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1 RDC Roles and Responsibilities RDC has several basic roles that are available to users that enter, update, review and approve data. Site User Data Entry Responds to queries Principal Investigator Reviews CRF data Approves CRF pages May provide data entry (train as Site User and request these privileges) CRA/Site Monitor Reviews data and source documents Issues manual queries Reviews queries (as needed) Verifies CRF pages Data Management Reviews Data Issues Queries Resolves Data Issues and Queries (as needed) RDC Quick Launch Kit V1.0 5 of 70 RDC Quick Launch Kit V1.0 5 of 127

2 RDC Definitions CRF A data entry page in RDC is called the CRF. Sometimes referred to as ecrf or page in RDC Casebook Discrepancy Manual Queries System Queries Batch Validation Verification Approval Saved CRF A collection of CRF pages available for data entry A discrepancy is data that falls outside of an expected range of values Discrepancies Queries Queries that are generated by the DM or CRA within RDC Queries that are generated by RDC as the result of programmed RDC edit checks These queries can appear when a CRF is saved or after Batch Validation (see Batch Validation) A process that executes all edit checks built into the database to cross-check multiple data fields possibly on multiple case report forms Verification in RDC verifies that a CRA has monitored source data and resolved outstanding data issues on a CRF, also referred to as Source Document Verification or SDV The electronic equivalent in RDC of the Investigator Signature for a CRF page, and for all the data corrections and queries resolved A CRF page saved with data Blank CRF A CRF page saved without data using the Blank Page tool in RDC RDC Quick Launch Kit V1.0 6 of 70 RDC Quick Launch Kit V1.0 6 of 127

3 How Biogen Idec RDC differs from Paper Studies Many sites are already familiar with Biogen Idec studies but use paper CRFs instead of RDC. There are some similarities and differences between RDC studies and paper studies! The look! Biogen Idec RDC has CRF pages that look similar to paper CRFs. RDC Quick Launch Kit V1.0 7 of 70 RDC Quick Launch Kit V1.0 7 of 127

4 Pop-Up Calendar RDC has a pop-up calendar function. RDC Quick Launch Kit V1.0 8 of 70 RDC Quick Launch Kit V1.0 8 of 127

5 List of Values RDC also has Check box functionality and drop down menus that can be used to pick from a list of values for entering data. RDC Quick Launch Kit V1.0 9 of 70 RDC Quick Launch Kit V1.0 9 of 127

6 Indicator Pages RDC also has separate Indicator pages with leading questions that allow sites to enter YES to indicate that more information is expected on a corresponding CRF. N O can be entered when additional data is not available and the site will not enter any additional data. RDC Quick Launch Kit V of 70 RDC Quick Launch Kit V of 127

7 Log Style CRFs Many Biogen Idec paper studies use log style CRFs. These pages usually have line numbers that allow the site and data management to reference a specific entry when providing data revisions or resolving queries. In RDC the line numbers are no longer present. RDC Quick Launch Kit V of 70 RDC Quick Launch Kit V of 127

8 Date of Visit CRFs RDC studies also include a Date of Visit page for all scheduled visits. This page will always be the first page in a visit. RDC Quick Launch Kit V of 70 RDC Quick Launch Kit V of 127

9 RDC Data Flow Data entered into RDC Data reviewed and queries issued by: - System - Data Management All data updated and all queries resolved RDC data source document verified by CRAs RDC data reviewed and approved by Investigators Clean Trial Data - CRAs RDC Quick Launch Kit V of 70 RDC Quick Launch Kit V of 127

10 RDC Expectations For Data Entry During the study 5 business days Six weeks prior to database lock 2 business days Two weeks prior to database lock 1 business day Week of database lock within 1 business day Do not let data entry accumulate! RDC Quick Launch Kit V of 70 RDC Quick Launch Kit V of 127

11 RDC Expectations For Query Management During the study 10 business days Six weeks prior to database lock 2 business days Two weeks prior to database lock 1 business day Week of database lock within 1 business day Manage queries between monitoring visits! RDC Quick Launch Kit V of 70 RDC Quick Launch Kit V of 127