ACRIN 6698Diffusion-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

Online

Data Management System:Navigating the ACRIN Website

http:// www.acrin.org

Select the tab titled: Protocol Summary Table

Case Report Forms

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

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

Data Center Login

Accessing the Data Center

Web form Data Entry System

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.

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.

View Patient Calendar

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

Data Collection

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

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

Site Ops Tool

View listings of outstanding or projected forms on calendars across a study or case.

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)

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

Forms Due Report

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

Z1: Request for Additional Information

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

Example: study 4701

Revise to “No”

Please Note: •When revising incorrect data, checks are in place (future dates, ranges, etc. that could generate a query)

• 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.

• 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.

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.

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.

GCPs

Good Clinical Practices: Documentation

Incorrect GCP

Correct GCP

Questions ?