2013 ohsug - best practices for setting up the cda repository for ctms/oc

PREVIOUS NEXT PREVIOUS NEXT Oracle 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


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


Slide 3

Agenda

• What is CDA?

• Setting up development environment for review

• Establishing requirements

• Designing extensions

• Validating CDA

• Training

• Production Support

• On-going release life cycle


Slide 4

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 5

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.


Slide 6

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



Slide 7



Slide 8

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


Slide 9

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 10

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


Slide 11

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 12

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?


Slide 13

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 14

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


Slide 15

Example Star Schemas

Discrepancy Fact

Product

Study

•Study Team

Site

Study-Site

•Study-Site Team

Study Subject

Party

Case Report Form

Geography


Slide 16


Study Site Status Fact

Product

Program

Study

•Study Team

Study Region

Site

Study Site

•Study Site Team

Geography

Day


Slide 17


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

Site Study-Site

•Study-Site Team

Study Subject

Party

Case Report Form

Geography


Slide 18

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


Slide 19

Extending CDA - Adding a new OC Source Instance


Slide 20

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


Slide 21

OCDA Extensions- Adding a new Source (RAVE)


Slide 22

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


Slide 23

OCDA Extensions – Preserving Customizations on Upgrade


Slide 24

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


Slide 25

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


Slide 26

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 27

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?


Slide 28

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 29

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


Slide 30

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


Slide 31

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 32

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


Slide 33

Agenda

• What is CDA?




• Validating CDA

• Training




Slide 34

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?


Slide 35

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


Slide 36

Q&A


Slide 37

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


– +1 877 654 0033

• Europe/Middle East/Africa Sales Contact:

– Rudolf Coetzee, Director of Business Development


– +44 (0) 1865 910200

• General Inquiries:


2013 ohsug - best practices for setting up the cda repository for ctms/oc

Sports

cda requirements

cda repository

cda standard

oracle life sciences

development environment

oracle andor

clinical programs

siebel clinical