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CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Oracle Clinical Training Modules: Oracle Clinical Training Modules (cont.):
(please click on the following links to go to
specific modules)
• Mass Update
• Overview/Hands-on
• Discrepancy Management
• Study Design
• Freezing and Locking
• Treatments & Randomization
• Batch Data Load
• Global Library
• Labs
• Study Definition
• Administration
• Data Extract
• Replication
• Character Layout Editor
• Database Structure
• Graphic Layout Editor
• SQL Plus
• Procedures
• PL/SQL
• Advanced Procedures
• OC 4.5 Upgrade from OC 4.0.3
• Data Entry
• OC 4.5.1 Upgrade from OC 3.2
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Oracle TMS Training Modules: Oracle RDC Training Modules:
(please click on the following links to go to (please click on the following links to go to
specific modules) specific modules)
• TMS Coding • RDC User
• TMS Administration • RDC Administration
• TMS 4.5.2 Coding Upgrade • RDC 4.5.1 Upgrade
• TMS 4.5.2 Admin Upgrade
Oracle AERS Training Modules: eLoader Training Modules:
(please click on the following links to go to (please click on the following links to go to
specific modules) specific modules)
• AERS Overview/Data Entry • eLoader User
• AERS Query/Lists/Case Browse • eLoader Administration
• AERS Reports/Submissions/Special
Topics
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Overview/Hands-On [Go up]
1/4 Day – also 1/2 day & full day options
Overview
Review of Oracle Clinical Functionality
Study Set-up
Global Library
Labs
Study Definition
Procedures
Data Entry
Batch Loading
Discrepancy Management
Data Extract
Admin
Navigation
Basic Form Functions
Security
Reports
Batch Jobs
Practice searching for records, adding and deleting records, running
reports and batch jobs and getting help.
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Study Design [Go up]
½ Day
Overview
Global Study Objects (Programs, Projects, Regions, Org Units)
Easy Study Design
Intervals
Clinical Planned Events
Investigators
Sites
Study Sites
Investigator Assignments
Patient Positions
Alpha Patient Codes
Patient Enrollment – Manual/Batch
Study and Site Plans
Test Study Design
Practice creating studies, intervals/events, sites, investigators, patients,
assignment to studies/sites, patient enrollment
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Treatments and Randomization [Go up]
½ Day
Overview
Active Substances
Drugs
Single Regimens
Combined Regimens
Treatment Patterns
Assigning Regimens to Patterns
Assigning Patterns to Intervals
Randomization Overview
Strata and Factors
Creating Randomizations
Loading Randomizations
Blind Breaks
Access to Patient Assignments
Updating Patient Assignments within OC
Access Views
Security
Practice setting up Drugs, Regimens, Patterns, Loading or Creating
Randomizations
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Global Library [Go up]
½ Day
Overview
Process Flow
Domain Security
Domain Access
Object Status
Questions
Question Attributes
DVGs
Internal
Thesaurus
Alpha
DVG Subsets
Question Groups
Adding Questions to Question Groups
Standards Affiliations
Practice creating Questions, DVGs, and Question Groups from sample
CRFs
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Study Definition [Go up]
1 Day
Overview
Modeling Process
DCM Overview
Qualifying Questions
DCM Subsets
Conditional Branches
Indicator Questions
Reoccurring Questions
Repeating Question Groups
Repeating Defaults
Univariate Discrepancy Checks
Handling Dates
DCIs & DCI Log-in Attributes
Copying DCMs and DCIs
Copy Groups
Testing Objects
DCI Books
CRF Page Tracking
Scheduling DCMs
Practice creating DCMs, adding QGs and Questions, creating
subsets, adding Qualifying Questions, setting up Indicator,
Occurrences, and Conditional Branches, setting up Repeating
Question Groups, creating DCIs, using Copy Groups, scheduling
DCMs, setting up Page Tracking from sample CRFs
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Data Extract & View Builder: [Go up]
1 Day or split into ½ day classes
Data Extract Views View Builder
Overview Key Templates
View Structure Extended Attributes
Default View Creation Complex Questions
View Maintenance and Accounts Customizing Views and Templates
Current / Test Views Mapping and Link Modes
Stable / Rollsnap Views Where and Having Clauses
Snapshot views Data Quality Status Flag
DCM View Naming Conventions Study Access Account
Management
Viewing Data Extracts in SQL Plus
Cross Study / In Study Unions
NORMDATA Views
