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September, 2013
Mike Grossman
Vice President of Clinical Data Warehousing and Analytics BioPharm Systems
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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
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What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle
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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
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
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What is CDA? Setting up development environment for review Establishing requirements Designing extensions Validating CDA Training Production Support On-going release life cycle
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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
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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
Discrepancy Fact
Site
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Geography
Study
Study Team
Study Site
Study Site Team
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Party
Discrepancy Fact
Geography Geography
Program
Study Subject
Site Site
Study Region
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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 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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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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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
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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?
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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
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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
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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
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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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