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

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

3. Select the tab titled: Protocol Summary Table

7. Case Report Forms

8. Form Completion Instructions  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

13. Adverse Event Reporting  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

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. 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. Example: study 6685

35. 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 Online Entry Tips

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.  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 Forms Due Report

46.  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 Data Queries

47. Z1: Request for Additional Information Z1 Query Template

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

54. Example: study 4701

55. Revise to “No” Please Note: When revising incorrect data, checks are in place (future dates, ranges, etc. that could generate a query)

57. Query Response: Applies to a Z1 Applies to a ZW (Excel spreadsheet) Site Revision: Applies to a random update to a form by the site. Audit QC Finding Correction: Applies to data revisions found during a site audit. Query Response: Applies to a Z1 Applies to a ZW (Excel spreadsheet) Site Revision: Applies to a random update to a form by the site. Audit QC Finding Correction: Applies to data revisions found during a site audit.

58. If “Query Response” is selected, a prompt will appear instructing users to select the appropriate/corresponding query. All due dates for outstanding queries for the case will be listed at the bottom of the screen. Check the due date of the query that applies to the revision. When finished, select the “Save and Submit” button. To cancel revisions, select the “Correct Form” button.

59. Once revisions are submitted/saved, a confirmation e- mail will be generated which includes two attachments: Completed revised form with a version number which will change with subsequent revisions to a form. Summary form showing only the changes that were made during that particular session. An example of the e-mail and attachments will be presented by ACRIN 6684 on the next couple of slides.

63. Additional Information Needed: Does not apply to multiple occurring forms (ex: AE). Revisions to these forms must be faxed to ACRIN. Remember: When revising data, make sure to correct the source document using GCP guidelines. (Line thru the error, write corrected data, date and initial the change). The corrected CRF is required to be sent back to ACRIN.

64. GCPs Good Clinical Practices: Documentation

65. Incorrect GCP

66. Correct GCP

67. Questions ?