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Best Practices for Setting up the CDA Repository for CTMS/OC

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

Oracle Health Sciences User group September 2013

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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 CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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What is Clinical Development Analytics?


Oracle Health Sciences Clinical Development Analytics is a comprehensive analytics solution that provides sponsors and CROs timely, fact-based insight into clinical programs to make more informed business decisions, increase R&D productivity, and develop drugs more effectively.

This slide courtesy Oracle


Copyright 2012, Oracle and/or its affiliates. All rights reserved.

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What is Clinical Development Analytics?


CDA Presentation Engine & Role-based Dashboards

Clinical Development Users from Executives to Sites

CDA Warehouse & Analysis Engine

View progress at the organizational, regional, study or site level

Such as OC / RDC, Siebel Clinical, and third party systems


This slide courtesy Oracle
Copyright 2012, Oracle and/or its affiliates. All rights reserved.

Oracle Health Sciences User group September 2013

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This slide courtesy Oracle


Copyright 2012, Oracle and/or its affiliates. All rights reserved.

Oracle Health Sciences User group September 2013

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OCDA Architecture
Oracle BI Enterprise Edition Plus
Duration of Open Discrepancies

Ad-hoc Analysis

Interactive Dashboards

Proactive Alerts

MS Office Integration

iPhone Integration

Integrated Clinical Warehouse Built on Oracle Life Sciences Data Hub and 11gR2 RDBMS
CDA Informatica SDE ETL CDA Staging Tables

CDA Informatica SIL ETL

CDA Clinical Warehouse Schemas

Oracle Clinical
Note: SDE (Source Dependant Extract) / SIL (Source Independent Load)

Seibel Clinical
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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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Setting up development environment for review


Before establishing requirements, users need to see the reports and dashboards with a pure out-of-the-box installation With over 900 measures there is no more cost-effective way to independently establish requirements without looking at the out-of-the-box reports Typically it takes 1-3 weeks to set up a development environment

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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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Establishing CDA Requirements


Who will be using the dashboards and what questions are they trying to answer? What are the source systems
Seibel Clinical Only? One or more OC instances?

Have the source systems been customized? Do the existing reports need to be validated? Do new reports need to be created? What are the corporate BI and warehousing standards? How are common entities matched between sources? Will CDA standard or plus be needed?
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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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Designing CDA Extensions


Extension Type Adding or modifying reports Modifying existing Dashboards Adding new dashboards Level of difficulty Low Low Medium

Adding new measures and attributes to existing facts and Medium dimensions Pool multiple OC instances Match merge dimensions from different sources Add new facts Add new data sources Add new dimensions
Oracle Health Sciences User group September 2013

Medium Medium High High High


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Example Star Schemas


Product Geography Study
Study Team

Case Report Form

Discrepancy Fact

Site

Study-Site Party Study Subject


Study-Site Team

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Example Star Schemas


Product
Day Program

Geography

Study Site Status Fact

Study
Study Team

Study Site
Study Site Team

Study Region Site

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Example Star Schemas


Product Product
Day

Case Report Form Study Study


Study StudyTeam Team

Party

Discrepancy Fact
Geography Geography

Study Site Status Fact

Program

Study Subject

Study-Site Study Site


Study Study-Site Site Team Team

Site Site

Study Region

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OCDA Extension Examples


Multiple OC Instances Sources other than/in addition to OC and SC Preserving customizations across OCDA releases
Various customizations to vanilla SC product Additional Operating Metrics not supported out-of-the-box by OCDA

Duplicate Study, Site, Subject, etc data in OC and SC

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Extending CDA - Adding a new OC Source Instance

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OCDA Implementation Challenges - Adding a new OC Source Instance-Notes No new programming, only LSH configuration to define new staging area for the new OC instance SDE logic same as shipped by Oracle Use of LSH View Object to pool data from the 2 OC instances Assumption: no common study or other data among the various sources Note: Control Table Logic needs to be modified to make sure the additional pooling step does not break the incremental load logic
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OCDA Extensions- Adding a new Source (RAVE)

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OCDA Implementation Challenges - Adding a new Source (RAVE) Each source entity must be conformed to the source independent structure Very careful design and development needed for defining new SDEs for RAVE and conforming them to the structure that OCDA Pooling area expects High effort Assumption: no common study or other data among the various sources

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OCDA Extensions Preserving Customizations on Upgrade

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OCDA Extensions Preserving Customizations on Upgrade

Advantages
Clean separation of Oracle shipped OCDA code from customized code All ETL and Table Instances point to the original Oracle shipped definitions unless customized Central control table controlling incremental load for the entire OCDA installation Upgrades are safe and clean: all Oracle-shipped upgrades are applied to OCDA_domain, thus not impacting any production code. Automation can help compare differences between Oracle-shipped code and Production code making the decision to selectively accept the upgrades easier
Note: Control Table logic needs to be changed slightly to visually identify the various programs from different domains and selectively wipe out incremental load data when doing a full load for a domain
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Merging OC and SC Dimensions


OCDA has match-merge capability built in
Winner-Donor mapping table Winner-Donor may be populated with Oracle Healthcare Master Person Index (OHMPI) Dimension SILs populate winner information in Dimension records based on the input from mapping table

Determine and design how to populate the mapping table based on customer interviews Implement logic in the ETL flow to populate mapping table before Dimension SIL runs
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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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Validating CDA
Does formal 21 CFR PART 11 apply? Are the source systems formally validated? Is there formal OQ for extensions to CDA? Does every pre-built report need to be validated? What is considered to be evidence of testing? Do you test from source to warehouse and then ware house to report or from source to report?

Oracle Health Sciences User group September 2013

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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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CDA Training
Just in time CDA End User (1/2 day)
Understanding the user interface Using the Clinical Operations dashboards and reports Using the Data Management dashboards and reports Exporting report outputs and briefing books Working with Requests Working with My Dashboard

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CDA Training
CDA Definer (1 day)
Overview of CDA and its architecture Understanding the user interface Overview of the CDA Dashboards Managing Catalogs Working with Requests Working with Dashboards Working with Prompts Exporting report outputs CDA Security Running the CDA ETL programs Extending CDA
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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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Production Support
Establish a service level during requirements Monitoring the ETL process
LSH Notification for CDA Plus Enterprise Manager DAC for CDA Standard

Monitoring OBIEE server Assisting end users report design User/PW changes for CDA
Authentication method for CDA standard

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Agenda
What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle

Oracle Health Sciences User group September 2013

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On-going release life cycle


Separate official validated reports on separate dashboards that are clearly identifiable Start with a few key validated reports and grow over time Add new reports validated at least 3 times per year Allow for dashboards with non-validated reports as long as they are clearly identified The CDA test environment using production data sources. What are the rules?

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Conclusions
CDA can be deployed rapidly out-of-the-box for end user review Extend at lowest effort item where applicable Formal requirements and design for warehouse extensions Design for future upgrades Just in time training Empower the business users to create reports and dashboards Validate small key portions and grow the validated set over time
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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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