3 Configuring Discrepancy Management Mapping Database Roles to User Roles
Specifying User Roles for the
Oracle Clinical Discrepancy Database
Assigning Function Privileges and Layouts
Customizing Layout Definitions
Customizing
Profiles
Toggling Between View Modes in the Profile Administration Window
Specifying Default Profile Criteria
Locking Profile Criteria
Adding SQL Statements
Filtering Profile Views by Review Status
Updating Status Codes
Filtering Profile Views by Discrepancy Field
Customizing Flexfields
DISC_FLEX1 and DISC_FLEX2
DISC_FLEX1_VALUES and
DISC_FLEX2_VALUES
Example
Defining Reason Codes for
v Reason Codes and Descriptions for Manual Discrepancies
Reason Codes and Descriptions for Univariate Discrepancies
Reason Codes and Descriptions for Multivariate Discrepancies
Defining the Possible Review Statuses for Discrepancies
Default Entries for the DISCREPANCY REV STATUS CODE Codelist
Rules for the DISCREPANCY REV STATUS CODE Codelist
Defining Resolution Reasons for Discrepancies
Setting Values
in the OCL_STATE Local Reference Codelist
Configuring Role-Specific Discrepancy Management for RDC
Configuring Discrepancy
Display by User Role
Configuring the Actions Allowed on Discrepancies
Preventing Update to OTHER Discrepancies
Adding Reference Codelists for Custom Roles
Configuring Study and Site Security for Discrepancy Management
Updating a
Discrepancy
Navigating to Data Entry vi Default Behavior
Functions Used to Modify CRF Column Headers
Functions
Customizing Online Help
Modifying Calls to Online
Help Topic Files
Copying Xhelp Topic Files
Creating Custom Help Files
Viewing Xhelp Without Oracle
Clinical
6 Configuring Data Extract Configuring Default Installation Data Extract Settings
Setting Values
in Data Extract-Related Reference Codelists
Creating Table spaces for Data Extract Tables and Indexes
Creating Table spaces
Entering Tablespace Names in Reference Codelists
Creating Data Extract Access Accounts Using Local Table spaces
Customizing
Data Extract Views
Generating Data Extract Views
Running gen_views on UNIX Platforms
Running gen_views on Windows
Enabling the View Builder and Converting Views
Converting Views
Enabling the View Builder in a Study
Controlling
Access to Data Extract Views
7 Reference Codelists Overview of Reference Codelists
Working in the Maintain or Query Reference Codelists Windows
Adding a Value to a Reference Codelist
Modifying a Value in a Reference Codelist
Running the Reference Codelists Report
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
vii 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
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
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
viii 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
ix Design Installation Reference Codelists
System Reference
Codelists
Part II Oracle Clinical Administration Tasks
8 Managing Batch Jobs User Account Requirements for Batch Jobs
How PSUB Handles a Request
Asynchronous PSUB Requests
Blocking and Nonblocking Jobs
Checking a Nonblocking Batch Job
Starting and Stopping PSUB
Starting and
Stopping PSUB Manually in UNIX
Starting and Stopping PSUB Automatically in UNIX
Starting and Stopping PSUB Manually in
Windows
Starting PSUB Automatically in Windows
Managing the PSUB Process
Changing PSUB Job Number Sequencing
Viewing
the Status of a Submitted Batch Job
Removing the PSUB Service
Viewing Log and Output Files on the Screen
Using Job
Sets to Control Execution Order
Tracking PSUB Processes
Batch Job Reference Codelists
9 Partitioning and Indexing Introduction
Timing Considerations and Deferral of Index or Partition Upgrade
About Partitioning
Planning for Partitioning Upgrade
Pre-upgrade Steps
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
Step 9 Regenerate Procedures and Data Extract Views
Step 10
Back Up the Database
Partition Maintenance
Upgrading Indexes
Index Upgrade Process
Resizing the Storage
Clause for Indexes
x Response Index Upgrade
ResponsesT (Test Database) Index Upgrade
RECEIVED_DCI and RECEIVED_DCM
Index Upgrades
Query Tuning Guidelines
10 Utilities Computing the Validation Status of All Responses
Running cnvstatus on UNIX 10-1 Running cnvstatus on Windows10-2 Generating Validation Procedures 10-2 Running gen_procs on UNIX
Systems 10-3 Running gen_procs on Windows Systems 10-3 Deleting Inactive Procedures
11 Setting Up File Viewing Overview of the Process to Set Up File Viewing
Changing the Default Protocol for File Viewing
Editing formswebcfg to
Specify the File Viewing Protocol
Setting the Oracle Entries in the System Registry for SFTP or FTP
Setting Up the
Directory Mappings for HTTPS and HTTP
Setting Up Image Viewing for DCI and DCM Form Layouts html Preview
12 Enabling Image Viewing Setting Up a Central Image Repository
Setting Up a Network User to Run the Oracle
Process Manager Service
Setting Up Image Viewing During Data Entry
Copying Image Files to All Installations
13 Conducting Studies in a Distributed Environment Distributed Study Environments and Replication
Locations in a
Distributed Study Environment Installation
What Types of Oracle Clinical Objects Can You Replicate?