DX Installation Configuration
Extract Macros
Settings
Viewing Data On-Line
SAS Views / Datasets / Proc Print
Practice creating extracts, viewing Reports
data on-line and through SQL Plus,
and creating macros Externally Loaded Views
Practice setting up complex
questions, extended attributes,
custom templates, in-study and
cross study unions
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Character Layout Editor [Go up]
1/2 Day
Overview
Gridlines
Selecting Objects
Moving Objects
Editing Objects
Adding Text
Copying Objects
Deleting Objects
Draw Rectangles
Resize Objects
Aligning Objects
Controlling Cursor Movement
Validating Layout
Saving Layout
Adding New Objects
Practice creating and editing character layouts using practice CRF
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Graphic Layout Editor [Go up]
1 Day
Overview
DVG Fields
DCM Layouts
Selecting, Moving, Editing, Copying, Resizing, Aligning, Distributing
and Deleting Objects
Adding Text and Wrapping Text
Adding an Image
Drawing Tools
Controlling Cursor Movement
Flex Fields
Validating and Saving Layout
Adding New Objects
Freezing and Unfreezing Objects
Print PDF form or Annotated PDF
DCI Layouts
Controlling DCM Header Fields
DCI Form Templates
Creating and editing Headers and Footers
Configuration Settings
Practice creating and editing DCM layouts, DCI layouts, and DCI
Form Templates using practice CRF
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Validation and Derivation Procedures [Go up]
1 Day
Overview
Creating and generating procedures
Testing and Activation
Versioning
Details
Dynamic Messages
Variable Controls
Correlation
Visit Restriction
Qualifying Expressions
Where Clause Extensions
Aggregate Variables
Lag Variables, Aggregate Lags
Placeholders
Thesaurus/Lab Range Variables
User Variables
Custom Code
Calling Packaged Procedures
Procedure Variables and Variable Details
Practice writing procedures with multiple DCMs, correlation,
placeholders, Where Clauses, Aggregates, Lags, User Variables, and
Custom Code
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Advanced Procedures [Go up]
1 Day
Overview
Procedure Internals
Compiled procedure line by line
Correlation
Qualifying Expressions vs Where Clause Extensions
Aggregate Variables
Lag Variables, Aggregate Lags
Placeholder
User Variables
Custom Code – Use of different types
Calling Packaged Procedures
Procedure Variables and Variable Details
Advanced Procedure Samples
Cross DCM Check – Reason = ‘X’ then Y exists on other Form
Verify that for a Visit there are not multiple dates
Check that there are no duplicates in a DCM (e.g. AEs with same
start date and dose)
Check for non-consecutive dosing dates and times
Writing procedures against DX Views
Performance Considerations
Practice writing more advanced procedures with multiple DCMs,
correlation, placeholders, Where Clauses, Aggregates, Lags, User
Variables, Custom Code, and special examples
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Data Entry: [Go up]
1 Day for DE Operators / 1/2 Day for Data Managers
Overview
Use of Toolbar Functions
Initial Log-In Fields
Initial Log-in and Entry
First Pass Entry
Univariate Validation
Operator Comments
Investigator Comments
Second Pass Entry
Comparison Reconciliation
Sight Verification
Browse
Update
Key Changes
Privileged Update
Deleting RDCIs
DCI Books/Page Tracking
Audit Trail
Configuration Settings & Preferences
Practice entering data, performing second pass, updates, and key
changes
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Mass Update: [Go up]
1/2 Day
Overview
Mass Specification Records
Candidate Data Sets
Validating and Transferring Data
Group Updates
Audit Trail
Practice set up mass updates, change responses and keys
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Discrepancy Management/DCFs: [Go up]
1 Day (usually given with Freezing and Locking)
Overview
Discrepancy Generation
Types of Discrepancies (Univariate, Manual, Manual Header,
Indicator, Multivariate)
Manual Resolution
Data Updates
Review Status
Resolution Status
System Status
Review and Internal Comments
Flex Fields
Discrepancy History
User Profiles
Standard Text
Multi-view mode and Group Select Functions
Custom Layouts
DCF Creation
DCF Management & History
DCF Printing
Practice reviewing discrepancies in Data Entry and Discrepancy
Management, resolve discrepancies manually and by data
changes, generate and print DCFs, use Standard Texts
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Freezing and Locking: [Go up]
1 hour (usually given with Discrepancy Management)
