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Integrating Oracle Argus Safety with other Clinical Systems Using Argus Interchange's E2B Functionality
This document outlines the process for integrating Oracle Argus Safety with clinical systems using Argus Interchange's E2B functionality. It discusses identifying key stakeholders from IT, business, and quality assurance perspectives. It also covers system design, development and testing, implementation, and challenges. The example integration transfers data from source systems to Argus in an unidirectional manner using a combination of database manipulation, standardization to SDTM, and generation of E2B XML files for import into Argus. Extensive testing is recommended due to the custom development and regulatory implications.
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Integrating Oracle Argus Safety with other Clinical Systems Using Argus Interchange's E2B Functionality
- 1. PREVIOUS NEXTPREVIOUS NEXT IntegratingOracle 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
- 2. PREVIOUS NEXT Agenda • ProjectInitiation – Stakeholder Identification – System Design – Timeline • Development • Implementation • Challenges • Summary 2
- 3. PREVIOUS NEXT • StakeholderIdentification – 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 3
- 4. PREVIOUS NEXT • StakeholderIdentification – 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 4
- 5. PREVIOUS NEXT • ITNeeds – 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 5
- 6. PREVIOUS NEXT • SystemDesign Used in This Tutorial Project Initiation 6
- 7. PREVIOUS NEXT • ITNeeds 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 7
- 8. PREVIOUS NEXT • BusinessNeeds – 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 8
- 9. PREVIOUS NEXT • BusinessNeeds (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 9
- 10. PREVIOUS NEXT • BusinessNeeds 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 10
- 11. PREVIOUS NEXT • QANeeds – 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 11
- 12. PREVIOUS NEXT –What isthe timeline? Do any of the integrated systems have critical dates that may impact timeline? Project Initiation 12
- 13. PREVIOUS NEXT 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 13
- 14. PREVIOUS NEXT 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 14
- 15. PREVIOUS NEXT 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 15
- 16. PREVIOUS NEXT Development/Testing • Development/Testing –Argus configuration • Surface UD fields, configure products, studies, etc. • Enable Interchange and required AG Services 16
- 17. PREVIOUS NEXT Development/Testing • SynchronizeConfiguration – Code Lists • Challenges mapping free-text source to target code lists • Define process for error handling • Establish procedure for future updates 17
- 18. PREVIOUS NEXT Development/Testing • SynchronizeConfiguration (contd.) – Studies • Limitations on importing study products (ex. duplicate records) 18
- 19. PREVIOUS NEXT Development/Testing • SynchronizeConfiguration (contd.) – Products • Product names must match Argus Trade Names verbatim • Evaluate central product repository for ease of integration 19
- 20. PREVIOUS NEXT 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 20
- 21. PREVIOUS NEXT Development/Testing • DefineE2b(+) Tags – Add tags to DTD • Location must match order in E2b file Two Places 21
- 22. PREVIOUS NEXT Development/Testing • DefineE2b(+) Tags (cont.) – Insert tag records • Use SQL*Loader for convenience • Two tables: CFG_E2B and LM_ESM_ARGUS_MAPPING 22
- 23. PREVIOUS NEXT Development/Testing • DefineE2b(+) Tags (cont.) – Add Receive Code • PL/SQL block per tag leveraging Argus API • Helpful to use existing tags as examples 23
- 24. PREVIOUS NEXT Development/Testing • DefineE2b(+) 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 24
- 25. PREVIOUS NEXT Development/Testing • AddE2b(+) Profile – Copy existing Profile to create new Profile – Check “Extended E2b” 25
- 26. PREVIOUS NEXT Development/Testing • CreateE2b(+) Profile DTD – Copy and rename existing DTD – Link profile to DTD 26
- 27. PREVIOUS NEXT Development/Testing • E2bValidation 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 27
- 28. PREVIOUS NEXT 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? 28
- 29. PREVIOUS NEXT Development/Testing • ConfigureReporting Destination Reporting Destination Code List ESM Mapping 29
- 30. PREVIOUS NEXT Development/Testing • Development/Testing –Testing • Iterative process involving user groups • Include several cycles of end-to-end testing 30
- 31. PREVIOUS NEXT 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) 31
- 32. PREVIOUS NEXT • 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 32 Challenges
- 33. PREVIOUS NEXT • ProjectInitiation – Stakeholder Identification – System Design – Timeline • Development • Implementation • Challenges • Summary 33 Summary
- 34. PREVIOUS NEXT • O’Carroll,P. (2003). Public Health Informatics and Information Systems. Springer 34 References
- 35. PREVIOUS NEXT35 Contact • NorthAmerica 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