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Oracle® Clinical Remote Data Capture Classic Data Entry User's Guide
Release 4.6.2
Part Number E18824-01
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1-1 Audit Information
1-2 Function Keys in RDC Classic
1-3 Default RDC Classic Roles
1-4 Privileges in RDC Classic
1-5 Privileges Included in Other Privileges
1-6 General Workflow for Initial Data Entry
1-7 Workflow to Save CRF in Created Status - Single-section CRF
1-8 Workflow to Save CRF in Created Status - Multiple-section CRF
1-9 Workflow to Create a CRF and Proceed to Data Entry - Single-section CRF
1-10 Workflow to Create a CRF and Proceed to Data Entry - Multi-section CRF
1-11 Workflow to Run a Report
1-12 Workflow to Unlock a CRF for Update
2-1 Method and Description to Select Visits
2-2 RDC Classic-generated Data Entry Statuses
2-3 CRF Entry Statuses Generated Externally
2-4 Discrepancy Statuses in RDC Classic
2-5 Approval Statuses in RDC Classic
2-6 Changes in Approval Status Based on Events or User Actions
2-7 Verification Statuses in RDC Classic
2-8 Changes in Verification Status Based on Events or User Actions
2-9 CRF Component Requirements for Manual Save
3-1 Types of System-generated Discrepancies
3-2 Parameters that Define Univariate Discrepancy Criteria
3-3 Types of User-generated Discrepancies
3-4 Example of Internal Discrepancy Routing
4-1 PDR Cover Page Components
7-1 Factors that Affect Group Activities
7-2 Group Activities and Required User Privileges
11-1 File Menu Commands: Descriptions and Shortcut Keys
11-2 Edit Menu Commands: Descriptions and Shortcut Keys
11-3 Insert Menu Commands: Descriptions and Shortcut Keys
11-4 CRF Menu Commands: Descriptions and Shortcut Keys
11-5 Group Activities Menu Commands: Descriptions and Shortcut Keys
11-6 Validation Menu Commands: Descriptions and Shortcut Keys
11-7 Help Menu Commands: Descriptions and Shortcut Keys
11-8 Window Menu Commands: Descriptions and Shortcut Keys
11-9 RDC Classic Toolbar Buttons
12-1 Major Components of the RDC Classic Spreadsheet
12-2 Entry Status CRF Icons
12-3 Discrepancy Status CRF Icons
12-4 Verification Status CRF Icons
12-5 Approval Status CRF Icons
12-6 Examples of Multiple Status CRF Icons
12-7 Information Displayed on Each Type of Spreadsheet View
13-1 List of RDC Classic Task Tabs
13-2 Fields and Descriptions for the Patient Summary Section
13-3 Fields and Descriptions for the Discrepancies Summary Section
13-4 Fields and Descriptions of the CRFs Summary Section
13-5 Fields and Descriptions of the CRF Status Section
13-6 Fields and Descriptions of the Visits Section
13-7 Fields and Descriptions of the Page Summary Section
13-8 Fields and Descriptions of the CRFs Section
13-9 Fields and Descriptions of the CRF Status Section
13-10 Fields and Descriptions of the CRF Summary Section
13-11 Fields and Descriptions of the Audit Summary Section
13-12 Fields and Descriptions of the Site Information Section
13-13 Fields and Descriptions of the Site CRF Information Section
13-14 Fields and Descriptions of the Study information Section
13-15 Fields and Descriptions of the Study CRF Information Section
13-16 Categories and Fields for Section Spreadsheet View Summary Task Tab
13-17 Components of the List of Discrepancies Tab
13-18 Components of an Individual Discrepancy Tab
13-19 Components of the Verification Task Tab for CRFs w/ Status Not Verified
13-20 Components of the Verification Task Tab for CRFs w/ Verification History
13-21 Components of the Approval Task Tab for CRFs w/ Status Not Approved
13-22 Components of the Approval Task Tab for CRFs with Approval Histories
13-23 Components of Audit Trail Tab
14-1 Components of the Launch Page
14-2 Components of the Logon Window
14-3 Components of the Change Password Window
14-4 Components of the Select Study Window
14-5 Components of the Editor Window
14-6 Components of the Search and Replace Window
14-7 Patient Node Icons
14-8 Components of the Save Current Search Window
14-9 Components of the List of Saved Searches Window
14-10 Components of the Maintain Search Window
14-11 Components of the Copy Search Window
14-12 Components of the SQL Query Window
14-13 RDC Classic Date Formats
14-14 Reports Window Components
14-15 Report Submission Window Components
14-16 List and Description of Report Parameters
14-17 Verification Status Choices Parameter
14-18 Submitted Batch Jobs window Components
14-19 Components of the Current CRF Lock Process Window
14-20 Components of the Users with Privileged Update Window
14-21 Components of the Valid User Names Window
14-22 Components of the Group Verification Windows
14-23 Components of the Group Approval Windows
14-24 Components Password Confirmation Window
14-25 Components Group Lock Processing Window
14-26 Components of the Insert New Patient Window
14-27 Components of the Add Unplanned CRF Window
14-28 Components of the Content Frame Toolbar
15-1 Components of the Search Window
15-2 Patients Subsearch Window Components
15-3 Visit/Page Range Subsearch Window Components
15-4 CRF Status Subsearch Window Components
15-5 CRF Status Parameter Settings
15-6 Discrepancy Status Parameter Settings
15-7 Verification Status Parameter Settings
15-8 Approval Status Parameter Settings
15-9 Lock Status Parameter Settings
15-10 CRF /Visit Dates Subsearch Window Components
15-11 CRFs/Discrepancies Parameter Settings
15-12 Created/Modified Parameter Settings
15-13 Time Frame Parameter Settings
15-14 Data Subsearch Window Components
15-15 Values for the Relational Operators in the Data Subsearch Window
15-16 Descriptions of the Comment Type Parameter Options
16-1 Major Components of the Data Entry Window
16-2 Functionality of Menu Commands in the Sizing Window
16-3 Display Conditions for Audit Information Windows
16-4 Audit Information History Window Components
16-5 Listing and Descriptions of Components in the Audit History Window
16-6 Password Confirmation Window Components
16-7 Password Confirmation Window Components
16-8 List of Windows Used for Univariate and Manual Discrepancies
16-9 Components of the Discrepancy for CRF Page Window
16-10 Components of the Comment for Question Window
16-11 Components of the Validation Failure Window
16-12 Internal Comment Windows Functionality and Access
16-13 Components of the Internal Comments Window
16-14 Components of the Internal Comment History Window
16-15 Components of the Internal Comments for Discrepancy Window
16-16 Components of the Resolution Reason Window
16-17 Discrepancy History Window Components
17-1 RDC Classic Discrepancy Icons and Statuses
17-2 User Groups and Default RDC Classic Discrepancy Statuses
17-3 Default Discrepancy Actions for User Group DM
17-4 Sample DATA CHANGE REASON TYPE CODE Updates
17-5 Customizable Univariate Discrepancy Messages
17-6 Substitution Variables for Univariate Discrepancy Messages
17-7 Contents of Package RDC_CLIENT
18-1 Functional Privileges for RDC Classic
18-2 Sample Privilege Assignments
19-1 Scope, Number of Nodes, and Explanation
19-2 Columns and Field Values for Example Activity
19-3 RDC_USER_ACTIVITY_VIEW Query
19-4 Columns in the RDC_ACTIVITIES Table
19-5 Columns in the RDC_ACTIVITY_TAGS Table
19-6 Columns in the RDC_ACTIVITY_COLUMN Table