What Methods of
Replication Does Oracle Clinical Support?
Prerequisites to Setting Up Replication
Oracle Accounts for Replication
Tables that Store Replication Information
Seed Numbers for Databases Involved in Replication
Setting Up Replication
Configuring the SOURCE LOCATION CODE Installation Codelist for Replication
Configuring the OCL_INSTALLATION Installation Reference
Codelist for Replication
Configuring the OCL_STATE Local Reference Codelist for Replication
Creating and Setting
Up the Database Links for Standard Replication
Creating the Study Design Replication Packages
Using the rxasrallsql Script
Creating the Views and Synonyms Required to Replicate Study Design
Creating the Package for Replicating Investigators and
Sites
xi Setting Up Symmetric Replication
Setting Up Symmetric Replication
Enabling Symmetric Replication
Reconciling Data
Trouble shooting Symmetric Replication
14 Using Replication Example of an Oracle Clinical Distributed Study
Operating from the Study-Owning Location
Changing Ownership and Replicating Patient Positions
Maintaining Investigators and Sites
Constraints at the Study-Owning Location
Replicating Data at a Study-Owning Location
Operating from a Sharing Location
Study Design at a Sharing Location
Study Definition at a Sharing Location
Study
Conduct at a Study-Sharing Location
Data Replication at a Study-Sharing Location
Replication of Labs and Lab Ranges at a
Sharing Location
Error if Flexible Study Setting Mismatch Between Locations
Enabling a Study for Replication
Using
Standard Replication
Review of Setting Up Standard Replication
Replicating a Global Library
Replicating Study
Designs
Replicating a Study Definition
Replicating Data
Replicating Lab Information
Replication and Frequency
Using Disconnected Replication
Overview of Disconnected Replication
Review of Setting Up Disconnected Replication
Extracting Source Data to an Export File
Defining the Extract Data Parameters
Loading Data from the Export File
into a Target Location
Changing Study Ownership
Replicated Tables
III Appendixes A Environment Variables and Registry Settings Summary of the Oracle Clinical Setup
Editing opa_
settingsbat
Setting Up UNIX Environments
Changing Configuration Settings on UNIX Database Servers
Changing Environment
Variables on Windows
xii Settings that Affect Back-End Job Execution
Windows Registry Settings
OPA Front End
Online Help
Oracle Clinical Front End
RDC Front End
RDC Plugin
OCN Front End
Reports Server
Registry
Keys
Variables
B SAS_VIEW Directory Tree C Trouble shooting Managing High Sequence Numbers
Assessing Sequence Sizes
Reseeding Sequences
Error Messages
Message: Not Using Named Package
Message: OR
Message: OR
020
Message: Unable to Change Mode
System Malfunction: GPF Occurs During Data Entry
Situation: $ulimit unlimited
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
0 Trouble shooting 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
If PSUB Fails to Start
Database Trace
D Routine Server Administration Recreating Symbolic Links—UNIX Only