ACRIN 6666: Breast Ultrasound Screening Trial

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ACRIN 6666 Breast Ultrasound Screening Trial

• Friday, October 6, 2006

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• Navigating the ACRIN web site
• Registration/Data collection
• Case specific calendars
• Form review
• Data Management

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Access to protocol summary and summary of changes
ACRIN Home Page Protocol, Registration, Accrual
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ACRIN Home Page Protocol, Registration, Accrual
Access to protocol summary and summary of
changes
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Clicking on 6666 link automatically scrolls to
6666 web page.
Protocol specific Enrollment updates will be
projected within accrual column.
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Access to the protocol, minus the statistical
section
Access to ACRIN personnel Administration,
Project Managers, Statistical Center Personnel,
Auditors and Data Managers.
The Current Protocols screen provides links to
the Protocol Summary, Protocol Resources,
Protocol Specific Application and at study
activation, the PDF versions of all forms. All
documents and forms within the links are print
ready.
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Forms update, current version of forms, and all
standard forms are posted for printing
Each form link gains access to PDF printable
data forms
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• Navigating the ACRIN web site
• Registration/Data collection
• Case specific calendars
• Form review
• Data Management

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Access to all Protocol registration and data
form modules.
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Logon ID and passwords are received and activated
once all administrative documents for site
participation within a protocol have been
received at ACRIN Headquarters.
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To retry, clear input in the logon ID box and
the Password box, then re-enter information. If
denial persists, contact the ACR to verify Logon
ID or troubleshoot other possible reasons for
access denial.
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The site Institution No. is a direct link to the
Main Menu. Click on the Institution to proceed
(the Institution number is directly linked to
the username and password).
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Depressing the Data Collection link gains access
to the study and case screen
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Depressing the form link gains access to the form
web screens
The Data Collection screen only lists forms
expected for submission through the ACRIN
website. Upon submission of the form through
the web, the received date is updated and the
form is removed from the Data Collection screen,
the receipt of the form is also updated within
the View Calendar screen.
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• Navigating the ACRIN web site
• Registration/Data collection
• Case specific calendars
• Form review
• Data Management

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Participant specific calendars are generated
with each case enrolled. The calendar identifies
all data forms, images and reports due for
submission based on entry. All forms are
referenced by name, two letter ID, due date,
assessed date and the received date. Submitted
forms may trigger additional forms generation to
the calendar.
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The View Calendar lists all data expected for
submission specific to the case, i.e. data forms,
images, etc. The calendar is dynamically updated
based on data submission.
Note the View Patient Calendar is static, data
entry of forms is only through the Data
Collection link.
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Use ops tool to view outstanding or projected
forms on calendars across study or case
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• Navigating the ACRIN web site
• Registration
• Case specific calendars
• Form review
• Data Management

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THANK YOU for providing quality data
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Common form errors and how to avoid queries
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Note Q3a record actual months since study entry.
If the participant has not returned and the form
is being completed for the 12 month screening at
16 months after the participant entered the
study, 16 is to be entered not 12.
Describe any new or suspicious findings first.
Use next sequential lesion number for new
lesions. Retain lesion number consistency when
describing a previously enumerated lesion.
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Time point in study correlates to date of
mammogram based on registration
time points and procedure dates are critical in
analysis for this study
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Ensure consistency between lesion number and
breast reported e.g. Lesion reported as ML2
and location Q10d described as Right will
result in a query.
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Use lesion enumerated on prior Mammogram or US
and 998 only when it is truly N/A.
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Common form questions
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Q The participant did not have the procedure
performed, would you please suppress the
form? A If the participant did not have the
procedure performed the form is still required to
be submitted stating the participant did not
return and the reason why.
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Q The participant told me she has had bilateral
mastectomy since her last exam, would you please
suppress the forms? A If the participant has had
bilateral mastectomies please submit a PR form
stating the participant has had bilateral
mastectomies. In addition complete and submit
the S1 forms for the surgical procedures. All
data due up to the time of mastectomies should
also be submitted. Once all data requirements
are satisfied, forms not expected will be
suppressed and the case status changed.
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Q I contacted the participant for her annual
follow-up studies and she told me she already had
her mammogram at another facility due to
insurance changes. What should I report on this
participant?
A Schedule the participant for the whole breast
US, obtain the mammogram films and have an ACRIN
reader complete the IA form based on his/her
interpretation without knowledge of outside read.
Submit a PR form stating the participant went to
non-ACRIN facility, submit another PR form
stating study double read.
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Q I tried to contact the participant for her
annual follow-up studies and have been unable to
contact her. I submitted PR forms stating she
withdrew, why is the calendar and forms due
report still showing her forms as outstanding?
Why have the forms not been suppressed yet? A
Case status is not changed to withdrawn unless
the participant truly withdrew. If the
participant is not able to be contacted, forms
need to be submitted stating the participant did
not return and the reason specified.
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Distinction between withdrawing from the study,
and continuing to provide information but not
following imaging procedures. If a participant
wishes to withdraw from the study they no longer
wish to be contacted nothing further to do with
the study no further data collection or contact
PR form submitted stating participant
withdrew case status is changed to withdrawn and
suppress the appropriate forms If a participant
is willing to provide information for the study
but does not wish to return for imaging they are
not withdrawing  as much data as can be
collected needs to be collected and reported
the case status remains open eligible.  the
appropriate imaging form submitted as the
participant did not return for imaging and the
reason  Allows continuous follow-up information
for participant
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Q Participant registered in 11/2004 and had her
imaging. She had her 12 month follow-up studies
11/2005 but upon calling her to schedule her 24
month screen, I have found she had her mammogram
and a targeted US in June 2006 due to a clinical
abnormality. Should I fill out the IM for the
off-study event and report the IA/IS as not
done? A Complete and submit an IM form for the
off-study event. Try to have the participant
return for the 24 month US and mammogram even if
it is a little past the 24 month timeframe due to
insurance concerns for the mammogram.

