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 participant’s
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 it’s 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 site’s 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
site’s QC rate
• Molly Swenson (mollys@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 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, 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@scharp.org
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 Questions???

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