Overview
Locking - Batch and On-Line
Freezing & Unfreezing – Study and by level
Updates to Locked Data
Practice locking and freezing at different levels
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Batch Data Load: [Go up]
½ Day
Overview
User-Specified Formats
The File Structure
Setting up Loads
Load Stage
Prepare Stage
Prepare to Completion
Transfer Stage
Deleting Loaded Files
Identifying Batch Loaded Data
Combining Batch Jobs
Debugging Failures
Privileged Transfer
Normalized Lab Data Loads
Loading Test Data
Practice setting up Formats, running and debugging different loads
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Lab System [Go up]
1/2 Day (including NORMLAB2 Plus Set-up)
Overview
Lab Units
Lab Test Questions
Conversion Units
Labs
Lab Ranges
Subsets
Electronic Load of Ranges
Normalized Data Loading
Preferred Copy Groups
Textbook Ranges
NORMLAB2 Plus Set up
NORMLAB2 Plus Derivation Procedure
NORMLAB2 Plus Extract
Lab Assignment Criteria
Pre and Post Assignment of Ranges
Lab Re-Execution Procedure
Practice settings up labs, creating lab questions, creating units,
assigning units to questions, setting up lab and textbook ranges,
creating and applying LAC, setting up NORMLAB2 Plus, generating
NORMLAB2 Plus extracts
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Administration: [Go up]
1/2 Day - Administration & Replication
Overview
Menu Set-up
User Menu Access
Study Access/Super Users
Domain Access – User/Study
Account Management
DE Configuration Settings
DE Preferences
Log-in Layout Editor
DX Configuration Settings
Graphic Layout Configuration Settings
Batch Loading Issues
Data Extract Issues
Reference Codelists
PSUB
Job Scheduling
Web Server
Report Server
Practice assigning global library domain access, study access,
creating an account, creating and scheduling a job set
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Replication: [Go up]
1/2 Day – Replication and Administration
Overview
Glib Replication
Symmetric Replication
Distributed Study Management
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Database Structure: [Go up]
1/2 Day – Database Structure
Overview
OC Database Overview – Walkthrough of database relationships
Practice selecting practical data from audit trail tables, global library
tables, study design tables, study definition tables, procedures tables,
data entry tables, discrepancy management tables, data extract
tables, and labs tables
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
SQL Plus: [Go up]
1 Day
Overview
Tables and Table Relationships
Describe Command
Select Command
Where, Order By, Group By, Having, and Union Clauses
Editing Commands
Spooling Output
Formatting Output
Combining Tables
Outer Joins
Subqueries
Identifying Tables and Views
More Advanced Commands
Null Values
Arithmetic Expressions & Functions
Character Functions
Date Functions
Practice querying extracted data, using Where Clause and Order by
Clause, editing commands, formatting outputs, combining tables
using subqueries and outer joins, using Having, Union, Intersect and
Minus Clauses, practicing advanced commands
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
PL/SQL: [Go up]
1 Day
Overview
Variables
Assigning Values to Variables
Records – Table-Based and Cursor-Based
Programmed-Defined Records
Cursors
Control Structures (IF, IF-THEN, IF-THEN-ELSE, IF-THEN-ELSIF, LOOP,
WHILE…LOOP, FOR…LOOP, EXIT, EXIT..WHEN Statements)
Commit and Rollback
Exceptions and Unhandled Exceptions
Subprograms
Procedures, Functions and Packages
VARRAY
Dynamic SQL
Best Practices
Practice declaring variables, troubleshooting code, declaring
cursors, using Control Structures in statements, using exception
statements, writing procedures, writing functions, writing statement
that creates and initializes a VARRAY,
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
OC 4.5.1 Upgrade: [Go up]
1 Day (from OC 4.0.3)
Overview of OC upgrade features
Miscellaneous Changes
Audit Trail upgrades
Overview RDC upgrade features
Overview TMS upgrade features
Graphic Layout Editor
Features
Practice creating and editing DCM layouts, DCI layouts and DCI
Form Templates using practice CRF
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
OC 4.5.1 Upgrade: [Go up]
3 Days (from OC 3.2)
Overview of all New Features
Alpha DVGs
Practice creating and using Alpha DVG
Character Layout Editor
Features
Practice editing a DCM character layout using practice CRF
Enhanced Discrepancy Management System (EDMS)
Profiles
Standard Texts
New Screen Features
