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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
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Online
Data Management System:Navigating the ACRIN Website
http:// www.acrin.org
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Select the tab titled: Protocol Summary Table
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Case Report Forms
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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
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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
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Data Center Login
Accessing the Data Center
Web form Data Entry System
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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.
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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.
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View Patient Calendar
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Select Data Collection to view forms expected for submission through the ACRIN website
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Data Collection
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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
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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
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Site Ops Tool
View listings of outstanding or projected forms on calendars across a study or case.
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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)
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Forms Due Report
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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
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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
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Z1: Request for Additional Information
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Revise-It http://www.acrin.org
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Example: study 4701
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Revise to “No”
Please Note: •When revising incorrect data, checks are in place (future dates, ranges, etc. that could generate a query)
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• 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.
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• 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.
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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.
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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.
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GCPs
Good Clinical Practices: Documentation
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Incorrect GCP
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Correct GCP
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Questions ?