Oracle Clinical Overview_Katalyst HLS

Oracle Clinical Overview
2/21/2017Katalyst Healthcares & Life Sciences

2
Agenda
 This section will cover the following topics:
 What is Oracle Clinical?
 Global Library
 Data Collection Definitions
 Generating Data Entry Screens
 Data Capture
 Data Validation Definition
 Data Derivation
 Validation Procedure execution and Reporting
 Query Management
 Data Extracts
 Laboratory Reference Range Management
 Thesaurus Management System
 System Management
 Subsystems
 Key Functions in Oracle Clinical?
 Questions

3
What is Oracle Clinical?
 A software package sold and supported by Oracle Corporation
 A system which supports all aspects of Clinical Data Management
 Global Pharmaceutical, Biotechnology, and Medical Device Companies
 Contract Research Organizations

4
What is Oracle Clinical? Contd..
 Key Functions Supported
 Define and Manage a Clinical Study (Protocol)
 Define treatment patterns for randomization
 Define data elements to be collected in a study
 Define and generate data entry screens
 Collect and manage the data
 Define edit checks to be applied to the data
 Manage and resolve the results of the edit checks
 Extract data for analysis
 Manage lab data against reference ranges
 Code investigator terms against medical thesauri
 Remote Data Capture
 Distributed study conduct (Replication)
2/21/2017
Katalyst Healthcares & Life Sciences

5
Global Library:
 Company-wide Library of Data Elements for use as building blocks for study Data
Definitions
 Discrete Value Groups (DVGS)
 Questions (Qs)
 Question Groups (QGs)
 Data collection Modules (DCMS)
 Data Collection Modules (DCIs)
 Validation and Derivation Procedures
 Extract View Definitions
2/21/2017

6
Data Collection Definitions:
 Case report Forms are modeled as Data Collection Modules (DCMs)
 DCMs for a study are built using objects from the Global Library or from DCMs
copied from other studies
 Questions and Question Groups from the GLIB
 DCMs from the GLIB or from other studies
 Study Level DCMs are modified before use to adjust for specific study conditions

7
Generating Data Entry Screens:
 User specifies default prompt for each question in the DCM
 Default Layout is generated
 User may edit generated layout using the Layout Editor
 Final screens used for data entry, update and browse
 Screens are marked as “Active” when ready for Production entry

8
Data Capture:
 Each patient's enrollment data (DOB, Sex, Initials) is keyed to the system
(Optional)
 Each CRF Page is logged to the system
 Pass 1 Data Entry is performed
 Pass 2 Entry is performed ( Can be made Optional)

9
Remote Data Capture (RDC):
 Investigator Friendly interface for entering and maintaining Clinical data from a
remote Investigator site
 Click and enter data for a module through a spreadsheet entry format
 Execute multivariate checks on demand
 Separate verification/approval status
 Site base security

10
Data Capture – Batch Load:
 Data captured electronically may be loaded rather than entered
 Input file must be defined in a standard load format
 Data load supports insert of new data and update of existing data
 Examples of Batch Loader - eLoader

11
Data Validation Definition:
 Single-field checks are done automatically during data entry or batch load
 Inter-field checks are defined in Validation Procedures
 Validation Procedures are coded as Boolean expressions
 Validation Procedures may be run against test data in test mode before
Production release

12
Data Validation Definition Contd..
 Procedures can compare different fields on the same CRF for the same visit
 Procedures can compare fields from different CRFs at the same visit
 Procedures can compare same fields from CRFs at different visits
 Procedures can compare responses from different CRSs at different visits

13
Data Derivation:
 Derived questions may be added to a DCM
 Derivation procedures define how the value is calculated and executed in batch
 Eg: Age is a derived question ie. The value is derived from the Date of Birth and
Current System Date.
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14
Validation Procedure execution and Reporting:
 Validation failures are entered in Discrepancy Database
 Discrepancies are tracked, managed and resolved online
 Closed discrepancies may be marked as “resolved” or “irresolvable” or “obsolete”
 Data Quality reports can show historical Discrepancy rates

15
Query Management:
 Discrepancies from single field failures inserted into Discrepancy Database
 Discrepancies from multi-field failures detected during a batch validation also
inserted into Discrepancy Database
 Updates to data can be made as Investigator resolves the Queries
 Data may be locked or frozen when considered clean

16
Data Extracts:
 System creates a set of CRF-based views for each study
 CURRENT view is view of the working data
 STABLE view is view of the data at the of the last last batch validation
 SNAPSHOT view is view of the data at some previous point in time
 Test view is view of the data entered in Test Mode
 Views may be accessed from Oracle or any third-party tool
 Equivalent set of SAS views created for accessing data from SAS.
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17
Laboratory Reference Range Management:
 Allows definition of Normal Ranges for Laboratory Data
 For each lab store valid range and units for each lab test
 Range may vary by age and gender of patient
 Range may vary over time
 Lab range subsets allow range to vary by patient category, for example, diabetic
patient
 CRFs are mapped to laboratory that produced results
 Ranges and units are available to validations and extractions
 To flag, out of range values and for unit conversions
2/21/2017