DCF Creation, Management and Printing
Practice using Standard Text, reviewing/resolving Discrepancies,
creating, managing, and printing DCFs
Mass Update
Mass Specification Records
Candidate Data Sets
Validating and Transferring Data
Practice setting up candidate sets, updating responses and keys
Graphic Layout Editor
Features
Practice creating and editing DCM layouts, DCI layouts and DCI
Form Templates using practice CRF
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
TMS (Thesaurus Management System) for Coders [Go up]
1 Day
Overview of TMS
How Coding Works
Sample Process – or customized for client
Dictionary and Domain basics
Omission Management and Classification
Omissions in OC Data Entry and Discrepancy Mgmt
Creating and applying Actions
Search Techniques
Omission Reclassification & Declassification
VTA Approval
High Level Reclassification
Promote/Demote VTAs
Browsing Repository and Classification data in TMS
HTML Browser
Informative Notes
Practice classifying, applying actions, using search objects,
reclassifying, approving terms, high level reclassification, resolving high
level omissions, using HTML Browser. Classification practice is done in
MedDRA and high level reclassification in WHODrug.
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
TMS for Administrators [Go up]
1 Day
Overview of TMS
How Coding Works
User and Profile Creation
Dictionary Set-up and loading basics
Dictionary Maintenance (Adding, Deleting, Modifying Terms)
Dictionary Links
Named Relations
Virtual Dictionaries
TMS Domains
OC Data Collection Set-up & Question Sets
Controlling TMS portion of OC Batch Validaton
Deriving Data from Two Dictionaries
External System Integration
Search Object Set up and Use
Global Action Set up and Use
HTML Browser
Document Repository
Informative Notes
TMS Codelist Values
Disconnected System Integration
API Summary
Database Structure
Practice creating users and profiles, setting up dictionaries, creating
domains and assigning studies, adding/deleting terms, setting up
external views, setting up and using search objects, classify, reclassify,
approve, high level reclassification, resolving high level omissions,
using Web Browser
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
TMS 4.5.2 Upgrade for Coders: [Go up]
1/2 Day (upgrade from 4.0.6)
Overview of upgrade features
HTML Browser enhancements
Improved filter and query options
Classification enhancements and bug fixes
Enhanced Action features
Expanded Copy Domain functionality
Default approved status for Terms and VTAs
Enhanced Informative Notes features
New Classification Reports
Force Rederivation of TMS questions by study
Password management
New Reference Codelist items
Practice using HTML Browser, using workflow Informative Notes in
Classification, Reclassification and Approval screens, applying actions
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
TMS 4.5.2 Upgrade for Administrators [Go up]
1/2 Day (upgrade from TMS 4.0.6)
Overview of TMS upgrade features
User creation and profile management
HTML Browser enhancements
Materialized View enhancements
New Reference Codelist items
Expanded Copy Domain functionality
Force Rederivation of TMS questions by study
Enhanced Informative Notes features
Enhanced definition of External Systems
New Classification Reports
Improved filter and query options
Enhanced Action features
Password Management
Disconnected System Integration
Practice creating user and user profiles, creating dictionary version
Informative Notes, and executing a Force Rederivation of TMS
questions
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Remote Data Capture: [Go up]
1 day for Internal Users or 1/2 day for Site Staff
Overview
Navigation
Selection Window
Activity List
Searches and Saving Searches
PDF and/or Classic Data Entry
Adding Patients
Entering/Updating/Deleting Data
Univariate and Manual Discrepancies
Adding Unplanned Pages
Adding Unplanned Visits
Data Entry Audit Trail
Validating Data
Reviewing and Resolving discrepancies
Discrepancy History
Data Verification/Unverification
Data Approval/Unapproval
Group Activities
Locking and Unlocking
Practice selecting CRFs, adding patients, entering and updating
data, creating and resolving discrepancies, validating data, verifying
data, approving data
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
Remote Data Capture Administration: [Go up]
1/2 day
Overview
Study/Site Security
Administering RDC
RDC News
RDC Links
RDC Configurations and Preferences
Practice setting up user access, creating News items and creating
Links.
