Considerations and Cahllenges when Interfacing InForm EDC to Argus

1. <Insert Picture Here>
Interfacing InForm to Argus Safety
Considerations & Challenges
Anil K Dhiri
Consulting Technical Manager, HSGBU

2. Agenda
• Safe Harbour
• Key Integration Driver
• Integration Considerations
• Challenges
• Conceptual O
C t l Overview
i
• Acknowledgements
• Q&A
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3. Safe Harbour
THE FOLLOWING IS INTENDED TO OUTLINE OUR GENERAL
PRODUCT DIRECTION. IT IS INTENDED FOR INFORMATION
PURPOSES ONLY AND MAY NOT BE INCORPORATED INTO ANY
ONLY,
CONTRACT. IT IS NOT A COMMITMENT TO DELIVER ANY
MATERIAL, CODE, OR FUNCTIONALITY, AND SHOULD NOT BE
RELIED UPON IN MAKING PURCHASING DECISIONS THE
DECISIONS.
DEVELOPMENT, RELEASE, AND TIMING OF ANY FEATURES OR
FUNCTIONALITY DESCRIBED FOR ORACLE’S PRODUCTS
REMAINS AT THE SOLE DISCRETION OF ORACLE.
3 © 2011 Oracle Corporation – Proprietary and Confidential

4. Key Integration Drivers
Business Drivers Design Element Benefits
Reduce data “First” time correct data Improved Data Quality
transcription errors transfer. & Knowledge Velocity.
“Single version of
truth
truth “
Reduce cost Direct data transfer to the Improved Flexibility,
target system. Speed up data entry.
Increased productivity Reduce Double Data Entry Increased Productivity
of Clinical & Safety
Operations. Reduce
transcription errors
t i ti
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5. Considerations
• InForm
• Patient Centric System
• Form based data (eCRFs) collection
• Forms & form design can change from one trial to another
• Very few/No data entry validations
g
• Data Standards for Information Exchange
• Conforms to CDISC
• Argus
• C
Case C t i S t
Centric System
• Events & Products relationships
• Data validations on data entry generally enforced to improve
data quality
• Data Standards for Information Exchange
g
• Conforms to ICH E2B for data transfer to regulators
© 2011 Oracle Corporation – Proprietary and Confidential

6. Challenges
• Data Extraction
• Logical mapping of safety data from eCRFs to target field
• Start with end in mind.
• Extraction windows
• Initial/Follow Ups
• Code list alignment between systems
• Products
• Units
• R t
Routes
• Managing Data with no target fields in Argus
© 2011 Oracle Corporation – Proprietary and Confidential

7. Challenges
• Management of Case Data in Argus for Case Processing
• UI Clean Up
• Product, Dosage Regimen Tabs
• Product Management & Synchronisation
• Initial & Follow-up
• No Drug Given (Blinded Trials)
• Study Product
• Event Synchronisation
• Managing Follow Up
• C
Case A l i
Analysis
• Data Updates on Follow up.
• Section deletions
• Individual field level deletions
• Attachment handling
• Initial & Follow Up
• Alignment of View Difference Report
• Ease of review
• Audit logs for single field deletions
© 2011 Oracle Corporation – Proprietary and Confidential

8. Mapping Example
Flat Fields Mapping Source Mapping Target
Mapping Field Source Type Value Function Description DB Target UI Target E2b Code/Text Inbound
Requireme Type (hardco Arguments value mapping /
nt ID ded) OR (calc) OR Post‐save
Functio Source Field details
n Name
n Name (direct)
(calc)
CM_CSI_E SAFETYREPO All Calculat fnc_saf Works out what should Not imported Not imported NA
2b‐FLAT‐ RTVERSION ed etyrepo be the next safetyreport
001 rtversio version for followup,
n() returns 01 if new, stops
at 99 (return 99 for all
values 99+) (dummy
l ) (d
argument because
safetyreport ID is not
known in InForm)
CM_CSI_E SAFETYREPO All Calculat fnc_saf Given the following: CASE_REFERE Case Form / NA
2b‐FLAT‐ RTID ed etyrepo patient id, form index NCE.REF_NO Additional Info /
002 rtid() provides unique
provides unique CASE_REFERE References / ID
CASE REFERE References / ID
identifier of the format NCE.REF_TYP Case Form /
TRIALID_SUBJECTNUMBE E_ID Additional Info /
R_SFORMINDEX CASE_REFERE References /
NCE.NOTES Type
Case Form /
Additional Info /
References /
Notes
© 2011 Oracle Corporation – Proprietary and Confidential

9. InForm Unique IDs (Section Level)
<patientepisodename>Diagnosis</patientepisodename>
<patientmedicalstartdateformat>102</patientmedicalstartdateformat>
<patientmedicalstartdate>20120918</patientmedicalstartdate>
<patientmedicalcontinue>2</patientmedicalcontinue>
<patientmedicalenddateformat>102</patientmedicalenddateformat>
<patientmedicalenddate>20120918</patientmedicalenddate>
<patientmedicalcomment>3 Severe AE</patientmedicalcomment>
<medhxid_extension>911001‐MHX‐M3‐001‐00</medhxid_extension>
<patientmedicalconditiontype_extension>Historical Condition</patientmedicalconditiontype_extension>
</medicalhistoryepisode>
/ di lhi t i d
© 2011 Oracle Corporation – Proprietary and Confidential

10. Conceptual Overview
© 2011 Oracle Corporation – Proprietary and Confidential

11. Typical Team
Project Management (Oracle/Client)
Argus Safety InForm
• SME •SME
•Technical Lead •Technical Lead
•Developer •Developer
Client
•SMEs
•Safety Group
•Clinical Development
•System Manager
Quality Assurance (Oracle/Client)
© 2011 Oracle Corporation – Proprietary and Confidential

12. Acknowledgements
• Francois Audibert
• Georgie Kennedy
• Syed Ali
• Durgadittya Nannapenni
© 2011 Oracle Corporation – Proprietary and Confidential

13. Wrap Up
13 © 2011 Oracle Corporation – Proprietary and Confidential