Table of Contents
- Title and Copyright Information
- Preface
-
Part I Configuration Tasks
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1
Setting Up User Accounts
- Creating an Administrator User Account
- Running the Add User Script
- Running the Migrate Users Script
- Adding or Revoking OCPSUB Access
- Maintaining Oracle User and Group User Accounts
- Granting Data Access to User and Group User Accounts
- Granting Data Access to RDC Users
- Granting Additional Database Roles to User Accounts
- Setting Up Data Extract Users
- Setting Up PSUB Administrator Users
- Setting Up Power Users
- Changing Passwords
- Setting Password Requirements for User Accounts
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2
Oracle Clinical Menu-Based Security
- Predefined Database Roles
- Creating and Modifying Database Roles
- Adding Menu Items to Oracle Clinical
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3
Configuring Discrepancy Management
- Mapping Database Roles to User Roles
- Customizing Layout Definitions
- Customizing Profiles
- Customizing Flexfields
- Defining Reason Codes for Discrepancies
- Defining the Possible Review Statuses for Discrepancies
- Defining Resolution Reasons for Discrepancies
- Setting Values in the OCL_STATE Local Reference Codelist
- Configuring Role-Specific Discrepancy Management for RDC
- Configuring Study and Site Security for Oracle Clinical Discrepancy Management
- Setting Up Data Clarification Forms (DCFs)
- Creating Reusable Standard Text for Discrepancies and DCFs
- 4 Configuring the Mass Changes Utility
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5
Configuring Data Entry and User Preferences
- Customizing Data Entry Behavior
- Customizing the Oracle Clinical Log-in Window Layout
- Scheduling a Job to Manage Patient Updates
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Setting DCI Form Default Values for RDC Data
Entry and Patient Data Reports
- Setting and Enforcing Values
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Settings
- DCI Form Definition
- DCI Form Runtime
- General
- Graphic Layout Editor/Updater
- Graphic Layout Generator - General
- Graphic Layout Generation - DCMS
- DCI Form Generation Defaults
- Default Settings for Showing DCM Header Fields
- Default DCM Header Field Prompts
- Version Migration
- Patient Data Report
- Validation
- Options in Group Verify dialog
- Options in Group Approve dialog
- Source Data Verification Plan
- Default DCI Custom Review Requirements
- Configuring Custom Review Types
- Customizing Flex Fields for DCI Forms
- Customizing Online Help
- Viewing Online Help Without Oracle Clinical
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6
Configuring Data Extract
- Adding the opapps User to the OCLSASCR User Group
- Authenticating the SAS Connection
- Regenerating SAS Views Created in Pre-5.0 Oracle Clinical Releases
- Creating SAS Output File Directories
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Configuring Default Installation Data Extract Settings
- Separate Oracle and SAS Names?
- DCM Default Views Are Linked to Source DCM as Default Condition?
- Enable Templates?
- Enable Selection of Aggregate, Nondefault Key Template?
- Include View Definition?
- Enable Update of SAS and Oracle Column Names?
- Enable View Builder as Default in New Studies?
- Use DCM Question-Specific DVG Subset for DVG Attributes?
- Use DCM SAS Label as Seed for Attributes in Default View Definition?
- Max Length of Audit Comment
- Max length of Data Comment
- Max Length of DVG Long Value
- Default Key Template
- Key Template Domain
- Build Fast Views?
