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Integrating Oracle Argus Safety with
Clinical Systems Using Argus
Interchange's E2B Functionality
February 13, 2014
Rodney Lemery, MPH, PhD
Vice President, Safety and
Pharmacovigilance
BioPharm Systems

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Agenda
• Project Initiation
– Stakeholder Identification
– System Design
– Timeline
• Development
• Implementation
• Challenges
• Summary
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• Stakeholder Identification
– All information systems implementation projects in the area
of health information begin by identifying key stakeholders.
– These stakeholders must work in concert and collaboration
in order to achieve their objectives as all of them are
involved in the planning and execution of the project
(O’Carroll et al., 2003)
Project Initiation
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• Stakeholder Identification
– O’Carroll et al describe these stakeholders as two camps:
• IT View
• Business View
– Some have suggested that given our field’s stress on the
regulatory process that a third camp also be considered:
• QA View
Project Initiation
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• IT Needs
– How will the integration actually process?
• Direct database to database connectivity?
• Web services?
• What is the system architecture being used?
– The unique case ID that intermediate system may generate
– is there any value in it being an intelligent key like
• <STUDY>_<USUBJID>_<AESEQ>_<SOME_SEQ_NUMBER>
• Or should it be a plain sequence number?
– Is the integration unidirectional or bi-directional between
the systems?
Project Initiation
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• System Design Used in This Tutorial
Project Initiation
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• IT Needs Answers in this Practical Example
– How will the integration actually process?
• A combination of database table manipulation in the LSH
system resulting in the generation of an E2b(+) XML file
that will be moved using Web Services into the
appropriate Incoming folder for Argus Interchange
– Is the integration unidirectional or bi-directional
between the systems?
• The integration is unidirectional only as the OLX and
OC/RDC systems are considered source by this client
Project Initiation
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• Business Needs
– When should data be triggered for transfer from the source
to the target systems?
• Daily, Hourly?
– What specific data should be copied from the source to the
target system?
• All laboratory data?
• All medical history data?
– It is typical practice in a traditional safety practice to only enter the
laboratory tests and medical history data for a participant that are
deemed “medically relevant” to the event of interest for the case.
How does this clinically challenging concept get applied to an
information system?
Project Initiation
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• Business Needs (cont.)
• Every event?
– Many companies use Argus to track more than just
adverse event data. Some use it to track quality
issues, device failure terms, medical information data
and registry information just to name a few.
– What constitutes a “case” in the source system?
Project Initiation
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• Business Needs Used in This Tutorial
– When should data be triggered for transfer from the source
to the target systems?
• This example integration has 5 data movements that
require scheduling
1. OLX and OC/RDC data into LSH
2. Transformation of LSH data into SDTM standard
3. Creation of E2b(+) XML file from the SDTM standardized data
and queue for transfer
4. Transfer of XML file to network share via Web Methods
5. Import into Argus via Interchange
Project Initiation
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• QA Needs
– Most of our client base would see this type of work as custom
development and place a risk level of medium to high in its
development
– This would mean a significant amount of testing usually in a phased
approach popular with the FDA regulations
• IQ – Installation Qualification
– Phase responsible for the documentation and testing of the installation process
according to the system design documentation and usually governed by its own
protocol and summary report.
• OQ – Operational Qualification
– Phase responsible for the functional testing of the system according to the
functional requirements specification and usually governed by its own protocol
and summary report.
• PQ – Performance Qualification
– Phase responsible for the user acceptance testing of the system according to
the user requirements specification and usually governed by its own protocol
and summary report.
Project Initiation
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–What is the
timeline? Do any
of the integrated
systems have
critical dates that
may impact
timeline?
Project Initiation
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Development/Testing
• Development/Testing
– Mapping – Must occur before development
begins; iterative process involving users
• Used to identify source for standard E2B fields and
to define required extended tags
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Development/Testing
• Mapping
– First phase of development; Iterative process involving users
– Document the source locations, E2b tags, and Argus target fields
– Map standard E2b tags and define required E2b(+) tags
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Development/Testing
• Mapping (contd.)
– Source
• Multi-record data mapped to repeating E2b sections
• “Where Clause” can be specified for added granularity
• Special consideration given to max. lengths across mapping
– E2b Tag
• Leverage default E2b tags where possible
• Define placement and order of E2b(+) tags within standard sections
