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MTN 003 Data Management Considerations


Title: Quality Control Reports Author: scharp user Last modified by: lmckinst Created Date: 4/20/2004 10:22:22 PM Document presentation format: On-screen Show – PowerPoint PPT presentation

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Title: MTN 003 Data Management Considerations

MTN 003 Data Management Considerations
  • SSP Sections
  • 14, 15 17

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)

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
  • Additional form completion instructions (14.6)
  • Each MTN 003 case report form (14.7)

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

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

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

MTN 003 CRF Supplies, cont.
  • Form packets will only include non-translated
  • 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

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

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

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
  • MTN 003B has its own CRF Request Form (1 page)

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
  • SCHARP will provide Word templates (macros) that
    can be used to make specimen labels needed for
  • SCHARP will provide bulk blank labels (small and
  • Extra CRFs and blank labels can be ordered using
    the CRF Request Form

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?

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?

Data Management SOP, cont.
  • By whom and when will CRFs be reviewed prior to
  • 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.

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
  • Communiqués should be printed and placed in SSP
    section 15

Data Communiqués, cont.
  • First Data Communiqué for VOICE was issued on
  • Can be downloaded from MTN website

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

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)

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
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
Anatomy of a DataFax QC Report, cont.
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 ( is the CASA for

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

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

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

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

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//
  • Click on MTN logo
  • Click on MTN 003

MTN 003 Reports on Atlas
  • Click on MTN 003
  • Under MTN 003 Open Reports section, you will
    see the Site Data Management Quality Report

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
  • 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