18
Thesaurus Management System:
 Dictionaries are loaded into Thesaurus Management System
 DCMs are defined with derived questions to hold the dictionary terms and codes
 Manual Classifications allows search against dictionaries

19
System Management:
 Allows company specific definition of master code lists
 For example, which question categories will be available
 Allows company specific security management,
 which user can see which menu options
 which user can access which studies
 Allows company specific installation information
 Machine name and printer name
 Allows definition of company specific programs and reports

20
Subsystems:
 Study Design
 Global Library Management
 Data Collection Definition
 Data Capture
 Data validation Definition
 Data Validation Execution And Reporting
 Data Extracts
 Lab Reference Management
 Thesaurus Management
 System Management

21
Key Functions in Oracle Clinical?
 Enter Data
 Manually via Data Entry or electronically through the Batch Data Load facility
 Extract Data
 Create standard views of data in Oracle and SAS
 Define custom views within a study and across studies
 Manage Discrepancies
 Review and resolve discrepancies; update data
 Create Data Clarification Forms for Site review
 Freeze and Lock Data
2/21/2017

Oracle Clinical Overview System Administration
22© 2008, Cognizant Technology Solutions.
System
Administrative
Functions
These modules provide an
interface for managing users,
security, replication, and
customization.
Typically controlled by a
System Administrator or Global
Librarian.

Oracle Clinical Overview Pre-Study Set-up
23
These modules are used to set up Global
Objects that are used in categorizing
studies. Typically a common set is
maintained across sites.
These values are usually maintained by an
Administrator and must be in place
before a study can be defined.
Pre-Study Set-up

Oracle Clinical Overview Study Design
24
These modules are used to set up (or design)
new studies. This includes identification of
the protocol, patients, visits, sites, and
investigators.
This module can also be used to create, load
and manage randomization information.
Studies can be replicated between locations
for distributed management and shared data
access.
Clinical Studies

Oracle Clinical Overview Global Library
25
These modules are used to create and manage
Global Library Objects.
The Global Library serves as a central
storehouse of objects that are used for
modeling CRFs (Questions, Question Groups,
and DVGs) as well as to create CRFs
(DCMs/DCIs), Procedures and Extract View
Definitions.
The Global Library allows a company to
maintain standards, but allows flexibility when
the objects are used in studies.
Companies can replicate the Global Library
between locations.
Global Library

Oracle Clinical Overview Study Definition
26
These modules are used to model CRFs, set up
Page Tracking, set up edit checks, set up
derived value calculations, and define custom
extract views.
Test Data Entry, Test Procedure Execution,
Test Discrepancy Management, and Test Mass
Changes is also conducted from this menu.
CRF Modeling and Definition

Oracle Clinical Overview Data Entry
27
These modules are used to
manually enter update, and
browse data by the Data
Management Group.
First and Second Pass
Data Entry, and an optional
Reconciliation stage are
available.
Data Entry

Oracle Clinical Overview Study Conduct
28
Study Conduct These modules are used to manage
the on-going study by the Data
Management Group.
This includes generation and control
of Extract Views, Batch Loading of
Data, Management of Discrepancies,
Mass Changes and Database Locking.

Oracle Clinical Overview Batch Data Load
29
Batch Data Load
The Batch Data Load Modules
provide a way to electronically
load data.
Two modes (In Study for within
study single DCM loads) and Out
of Study (for multiple study
multiple DCM loads) are available.

Oracle Clinical Overview Discrepancy Management
30
Data Validation
The Discrepancy Management System allows
identification of single question (univariate)
discrepancies, multiple (multivariate)
discrepancies, manual comments, and
Thesaurus discrepancies.
The system automatically creates
discrepancies during Data Entry or Batch
Processing.
DM/CRAs can review discrepancies, update
their status, modify data, and create DCF
reports to send to Investigators

Oracle Clinical Overview Data Extract
31
The Data Extract Module provides the
capability to automatically generate and
modify extract views for both Oracle and
SAS.
Different types of views (current, snapshot,
etc.) can be created.
Different keys, responses, and data about
the responses can be included in the views.
Data Extract
2/21/2017

Oracle Clinical Overview Mass Changes
32
Mass Changes
The Mass Changes Utility provides a way
to change data for up to 99,999 records
at a time.
Keys and responses can be changed, and
RDCIs can be deleted (soft delete).

Oracle Clinical Overview Freezing and Locking
33
Freezing & Locking
The Freezing and Locking Modules
provide a way to close a study.
Locking prevents changes to existing
records. Freezing prevents changes to
existing records and prevents addition
of new records.
Freezing and Locking can be done on a
record by record or on a group basis.

Oracle Clinical Overview Lab System
34
Lab System
These modules are used to
identify labs where tests
are conducted, set up lab
ranges, and assign labs to
actual CRFs (DCIs).
2/21/2017

35
Questions
 Oracle Clinical is a system which supports all aspects of Clinical Data Management.
[true/false] ans – True
 Which of the following is part of OC:
 Data Validation Definition
 Validation Procedure execution and Reporting
 Query Management
 All of these [answer]
 Data can be entered only electronically through the Batch Data Load facility [true/false]
ans – false

Thank You
&
Questions
2/21/2017
36Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com

Oracle Clinical Overview_Katalyst HLS

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