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Interfacing In Form To Argus Safety

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Considerations and Cahllenges when Interfacing InForm EDC to Argus

Considerations and Cahllenges when Interfacing InForm EDC to Argus


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  • 1. <Insert Picture Here>Interfacing InForm to Argus SafetyConsiderations & ChallengesAnil K DhiriConsulting Technical Manager, HSGBU
  • 2. Agenda • Safe Harbour • Key Integration Driver • Integration Considerations • Challenges • Conceptual O C t l Overview i • Acknowledgements • Q&A© 2011 Oracle Corporation – Proprietary and Confidential
  • 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© 2011 Oracle Corporation – Proprietary and Confidential
  • 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 Up13 © 2011 Oracle Corporation – Proprietary and Confidential

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