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Q I called the participant for her follow-up
studies and she told me she has had bilateral
implants. Does that make her ineligible? A No,
eligibility is determined at time of study entry.
Anything that happens after the participant
enrolled does not make her ineligible. Data
should still be collected on this participant.
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Use PR form to report variations for events such
as participant went to non-ACRIN facility to have
mammogram, withdrew from study.
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• Navigating the ACRIN web site
• Registration
• Case specific calendars
• Form review
• Data Management

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6666 Data Management Contacts

• Karan Boparai, RT (R) (M), Senior Research
  Associate
• Phone [phone]
• E-mail kboparai_at_phila.acr.org
• Stephanie Clabo, Research Associate
• Phone -901-752-4588
• Email - sclabo_at_phila.acr.org
• Glenna Gabrielli, BS, MT, Research Associate
• Phone [phone] E-mail ggabrielli_at_phila.acr
  .org
• Judy Green RT (R) (M), Research Associate
• Phone [phone]E-mail jgreen_at_phila.acr.org

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Reminder from Data Managers When submitting data
revisions

• Submit only the revised pages
• Label pages with form type, study number and case
  number
• Submit revisions on the appropriate form instead
  of GCM
• Submit supporting documentation with Z1 responses
• Sign and date Z1s when returning responses to HQ.
• Review entire form when submitting revisions to
  assess data correlation within form or across
  forms e.g. does the revision result in a
  revision on another area of the form or on
  another form?

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ACRIN 6666 Breast Ultrasound Screening
Trial MRI Forms Friday, October 6, 2006
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Submit A2 for all open eligible participants
including those not participating on MRI study
and specify reason. Yes response in Q2 triggers
M3 form to calendar. Participant does not need to
sign form if not participating.
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One form for each lesion/breast even if not on
study - this is different from other study
6666 forms where everything was on the same form.
This is a multiple form. Access from the data
collection screen as many times as needed.
Lesions are GR or GL
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Lesion recommendation other than routine prompts
additional form MX
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Completed by a qualified investigator radiologist
after the IA, IS, and M3 forms have been
completed, if the M3 reports findings other than
routine follow-up. The 24 month study mammograms,
US, and screening MR are interpreted together,
along with any additional views or targeted US
performed based on the 24 month study mammogram
and US, but without knowledge of any biopsy
results prompted by the 24-month study US or
mammogram. Additional workup prompted by the MRI
should be reported on an IM form.
Use dates of current mammogram, US and MRI for
integration read
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Recommendation for right/left breast on MX form
may prompt additional forms.
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REVISED IM and F6
additional forms F6, M4, BX, etc. may generate
based on recommendation
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MRI finding added
REVISED FORM
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Additional MRI guided responses added for BX form
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NL form revisions similar to BX form
revisions 6month follow-up MRI--M4 form similar
to M3 form
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CEA form
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CEA form