- Setting Values in Data Extract-Related Reference Codelists
- Creating Tablespaces for Data Extract Tables and Indexes
- Customizing Data Extract Views
- Generating Data Extract Views
- Enabling the View Builder and Converting Views
- Controlling Access to Data Extract Views
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7
Reference Codelists
- Overview of Reference Codelists
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Local Reference Codelists
- BATCH QUEUE NAME Local Codelist
- DB_LINKS Local Codelist
- DCF COMMENT TEXT Local Codelist
- DCF DEFAULT FOOTERS Local Codelist
- DCF DEFAULT HEADERS Local Codelist
- DCF REPORT LABELS Local Codelist
- DISC COLS Local Codelist
- DISC_FLEX1 and DISC_FLEX2 Local Codelists
- DISC_FLEX1_VALUES and DISC_FLEX2_VALUES Local Codelists
- FLD RXCMCMCD RDCI DELETE Local Codelist
- FLD RXCMCMCD RDCI KEY Local Codelist
- FLD RXCMCMCD RDCM KEY Local Codelist
- FLD RXCMCMCD RESPONSE Local Codelist
- IND DISC COLS Local Codelist
- MAN DISC COLS Local Codelist
- MANHD DISC COLS Local Codelist
- MC CDS SORT ORDER Local Codelist
- MC COLUMNS Local Codelist
- MULTI DISC COLS Local Codelist
- NLS_CONFIG Local Codelist
- OCL_DE_CONFIG Local Codelist
- OCL_DE_PREFS Local Codelist
- OCL_JOB_PREF Local Codelist
- OCL MC PREFS Local Codelist
- OCL_MENU_ACCESS Local Codelist
- OCL_STATE Local Codelist
- PRINT QUEUE NAME Local Codelist
- PUBLIC_DB_LINKS Local Codelist
- RDC CONFIGURATION Role Local Codelists
- REPORT_SERVER Local Codelist
- SAS_QUEUE Local Codelist
- SQL FUNCTIONS Local Codelist
- TMS_DSI Local Codelist
- TMS_OPTIONS Local Codelist
- UNI DISC COLS Local Codelist
- WEB_DOCUMENT_CONFIG Local Codelist
- WEB_DOCUMENT_GROUPS Local Codelist
- PDR_FILE_NAMING Local Codelist
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Installation Reference Codelists
- APPLICATION AREA CODE Installation Codelist
- APPLICATION SYSTEM NAME Installation Codelist
- APPROVE VERIFY RETAIN CODE Installation Codelist
- APPROVE VERIFY REVERSE CODE Installation Codelist
- BLIND TYPE CODE Installation Codelist
- CLINICAL PHASE Installation Codelist
- COUNTRIES Installation Codelist
- CRF PAGE NUMBERING SCHEME Installation Codelist
- CRF PAGE STATUS CODES Installation Codelist
- CRF PAGE STATUS QUERY Installation Codelist
- CUSTOM REVIEW TYPE Installation Codelist
- DATA CHANGE REASON TYPE CODE Installation Codelist
- DATA CHANGE REASON2 TYPE CODE Installation Codelist
- DCF LOCK CONDITIONS Installation Codelist
- DCF OPTIONAL STATUS CODES Installation Codelist
- DCF STATUS CODES Installation Codelist
- DCIF CHECKBOX SIZE Installation Codelist
- DCIF FONT TYPESIZE Installation Codelist
- DCIF PAGE DEFINITION Installation Codelist
- DCM DCI QG TYPE CODE Installation Codelist
- DISCREPANCY ACTIONS ROLE Installation Codelist
- DISCREPANCY MESSAGES Installation Codelist
- DISCREPANCY NO OTHER UPDATE Installation Codelist
- DISCREPANCY RESOLU TYPE CODE Installation Codelist
- DISCREPANCY REV STATUS CODE Installation Codelist
- DISCREPANCY STATUS ROLE Installation Codelists
- DISCRETE VAL GRP TYPE CODE Installation Codelist
- DISC_STDST_VALUES Installation Codelist
- DOSE FORM TYPE CODE Installation Codelist
- DOSE FREQUENCY TYPE CODE Installation Codelist
- DX_CONFIG Installation Codelist
- DX_EXTENDED_ATTRIBUTES Installation Codelist
- DX_INDEX_TABLESPACE Installation Codelist
- DX_KEY_NAME Installation Codelist
- DX_ROLES Installation Codelist
- DX_VIEW_TABLESPACE Installation Codelist
- EXP DESIGN TYPE CODE Installation Codelist
- EXTERNAL_TRANS_TYPE Installation Codelist
- LAB RANGE SUBSET CODE Installation Codelist
- MANUAL SOURCE TYPE CODE Installation Codelist
- MAPPING_TYPE Installation Codelist
- MEDICAL EVAL TYPE CODE Installation Codelist
- OBJECTIVE TYPE CODE Installation Codelist
- OCL_DOMAINS Installation Codelist
- OCL_INSTALLATION Installation Codelist
- OCL_OPTIONS_TYPE_CODE Installation Codelist
- OPA_MENU_ROLES Installation Codelist
- PATIENT STATUS CODE Installation Codelist
- PLAN STUDY INT TYPE CODE Installation Codelist
- PROCEDURE TYPE CODE Installation Codelist
- QUESTION CATEGORY TYPE CODE Installation Codelist
