2013 OHSUG - Best Practices for Setting up the CDA Repository for CTMS/OC

PREVIOUS NEXTPREVIOUS NEXTOracle Health Sciences User group September 2013 Slide 1
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

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

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

Agenda
• What is CDA?
• Validating CDA
• Training

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.
What is Clinical Development Analytics?
This slide courtesy Oracle
Copyright © 2012, Oracle and/or its affiliates. All rights reserved.

CDA Warehouse &
Analysis Engine
What is Clinical Development Analytics?
CDA Presentation
Engine &
Role-based
Dashboards
Such as OC / RDC, Siebel Clinical, and third party systems
Clinical Development
Users from Executives
to Sites
View progress at the
organizational,
regional, study or site
level

OCDA Architecture
Ad-hoc Analysis Interactive Dashboards Proactive Alerts MS Office
Integration
Oracle BI Enterprise Edition Plus
Integrated Clinical Warehouse Built on Oracle Life Sciences Data Hub and 11gR2 RDBMS
CDA Informatica
SIL ETL CDA Clinical Warehouse
Schemas
CDA Staging Tables
Seibel Clinical
Duration of Open Discrepancies
iPhone
Integration
Note: SDE (Source Dependant Extract) / SIL (Source Independent Load)
Oracle Clinical
CDA Informatica
SDE ETL

Agenda
• What is CDA?
• Validating CDA
• Training

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

Agenda
• What is CDA?
• Validating CDA
• Training

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?

Agenda
• What is CDA?
• Validating CDA
• Training

Designing CDA Extensions
Extension Type Level of difficulty
Adding or modifying reports Low
Modifying existing Dashboards Low
Adding new dashboards Medium
Adding new measures and attributes to existing facts and
dimensions
Medium
Pool multiple OC instances Medium
Match merge dimensions from different sources Medium
Add new facts High
Add new data sources High
Add new dimensions High

Example Star Schemas
Discrepancy
Fact
Product
Study
•Study Team
Site
Study-Site
•Study-Site
Team
Study
Subject
Party
Case
Report
Form
Geography

Study Site
Status Fact
Product
Program
Study
•Study Team
Study
Region
Site
Study Site
•Study Site
Team
Geography
Day

Study Site
Status
Fact
Product
Program
Study
•Study Team
Study
Region
Site
Study Site
•Study Site
Team
Geography
Day
Discrepancy
Fact
Product
Study
•Study Team
SiteStudy-Site
•Study-Site
Team
Study
Subject
Party
Case
Report
Form
Geography

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

Extending CDA - Adding a new OC Source Instance

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

OCDA Extensions- Adding a new Source (RAVE)

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 SDE’s 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

OCDA Extensions – Preserving Customizations on Upgrade

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

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

Agenda
• What is CDA?
• Validating CDA
• Training

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?

Agenda
• What is CDA?
• Validating CDA
• Training

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

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

Agenda
• What is CDA?
• Validating CDA
• Training

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

Agenda
• What is CDA?
• Validating CDA
• Training

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?

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

Q&A

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

2013 OHSUG - Best Practices for Setting up the CDA Repository for CTMS/OC

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