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
RDC 4.5.1 Upgrade: [Go up]
1/2 day (upgrade from 4.0.3)
Overview of new features
Activity List
PDF Data Entry
PDF Discrepancy Management
Internal Discrepancies
PDF Data Verification/Unverification
PDF Data Approval/Unapproval
Group Activities
Locking and Unlocking
RDC Configuration
Practice entering and updating data, creating and resolving
discrepancies, validating data, verifying data, and approving data in
PDF mode, using Group Activities
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
AERS User Training - Overview/Data Entry [Go up]
1 Day with either Clinical Trial or Spontaneous Practice
Overview
Introduction to AERS
Summary of Features
AERS Active Workflow
Login and Logout
Window Features
Subsystems
Passwords
Data Types and Data Entry
Help
Data Entry
Working with Data Entry Forms
1. Navigation and data entry features
2. Menus and Toolbars
Data Entry Windows
1. Screen Regions
2. Navigation
Active Workflow Case Study (Spontaneous or Clinical AE Case)
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
AERS User Training – Query, Lists and Case Browse [Go up]
1 Day
Queries
Query Subsystem
Managing Queries
Specifying Query Criteria
Literals, Wildcards and Dates
Positive and Negative matches
Relational, logical and combining expressions
Advanced Querying
Dictionary fields
Parameters
Missing records
Conditions, Components and combining Conditions and
Components
Lists
Types of Lists
Managing Lists
Query with Lists
Case List Detail Report
Case Browse
Case Browse Window
Working with Cases
Working with Folders and Items
Working with Queries and Case Lists.
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
AERS User Training – Reports, Submissions, Special Topics [Go up]
1 Day
Reports
Overview
Types of Reports
Reports Subsystem
Running, Viewing, Saving, Printing, Mailing Reports
Report Parameters
Periodic Reports and Saved Queries
Quick Reports
Submission Tracking
Overview
Creating Reportability Records
Running Reports for Submissions
Submission Tracking Records
Follow-up Reports
Updating Submission Dates via Case Lists
E2B Reports, Acknowledgements and Nullifications
Special Topics
Managing Discrepancies
Cases not Involving Adverse Events
Generating Letters
Attaching Documents to Cases
Home Page Portal
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
eLoader User: [Go up]
1 Day
Overview
Creating a conversion
Identifying data to convert
Creating formats
Identifying datasets for file import
Identifying tables as datasets
Importing data from file
File Compare Utility
Conversion Rules
Mapping Keys and Responses for OC data
Mapping Keys and Responses for design data
Copying Metadata
Creating conversion run
File and Batch Load Options
Prepare, Validate and Generate Processes
Deleting data in OC
Reports
Practice setting up file formats, conversions, and mappings, loading
from files into OC, deleting data in OC, loading patients into OC,
setting up scanning and autoloading, comparing and splitting files
CSS Informatics Training Modules
Oracle Life Sciences - OC, TMS, RDC & AERS 4.5
eLoader Administration: [Go up]
1 Day
Overview
Creating and maintaining users
eLoader Alerts
Control Settings and Options
Setting up eLoader directories
Scan Process and scanning rules
Import Process
AutoLoad
File Compare Utility
Prepare Process
Conversion runs
Validate checks
Generate and load data into OC
Batch Jobs and Scheduling
Log Screens
Reports
Practice setting up automation, comparing and splitting files, setting
up file formats, conversions, and mappings, loading from files into
OC, deleting data in OC
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