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

1. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 1
Use Cases for using the
Program Type View
September, 2013
Mike Grossman
Vice President of
Clinical Data Warehousing and
Analytics
BioPharm Systems

2. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 2
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
Oracle’s 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

3. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 3
Agenda
• What is a view program
• Use case 1 – Data pooling
• Use case 2 – Data security
• Use case 3 – Data blinding

4. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 4
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

5. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 5
View Program

6. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 6
View Program Type

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Table Descriptors
• Multiple LSH data sources
• A single target table

8. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 8
Source Code

9. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 9
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 ]

10. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 10
Source Code
• Can only reference the program’s 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 view’s current data
• If you remove the view program instance the
corresponding table instance is also removed

13. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 13
View Data
From source DM
Data Currency
From source AE

14. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 14
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.

15. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 15
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

17. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 17
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

18. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 18
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 user’s access to only those
studies to which they’re 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 program’s 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

28. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 28
Use Case 3 – Data Blinding
• Views on tables to mask data
• Authorize feature
• Multiple views for blinded/dummy data

29. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 29
Q&A

30. PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 30
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