- RDCI CHANGE REASON TYPE CODE Installation Codelist
- RDCI CHANGE REASON2 TYPE CODE Installation Codelist
- REGION TYPE CODE Installation Codelist
- RETIREMENT REASON TYPE CODE Installation Codelist
- ROUTE OF ADMIN TYPE CODE Installation Codelist
- SAS_FORMATS Installation Codelist
- SINGLE DCI TYPES Installation Codelist
- SOURCE LOCATION CODE Installation Codelist
- STANDARDS AFFIL TYPE CODE Installation Codelist
- STUDY STATUS TYPE CODE Installation Codelist
- TMS_CONFIGURATION Installation Codelist
- TMS_LANGUAGES Installation Codelist
- TMS_QUERY_TYPE Installation Codelist
- TMS_SOURCE_MAT_VIEWS Installation Codelist
- TMS_TAL_POOL_CONFIGURATION Installation Codelist
- TMS_X_SEARCH Installation Codelist
- TREAT CHG REASON TYPE CODE Installation Codelist
- UNITS_OF_MEASURE_TYPE_CODE Installation Codelist
- USER GROUP ROLES Installation Codelist
- USER GROUPS Installation Codelist
- VALIDATION FAILURE TYPE CODE Installation Codelist
- Design Installation Reference Codelists
- System Reference Codelists
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1
Setting Up User Accounts
-
Part II Oracle Clinical Administration Tasks
-
8
Managing Batch Jobs
- Account Requirements for Batch Jobs
- How PSUB Handles a Request
- Securing PSUB
- Using PSUB in a RAC Environment
- Starting and Stopping PSUB
- Managing the PSUB Process
- Required Reference Codelist Settings for Batch Jobs
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9
Partitioning and Indexing
- Introduction
- Planning for Partitioning
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Partitioning the Responses Table
- Step 1. Back Up the Database
- Step 2. Export the Responses Table
- Step 3. Prepare the Database
- Step 4. Import Responses Data
- Step 5. Compute Statistics on the Responses Table
- Step 6. Create Indexes on Partitioned Responses Table
- Step 7. Compile Invalid Objects and Restore Database Trigger
- Step 8. Back Up the Database (can be deferred to after Step 9)
- Step 9. Regenerate Procedures and Data Extract Views
- Step 10. Back Up the Database (Optional, can be deferred to normal backup schedule)
- Partition Maintenance
- Upgrading Indexes
- Query Tuning Guidelines
- 10 Utilities
- 11 Setting Up File and Image Viewing
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12
Setting Up Replication
- Replication Concepts
- Prerequisites to Setting Up Replication
- Setting Up Replication-Related Reference Codelist Values
- Setting Up the Database Links for Standard Replication
- Creating the Study Design Replication Packages
- Setting Up Symmetric Replication
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13
Using Replication
- Example of an Oracle Clinical Distributed Study
- Operating from the Study-Owning Location
- Operating from a Sharing Location
- Enabling a Study for Replication
- Using Standard Replication
- Using Disconnected Replication
- Changing Study Ownership
- Replicated Tables
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8
Managing Batch Jobs
- A SAS_VIEW Directory Tree
- B Environment Variables and Registry Settings
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C
Troubleshooting
- Restart Application Server After Redeploying RDC Onsite
- Managing High Sequence Numbers
- Error Messages
- System Malfunction: GPF Occurs During Data Entry
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PSUB Jobs
- Check the Failure Text in the Submitted Batch Jobs Window
- Check the PSUB Log Files
- If Batch Jobs Hang and the Batch Queue Is Full
- Determining if PSUB Is Running for a Database
- Troubleshooting PSUB Based on the Batch Job's Execution Status
- Handling PSUB Failures that Return "Fatal two-task communication protocol" Error
- Handling PSUB Failure that Returns "Illegal use of PSLAUNCH…" Error
- Tracking Previous PSUB Process Connections
- PSUB Fails to Start
- PSUB Remains at Entered Status
- Troubleshooting PSUB on a Windows Database
- Database Trace
- Problems in Reports
- Error Accessing Web Services from Client
- D Routine Server Administration
- E Oracle Clinical Tablespaces
- Glossary