• E2b(+) tags names: “_EXTENSION” and <= 30 characters in Argus
– Target (Argus)
• Identify code list mappings
• Surface user defined fields if necessary
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Development/Testing
• Development/Testing
– Argus configuration
• Surface UD fields, configure products, studies, etc.
• Enable Interchange and required AG Services
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Development/Testing
• Synchronize Configuration
– Code Lists
• Challenges mapping free-text source to target code lists
• Define process for error handling
• Establish procedure for future updates
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Development/Testing
• Synchronize Configuration (contd.)
– Studies
• Limitations on importing study products (ex. duplicate records)
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Development/Testing
• Synchronize Configuration (contd.)
– Products
• Product names must match Argus Trade Names verbatim
• Evaluate central product repository for ease of integration
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Development/Testing
• Development/Testing
– Develop Argus custom profile and extended tags
• Define custom, extended profile in ESM and custom DTD file
• Load extended tags in CFG_E2B and
LM_ESM_ARGUS_MAPPING tables
• Add extended tags to DTD
• Develop custom import/export programming per extended
tag.
– Most of the export code is defined at the parent tag level (ex.
“drug”) while the import code is defined per tag
– Import code leverages PL/SQL and Argus API while export code
is basic SQL
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Development/Testing
• Define E2b(+) Tags
– Add tags to DTD
• Location must match order in E2b file
Two Places
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Development/Testing
• Define E2b(+) Tags (cont.)
– Insert tag records
• Use SQL*Loader for convenience
• Two tables: CFG_E2B and LM_ESM_ARGUS_MAPPING
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Development/Testing
• Define E2b(+) Tags (cont.)
– Add Receive Code
• PL/SQL block per tag leveraging Argus API
• Helpful to use existing tags as examples
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Development/Testing
• Define E2b(+) Tags (cont.)
– Add Transmit Code
• Only required for outgoing files (i.e. when Argus is the source)
• Basic SQL, usually defined at the parent element level (ex. Patient)
• Verify “Column Position” in CFG_E2B matches SELECT statement order
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Development/Testing
• Add E2b(+) Profile
– Copy existing Profile to create new Profile
– Check “Extended E2b”
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Development/Testing
• Create E2b(+) Profile DTD
– Copy and rename existing DTD
– Link profile to DTD
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Development/Testing
• E2b Validation Rules
– Modify for E2b(+) profile to ease import restrictions
• Incoming files only need to meet minimum Argus case creation
requirements (not regulatory ICSR requirements)
• Minimize number of “mandatory” and “mandatory optional” tags
– CFG_E2B Table
• Update MANDATORY and MANDATORY_DTD_ELEMENT columns
– CFG_M2_ADDITIONAL Table
• Contains additional E2b validation rules
• Rules can be added/removed according to requirements
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Development/Testing
• Development/Testing
– Configure Integration Points
• Argus reporting destination configured to point to
incoming/outgoing directories via Argus ESM
(network paths ok)
• Mechanism for moving E2B files to/from
directories?
– Web services?
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Development/Testing
• Configure Reporting Destination
Reporting Destination
Code List
ESM Mapping
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Development/Testing
• Development/Testing
– Testing
• Iterative process involving user groups
• Include several cycles of end-to-end testing
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Implementation/Maintenance
• Implementation/Maintenance
– Consider phased rollout – ex. individual studies or limited data
points supplemented by manual data entry
– Define process for configuration changes across systems –
Changes can impact multiple systems (ex. configuring a new
product or study)
– Define process for bridge modifications (ex. addition of new
extended tag)
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• Gotchas (examples)?
– Synchronizing configuration across systems (ex. product configuration)
– E2B tag order must be appropriately configured within CFG_E2B table
and match export SQL select order
– Extended tag names cannot exceed 30 characters
– Cannot add new parent tags or repeating sections
– Default logic for importing study products (potential for duplicate
products)
• Argus creates a single study product even if multiple products are delivered
to the patient
– Carefully consider enabling Argus auto-acceptance
• Business implications
– Known limitations with device products
– Working within standard E2B specification
• eMDR standards use HL7 formatted files
– Argus does not delete records or clear out values on import of follow-ups
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Challenges

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• Project Initiation
– Stakeholder Identification
– System Design
– Timeline
• Development
• Implementation
• Challenges
• Summary
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Summary

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• O’Carroll, P. (2003). Public Health Informatics and
Information Systems. Springer
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References

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Contact
• 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) 7810 373045
• General Inquiries:
info@biopharm.com