oracle clinical overview_katalyst hls

Oracle Clinical Overview

05/03/2023

Katalyst Healthcares & Life Sciences

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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

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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

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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)

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Oracle Clinical Overview System Administration

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System Administrative Functions

These modules provide an interface for managing users, security, replication, and customization. Typically controlled by a System Administrator or Global Librarian.

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Oracle Clinical Overview Pre-Study Set-up23

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

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Oracle Clinical Overview Study Design24

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

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Oracle Clinical Overview Global Library25

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

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Oracle Clinical Overview Study Definition26

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

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Oracle Clinical Overview Data Entry

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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

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Oracle Clinical Overview Study Conduct

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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.

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Oracle Clinical Overview Batch Data Load29

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.

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Oracle Clinical Overview Discrepancy Management30

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

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Oracle Clinical Overview Data Extract31

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

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Oracle Clinical Overview Mass Changes32

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).

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Oracle Clinical Overview Freezing and Locking33

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.

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Oracle Clinical Overview Lab System34

Lab System

These modules are used to identify labs where tests are conducted, set up lab ranges, and assign labs to actual CRFs (DCIs).

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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

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Thank You&

Questions

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36Contact:Katalyst Healthcare’s & Life SciencesSouth Plainfield, NJ, USA 07080.E-Mail: [email protected]

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