Oncology Patient Enrollment Network OPEN Quality Assurance Lucille Patrichuk OPEN Implementation Manager OPEN Conference September 18, 2008

9/18/2008 OPEN Conference 2 Objective To ensure the accuracy of patient enrollment data within the OPEN System and the Regulatory Support System. To ensure the accuracy of patient enrollment data received by the lead organization via the OPEN portal.

9/18/2008 OPEN Conference 3 QA Process First protocol activated in OPEN for each Lead Group : – Initial enrollments will be processed by the CTSU registrars for a 4-6 week period before OPEN is available to all sites. –The first 10 enrollments in OPEN will undergo a quality control review. –Key data fields from the OPEN summary screen will be verified against the hard copies of the enrollment documents received from the site. –Key fields from the OPEN Summary Screen will be verified with Pre-Enrollment Certification Screen in RSS.

9/18/2008 OPEN Conference 4 OPEN Summary Screen

9/18/2008 OPEN Conference 5 EC Summary

9/18/2008 OPEN Conference 6 QA Process Contd. –The Credited Group will be verified in RSS according to the CTSU business rules. –Any discrepancies identified will be reviewed and clarified with the Site and/or the Lead organization involved if necessary. –Administrative changes made in RSS will be noted in the comments box and maintained in an audit trail. –No EC changes will be made in OPEN. All discrepancies impacting the Lead Group’s randomization system will be communicated to the Lead Group.

9/18/2008 OPEN Conference 7 Patient Enrollment Certification Screen Credited Group

9/18/2008 OPEN Conference 8 QA Process Contd. For subsequent protocols and updated ECs involving changes to metadata: –The first five enrollments will be reviewed. –The credited Group will be verified according the CTSU/Group business rules –The investigator will be checked against Group roster data –Key data fields from the summary screen will be reviewed to ensure data is valid. –A QC checklist will be completed for all enrollments reviewed.

9/18/2008 OPEN Conference 9 QA Process Contd. An OPEN Quality Control Log will be maintained to track enrollments that are reviewed. The QC Log will record the Protocol, PID, Date of Enrollment, and the result of the QA review. The OPEN Administrator will monitor and maintain the QC Log. Groups can verify the communication process between OPEN and their randonode through a review of OPEN summary data and Group treatment arm data.

9/18/2008 OPEN Conference 10 QA Process Contd. Reports of accrual data and treatment arm data from OPEN will be available to the Lead Organization for verification with their randomization data. Accrual data is available via CEWS and RSS.