Online Data Management System: Navigating the ACRIN Website acrin

1. ACRIN 6698Diffusion-weighted MRI Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: An I-SPY 2 Trial SubstudyPresented by: Roberta Clune, Lead Data Manager

2. Online Data Management System: Navigating the ACRIN Website http:// www.acrin.org

3. Select the tab titled: Protocol Summary Table

7. Case Report Forms

8. Available on the 6698 Data Forms Website Refer to the General Form Completion Instructions for a detailed process of ACRIN form completion, submission and revision Form specific completion instructions also available Form Completion Instructions

13. For this trial: Refer to Protocol Section 10.0 for when and how to report Please contact the primary Data Manager of the study to guide you through the reporting process Adverse Event Reporting

16. Data Center Login Accessing the Data Center Web form Data Entry System

18. Up to 2 unique logins and user passwords will be given to each site prior to patient enrollment. Please contact the 6698 Project Manager, Deb Harbison, if this has not been provided.

24. Select the View Patient Calendar link to view each participant calendar. The calendar lists all data expected for submission, i.e. data forms, images, and reports when applicable. The calendar is updated upon data submission.

25. View Patient Calendar

30. Select Data Collection to view forms expected for submission through the ACRIN website

31. Data Collection

34. Example: study 6685 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. 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.

35. Online Entry Tips Error message boxes appear specific to: Mandatory values Validity Checks Date Discrepancies Processing a form Submit: processes the form Clear: will clear the form Delete: will delete the current form and return to previous page Email confirmation is sent upon successful form submission

36. Site Ops Tool View listings of outstanding or projected forms on calendars across a study or case.

40. Example of study 6682 Form Occurrence Single: A form code that may appear several times on the participant calendar but each with an individual due date. (Ex: TM form) Multiple: A form code that appears once on the participant calendar but with multiple case records contained within the form. Each case record has an individual due date (Ex. AE form)

43. Forms Due Report

44. Forms Due Report Request for outstanding data Encourage prompt submission of data, reports, and images Affords an opportunity to resolve discrepancies between the Institution's records and the Data Management Center A listing of each item that has not been received by a specified deadline Sent to the PI and RA of record for a protocol Can be run by the site through the SiteOps tool

46. Data Queries Generated when: Inconsistencies exist Confirmation of data entered is necessary Mandatory data fields are incomplete E-mailed to site RA Protocol, case, form, question specific Due Date is the date query is sent to the site Respond in timely manner

47. Z1 Query Template Z1: Request for Additional Information

48. Revise-It http://www.acrin.org