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MTN 003 Data Management Considerations

This document provides an overview of key data management considerations for MTN 003, including contents of the study's SSP sections related to data management, CRF supplies, site data management procedures, Data Communiqués, and reports produced by SCHARP. It discusses in detail the various CRF packets, ordering more forms, the CRF Request Form, and site SOPs for data collection and management. It also summarizes the QC and Clinical QC reports produced by SCHARP and reviewed by sites.

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Muazam Ali
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21 views30 pages

MTN 003 Data Management Considerations

This document provides an overview of key data management considerations for MTN 003, including contents of the study's SSP sections related to data management, CRF supplies, site data management procedures, Data Communiqués, and reports produced by SCHARP. It discusses in detail the various CRF packets, ordering more forms, the CRF Request Form, and site SOPs for data collection and management. It also summarizes the QC and Clinical QC reports produced by SCHARP and reviewed by sites.

Uploaded by

Muazam Ali
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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MTN 003

Data Management
Considerations

SSP Sections
14, 15 & 17

1
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)

2
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)

3
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

4
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

5
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
6
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

7
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

8
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

9
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)

10
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
11
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?

12
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?

13
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.
14
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
15
Data Communiqués, cont.
• First Data Communiqué for VOICE
was issued on 09-SEP-09
• Can be downloaded from MTN
website

16
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
17
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)
18
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

19
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

20
Anatomy of a DataFax QC
Report, cont.

21
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 ([email protected]) is the
CASA for VOICE

22
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

23
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
24
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
25
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
26
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
27
MTN 003 Reports on Atlas

• Click on MTN 003


• Under “MTN 003 Open Reports” section, you will see the
Site Data Management Quality Report

28
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
[email protected]
29
Questions???

30

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