1. Oncology Patient Enrollment Network OPEN OPEN Documentation Lucille Patrichuk OPEN Implementation Manager OPEN Conference September 18, 2008

2. 9/18/2008 OPEN Conference 2 Scope Documentation of procedures is a critical component of efficient operations, quality control and regulatory compliance. CTSU will provide Lead Organizations with the documentation necessary to ensure that enrollments performed in OPEN are processed accurately, consistently and in accordance with NCI, Lead Group and CTSU policies.

3. 9/18/2008 OPEN Conference 3 Scope contd. CTSU will provide Lead Group and Institutional site staff with detailed instructions and training tools necessary to perform enrollments in the OPEN system. CTSU will provide documentation to ensure that procedures are in place for business continuity and system back up and recovery. CTSU will provide documentation to ensure that quality control procedures are in place and that processes are followed.

4. 9/18/2008 OPEN Conference 4 Procedures OPEN OPERATIONAL DOCUMENTATION LIST 1.Defining Protocol Specific Requirements in RSS 2.Form Definition in OPEN 3.Edit Specifications in the OPEN System 4.OPEN Business Rules for Access and Crediting 5.OPEN Patient Enrollment and Treatment Assignment 6.Override Procedure in the OPEN System 7.Quality Assurance of Patient Enrollments in the OPEN System 8.CTSU Support Service for OPEN 9.Data Corrections and updates in OPEN 10.Protocol Amendment Management in OPEN 11.OPEN Change Management Procedure

5. 9/18/2008 OPEN Conference 5 Procedures contd. OPEN IT DOCUMENTATION LIST 1. OPEN Portal System Requirements 2.OPEN Portal System Design 3.OPEN Portal System Traceability Matrix 4.Deployment Guide 5. Systems Security Overview 6. Business Continuity and Disaster Recovery Plan 7.Database Backup and Recovery Policy 8 Database Audit Policy

6. 9/18/2008 OPEN Conference 6 Procedures contd. OPEN USER RESOURCES 1.Administrator User Guide 2.Registrar User Guide 3.OPEN Training Demo 4.OPEN Trailer Documentation will be stored on the OPEN Portal URL: http://www.ctsu.org/open/

7. 9/18/2008 OPEN Conference 7 Discussion