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Oracle Clinical Overview/Hands-On

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Oracle Clinical is a comprehensive Clinical Data Management system developed by the Oracle Corporation

It is based on the Oracle 7 Relational Database and Oracle’s Developer 2000 front-end tools

Version 3.1 production released in April 1998; Version 3.1.1 released in November 1998

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Oracle Clinical OverviewKey Functions

Oracle Clinical

Admin

Global Library

Study DesignCRF

Modeling

Procedures

Data Entry Batch Load

Discrepancy Mgmt

Data Extract Labs

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Oracle Clinical OverviewWhat Can I Do in Oracle

Clinical? Administration

Create users, assign access, set up codelists Set-up a Study

Assign sites, investigators, patients, events, treatment patterns and regimens

Load or create treatment randomizations Build the Global Library

Create questions, question groups, discrete value groups, extract macros, extract templates

Organize objects into different domains

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Oracle Clinical OverviewWhat Can I Do in Oracle

Clinical? Model CRFs for a Study

Create the Data Collection Modules (DCMs) and Data Collection Instruments (DCIs)

Modify the attributes of the DCMs/DCIs to perform univariate checks and to appear as CRFs

Set up Validation Procedures to perform edit checks across questions/visits

Set up Derivation Procedures to calculate derived questions

Set up Labs, Units and Ranges

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Oracle Clinical OverviewWhat Can I Do 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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Global Set-up

Codelists

Users

Labs & RangesGlobal Library

Study/Domain Access

Study Set-up

Design

CRF Modeling

Procedures

Views

Treatments Randomization

Study Conduct

Data Entry

Batch Data Load

Extract Data

Discrepancy ManagementDatabase Locking

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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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Pre-Study Set-up, global study categorizations

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.

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Set up Clinical Studies

These modules are used to set up (or design) new studies. this includes identification of the study, patients, visits, sites, and treatment patterns.

Typically a common set of these objects is maintained across sites (Symmetric Replication can be used).

This module also is used to create, load, and manage randomization information.

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Oracle Clinical OverviewClinical Study Set-up

Programs(Compounds)

Project(Indication)

Project(Indication)

Study Study

Sites PatientsEvents

Investigator

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Hands-On