MTN 003 Data Management Considerations

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MTN 003 Data Management Considerations

• SSP Sections
• 14, 15 17

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Presentation 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 - 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, 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 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, 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, 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, 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 participants visit

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MTN 003 CRF Supplies, 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 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 its own CRF Request Form (1 page)

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MTN 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 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 sites 003 study data?

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Data Management SOP, 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, 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 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, cont.

• First Data Communiqué for VOICE was issued on
  09-SEP-09
• Can be downloaded from MTN website

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SCHARP 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) 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 Report
Study Identifier
Site Number and Date of QC Report
Cover Letter
Name and contact information of Data Coordinator
Number of pages of QC Report
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Anatomy of a DataFax QC Report, cont.
Study Identifier
Site Number and Date of QC Report
Listing of QC notes
Number of pages of QC Report
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Anatomy of a DataFax QC Report, cont.
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Clinical 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 sites
  QC rate
• Molly Swenson (mollys_at_scharp.org) is the CASA for
  VOICE

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Resolving 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 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 Reports

• Main tool used to evaluate sites 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, 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 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 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, 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_at_scharp.org

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Questions???