Integration of Argus and Other Products Using the E2b Interchange

September 13, 2013

Rodney Lemery, MPH, PhD Vice President, Safety and Pharmacovigilance BioPharm Systems, Inc.
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Agenda
Project Initiation
Stakeholder Identification System Design Timeline

Development Implementation Challenges Summary

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Project Initiation
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 (OCarroll et al., 2003)

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Project Initiation
Stakeholder Identification
OCarroll et al describe these stakeholders as two camps:
IT View Business View

Some have suggested that given our fields stress on the regulatory process that a third camp also be considered:
QA View

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Project Initiation
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?

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Project Initiation
System Design Used in This Tutorial

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Project Initiation
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
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Project Initiation
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?
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Project Initiation 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?

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Project Initiation
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. 2. 3. 4. 5. OLX and OC/RDC data into LSH Transformation of LSH data into SDTM standard Creation of E2b(+) XML file from the SDTM standardized data and queue for transfer Transfer of XML file to network share via Web Methods Import into Argus via Interchange

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Project Initiation
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. 1 PREVIOUS NEXT
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Project Initiation
What is the timeline? Do any of the integrated systems have critical dates that may impact timeline?

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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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Challenges
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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Summary
Project Initiation
Stakeholder Identification System Design Timeline

Development Implementation Challenges Summary

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References
OCarroll, P. (2003). Public Health Informatics and Information Systems. Springer

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Contact

Rodney L. Lemery MPH, PhD Vice Pres. Safety and PV 2000 Alameda de las Pulgas Suite 154 San Mateo, CA 94403-1270 www.biopharm.com Tel (650) 292-5310 Fax (650) 292-5301 rlemery@biopharm.com

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