Use Cases for using the Program Type View

September, 2013
Mike Grossman
Vice President of Clinical Data Warehousing and Analytics BioPharm Systems

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Welcome & Introductions

Mike Grossman Vice President of Clinical Data Warehousing and Analytics BioPharm Systems, Inc. CDW/CDA practice lead since 2010
Expertise in managing data for all phases and styles of clinical trials Leads the team that implements, supports, enhances, and integrates Oracles LSH and other data warehousing and analytic solutions

Extensive Oracle Life Sciences Hub (LSH) experience

10 years of experience designing and developing Oracle Life Sciences Hub at Oracle 27 years in the industry 5+ years of experiencing implementing LSH at client sites
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Agenda
What is a view program Use case 1 Data pooling Use case 2 Data security Use case 3 Data blinding

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What is a view program?

An LSH program that has the VIEW technology type Allows you to combine data from multiple LSH table instances without storing the data multiple times Creates a user-defined view of data across multiple table instances

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View Program

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View Program Type

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Table Descriptors
Multiple LSH data sources A single target table

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Source Code

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Source Code SELECT [ hint ] [ { { DISTINCT | UNIQUE } | ALL } ] select_list FROM table_reference [, table_reference ]. . . [ where_clause ] [ hierarchical_query_clause ] [ group_by_clause ] [ HAVING condition ] [ model_clause ] [ { UNION [ ALL ] | INTERSECT | MINUS } ( subquery ) ] [ order_by_clause ]
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Source Code
Can only reference the programs source table descriptors Can call functions/procedures which are included in PL/SQL programs that are included as static references Cannot reference public database objects

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View Table

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View Table
The view table is created
When the view program is installed As a database view

Can be used as a source table for other LSH programs, data marts, or business areas The currency timestamp is applied every time you access the views current data If you remove the view program instance the corresponding table instance is also removed

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Data Currency

View Data

From source DM

From source AE

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Use Case 1 Data Pooling

The key to data pooling is having data that is standard, or conformed
SDTM or SDTM+ Company standards

Data can be pooled by

Indication Therapeutic area Compound or device Etc.

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Use Case 1 Data Pooling

Pooled data can be used for
On-going safety review Efficacy analysis To present the data to the sponsor in business area visualizations Etc.

Data pooling can be

Manual Automated

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Use Case 1 Data Pooling

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Manual Pooling
Create the view program Add multiple table descriptors Launch the IDE to create and verify the source code Install the program Manually update the program
When the source metadata changes To maintain the list of studies to be pooled

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Automated Pooling
Create and validate the pooling automation program Maintain the list of studies to be pooled

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Automated Pooling

Tables to support the list of studies to be pooled, metadata verification, etc.

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Automated Pooling

Primary source code and shared PL/SQL utilities

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Automated Pooling

PL/SQL source code

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Automated Pooling

Stores a list of LSH studies to include in the automated pooling

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Automated Pooling
The results in LSH

View programs

View tables

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Use Case 2 Security

Use program views to limit a users access to only those studies to which theyre authorized The DM_ALL dataset contains data for two studies but the user should only have access to one of them

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Security
The view program
Uses DM_ALL as the data source Generates the SECURITY_V table view

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Security

The view programs source code

Restricts access at the study level

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Security
The results in a business area visualization
Display only the study the user should be able to access

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Use Case 3 Data Blinding

Views on tables to mask data Authorize feature Multiple views for blinded/dummy data

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Q&A

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Contact Us
North America Sales Contacts: Rod Roderick, VP of Sales, Trial Management Solutions rroderick@biopharm.com +1 877 654 0033

Vicky Green, VP of Sales, Data Management Solutions vgreen@biopharm.com +1 877 654 0033

Europe/Middle East/Africa Sales Contact: Rudolf Coetzee, Director of Business Development rcoetzee@biopharm.com +44 (0) 1865 910200 General Inquiries: info@biopharm.com
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