ACRIN 6666: Breast Ultrasound Screening Trial Friday, October 6, 2006

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

ACRIN Home Page: Protocol, Registration, Accrual Access to protocol summary and summary of changes

ACRIN Home Page: Protocol, Registration, Accrual Access to protocol summary and summary of changes

Clicking on 6666 link automatically scrolls to 6666 web page. Protocol specific Enrollment updates will be projected within accrual column.

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.

Each form link gains access to PDF printable data forms Forms update, current version of forms, and all standard forms are posted for printing

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

Access to all Protocol registration Access to all Protocol registration and data form modules.

Logon ID and passwords are received and activated once all administrative documents for site participation within a protocol have been received at ACRIN Headquarters.

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.

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).

Depressing the Data Collection link gains access to the study and case screen

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. Depressing the form link gains access to the form web screens

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

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.

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.

Use ops tool to view outstanding or projected forms on calendars across study or case

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

THANK YOU for providing quality data

Common form errors and how to avoid queries

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.

Time point in study correlates to date of mammogram based on registration time points and procedure dates are critical in analysis for this study

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.

Use lesion enumerated on prior Mammogram or US and 998 only when it is truly N/A.

Common form questions

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.

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.

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.

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.

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

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.

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.

Use PR form to report variations for events such as participant went to non-ACRIN facility to have mammogram, withdrew from study.

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

6666 Data Management Contacts Karan Boparai, RT (R) (M), Senior Research Associate Phone: Stephanie Clabo, Research Associate Phone Glenna Gabrielli, BS, MT, Research Associate Phone: Judy Green RT (R) (M), Research Associate Phone:

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?] Reminder from Data Managers When submitting data revisions

ACRIN 6666: Breast Ultrasound Screening Trial MRI Forms Friday, October 6, 2006

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.

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#

Lesion recommendation other than routine prompts additional form MX

Use dates of current mammogram, US and MRI for integration read 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.

Recommendation for right/left breast on MX form may prompt additional forms.

additional forms [F6, M4, BX, etc.] may generate based on recommendation REVISED IM and F6

REVISED FORM MRI finding # added

Additional MRI guided responses added for BX form

NL form revisions similar to BX form revisions 6month follow-up MRI--M4 form similar to M3 form

CEA form