2013 OHSUG - Use Cases for using the Program Type View in Oracle Life Sciences Data Hub (LSH)

7/27/2019 2013 OHSUG - Use Cases for using the Program Type View in Oracle Life Sciences Data Hub (LSH)

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PREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 1

Use Cases for using the

Program Type View

September, 2013

Mike GrossmanVice President of

Clinical Data Warehousing and

Analytics

BioPharm Systems


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Welcome & Introductions

Mike GrossmanVice President ofClinical Data Warehousing and AnalyticsBioPharm 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 integratesOracles 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


7/30PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 7

Table Descriptors

Multiple LSH data sources

A single target table



Source Code



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 ]



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



View Table



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



View Data

From source DM

Data Currency

From source AE



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.



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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PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 16

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 codeand 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

[email protected]

+1 877 654 0033

Vicky Green, VP of Sales, Data Management Solutions

[email protected]

+1 877 654 0033

Europe/Middle East/Africa Sales Contact: Rudolf Coetzee, Director of Business Development

[email protected]

+44 (0) 1865 910200

General Inquiries:

[email protected]

2013 OHSUG - Use Cases for using the Program Type View in Oracle Life Sciences Data Hub (LSH)

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