MTN 003 CRF Supplies, cont.cont.

• Form packets will only include non-translated forms– Ex. Baseline Behavior Assessment is not

included in the Enrollment visit packet

• Sites will have to add the appropriate local-language forms to each packet so that all forms needed for the visit are present – this is noted on the visit packet coversheet

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MTN 003 CRF Supplies, MTN 003 CRF Supplies, cont.cont.

•This is the Enrollment visit packet cover page

•Site will need to add appropriate local-language versions of the BBA and Screening Part 2/Enrollment Medical Eligibility forms before the participant’s visit

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MTN 003 CRF Supplies, MTN 003 CRF Supplies, cont.cont.

•For Semi-annual visits, grab a Quarterly packet, and add these forms

•For Annual visits, grab a Quarterly packet and add these forms

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MTN 003 CRF Request FormMTN 003 CRF Request Form•Complete when more MTN 003 CRFs or blank labels are needed•This is a 3-page DataFax form•Always fax all 3 pages when ordering more forms/labels•MTN 003B has it’s own CRF Request Form (1 page)

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MTN 003 Other SuppliesMTN 003 Other Supplies• SCHARP does not provide binders• SCHARP will provide templates that can be

used to create 003 binder cover and spine label inserts – SCHARP can provide a template for tab dividers

if requested• SCHARP will provide Word templates

(macros) that can be used to make specimen labels needed for 003

• SCHARP will provide bulk blank labels (small and large)

• Extra CRFs and blank labels can be ordered using the CRF Request Form

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How well do you know your 003 Data How well do you know your 003 Data Management SOP?Management SOP?

• Your 003 Data Management SOP should explain how you will perform data collection and data management procedures for 003

• Who is responsible for training site staff on the 003 DM SOP?

• Who has day-to-day oversight of staff involved in 003 data procedures?

• Who has ultimate responsibility for the quality of your site’s 003 study data?

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Data Management SOP, Data Management SOP, cont.cont.

• What will be contained in participant study files? How will they be organized? Where will they be stored- used and unused?

• Who is responsible for assembling participant study files?

• Who is responsible for assigning 003 PTIDs? How will PTIDs be assigned?

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Data Management SOP, Data Management SOP, cont.cont.

• By whom and when will CRFs be reviewed prior to faxing?

• Who is responsible for faxing and replacing CRFs in notebooks?

• Who is responsible for responding to QC Reports/Clinical QC Reports?

• All of this information and more is in your MTN 003 Data Management SOP.

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Data CommuniquésData Communiqués • Data Communiqués are memos

issued by SCHARP. • They provide information/instructions

to the sites on data collection issues that arise after study start.

• Data Communiqués are official study communication, and should be reviewed with site staff.

• Communiqués should be printed and placed in SSP section 15

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Data Communiqués, Data Communiqués, cont.cont.

• First Data Communiqué for VOICE was issued on 09-SEP-09

• Can be downloaded from MTN website

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SCHARP Study ReportsSCHARP Study Reports• The Study Reporting Plan section of

the SSP (section 17) describes all of the study reports produced by SCHARP

• This section also contains information on how reports are distributed (via email attachment or Atlas webpage)

• Discuss Data QC Reports, Clinical QC Reports, Site Data Management Quality Reports in this presentation

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Data Quality Control (QC) ReportsData Quality Control (QC) Reports• SCHARP staff review data, identify

problems such as missing or inconsistent data, and apply Quality Control (QC) notes as necessary

• QC notes are compiled into QC Reports• QC Reports may also show missing

pages and overdue visits• QC Reports are sent to sites on a

regular basis via e-mail (pdf attachment)

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Anatomy of a DataFax QC Anatomy of a DataFax QC ReportReport

Site Number and Date of QC Report

Name and contact information of

Data Coordinator

Number of pages of QC Report

Cover Letter

Study Identifier

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Anatomy of a DataFax QC Report, Anatomy of a DataFax QC Report, cont.cont.

Study Identifier

Listing of QC notes

Site Number and Date of QC Report

Number of pages of QC Report

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Anatomy of a DataFax QC Report, Anatomy of a DataFax QC Report, cont.cont.

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Clinical QC ReportsClinical QC Reports• Are very similar to QC Reports, but are

distributed by SCHARP Clinical Affairs Safety Associates (CASAs) and involve safety-related data (AEs, lab values, etc.)

• Sent via email (pdf attachment)• Are resolved by making additions or

corrections on CRF to the data in question• Clinical queries are not included in your

site’s QC rate• Molly Swenson (mollys@scharp.org) is the

CASA for VOICE

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Resolving QC issuesResolving QC issues• Sites correct or clarify QCs and refax the

corrected CRFs to SCHARP DataFax within the time period specified for the study– Timely response to QC reports is essential for

data quality

• SCHARP staff review the corrections and resolve QC notes

• QC note(s) will continue to appear if corrected CRF is not received or processed before next report is generated

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Common QC Errors to AvoidCommon QC Errors to Avoid• Illegible handwriting• Missing initials/date for corrections• Missing data• Skip patterns not followed• Wrong visit code assigned

Look for these during site CRF QA/QC review prior to faxing CRFs to SCHARP

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Data Management Quality ReportsData Management Quality Reports• Main tool used to evaluate site’s performance

regarding data management• Includes 5 parameters:

– Total number of pages faxed– Total number of QCs applied– Percentage of QCs resolved– QC rate/100 pages– Mean days to fax in

• Includes data for previous month and cumulatively

• Data from all sites included

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Data Management Quality Reports, Data Management Quality Reports, cont.cont.• Reports are used to identify data

management issues/patterns• Please contact Karen and Laura with

any questions about this report (we may be contacting you as well, depending on the situation)

• Reports are produced monthly • Will be available via the Atlas

webpage

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Accessing MTN 003 Reports via AtlasAccessing MTN 003 Reports via Atlas• Atlas is a secure web page maintained

by SCHARP• It is used to post documents and data

for various networks/projects SCHARP is involved with (HVTN, MTN, HPTN, CHAVI, etc.)

• To access Atlas, type http://atlas.scharp.org

• Click on MTN logo• Click on MTN 003

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MTN 003 Reports on AtlasMTN 003 Reports on Atlas

• Click on MTN 003 • Under “MTN 003 Open Reports” section, you will see the

Site Data Management Quality Report

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MTN 003 Reports on Atlas,MTN 003 Reports on Atlas, cont. cont.

• Some 003 reports will be in the open section, some will be in the secure section (e.g. PSRT Reports)

• A login and password is required for secure study reports, and access is maintained by SCHARP

• SSP Section 17 details which reports are open and which are secure

• Questions about Atlas? Email atlas@scharp.org

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Questions???Questions???