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Optimizing Siebel CTMS with Electronic Trip Reports


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Completing clinical and site visit trip reports electronically through a clinical trial management system (CTMS) saves sponsors and research organizations time and money. However, due to their unfamiliarity with how they work and how 21 CFR Part 11 pertains to electronic signatures, companies shy away from utilizing electronic trip report solutions to their full capacity.

In this slideshare we cover:

Components of trip reports
Common trip report challenges
Live demo of trip report completion and approval process in Siebel CTMS

Published in: Technology
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Optimizing Siebel CTMS with Electronic Trip Reports

  1. 1. Optimizing Siebel CTMS with Electronic Trip Reports Param Singh, Director of Clinical Trial Management Solutions Life Sciences Business Unit
  2. 2. Welcome & Introduction Param Singh Director of Clinical Trial Management Solutions Life Sciences, Perficient • CTMS practice head since 2008 – Leads the team that implements, supports, enhances and integrates Oracle’s CTMS solution • Extensive Siebel CTMS implementation experience – 14+ years of experience implementing Siebel CTMS – 30+ implementations and integrations – Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel CTMS
  3. 3. Perficient is a leading information technology consulting firm serving clients throughout North America and Europe. We help clients implement business-driven technology solutions that integrate business processes, improve worker productivity, increase customer loyalty and create a more agile enterprise to better respond to new business opportunities. About Perficient
  4. 4. • Founded in 1997 • Public, NASDAQ: PRFT • 2013 revenue ~$373 million • Major market locations throughout North America • Atlanta, Boston, Charlotte, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Los Angeles, Minneapolis, New Orleans, New York City, Northern California, Philadelphia, Southern California, St. Louis, Toronto and Washington, D.C. • Global delivery centers in China, Europe and India • >2,100 colleagues • Dedicated solution practices • ~85% repeat business rate • Alliance partnerships with major technology vendors • Multiple vendor/industry technology and growth awards Perficient Profile
  5. 5. BUSINESS SOLUTIONS Business Intelligence Business Process Management Customer Experience and CRM Enterprise Performance Management Enterprise Resource Planning Experience Design (XD) Management Consulting TECHNOLOGY SOLUTIONS Business Integration/SOA Cloud Services Commerce Content Management Custom Application Development Education Information Management Mobile Platforms Platform Integration Portal & Social Our Solutions Expertise
  6. 6. Life SciencesPractices/Solutions Implementation Migration Integration Validation Consulting Upgrades Managed Services Application Development Private Cloud Hosting Application Support Sub-licensing Study Setup Services Deep Clinical and Pharmacovigilance Applications Expertise Clinical Trial Management Clinical Trial Planning and Budgeting Oracle ClearTrial CTMS Oracle Siebel CTMS / ASCEND Mobile CRA Clinical Data Management & Electronic Data Capture CDMS Oracle Clinical Electronic Data Capture Oracle Remote Data Capture Oracle InForm Medical Coding Oracle Thesaurus Management System Safety & Pharmacovigilance Adverse Event Reporting Oracle Argus Safety Suite Oracle AERS / EmpiricaTrace Axway Synchrony Gateway Signal Management Oracle Empirica Signal/Topics Medical Coding Oracle Thesaurus Management System Clinical Data Warehousing & Analytics Clinical Data Warehousing Oracle Life Sciences Data Hub Clinical Data Analytics Oracle Clinical Development Analytics JReview Data Review and Cleansing Oracle Data Management Workbench Clients
  7. 7. Welcome & Introductions CTMS Practice Services Implementation Manage implementations of Siebel CTMS/ASCEND and Mobile CRA. Integration Build interfaces between Siebel CTMS and other clinical and safety systems. Training Develop and/or deliver standard and custom training classes and materials. Process Guidance Provide insight, advice and solutions for specific CTMS issues based on industry best practices.
  8. 8. Today’s Agenda Time Topic 1:00‐1:05 Welcome and Introductions 1:05‐1:10 Components of Trip Reports 1:10‐1:25 Common Trip Report Challenges • Adhere to SOPs • Capture Snapshot in Time • Track Throughout Review Process • Record Compliant Approvals 1:25‐1:45 Live Demo of Trip Report Completion & Approval in  Siebel CTMS ASCEND 1:45‐2:00 Q&A
  9. 9. Trip Report Components • Site visit information • Checklist items • Narrative questions • Follow-up items • Additionally, for monitoring visits: o Enrollment statistics o Serious Adverse Events (SAEs) o Protocol Deviations (PDs) o Monitored Case Report Forms (CRFs)
  10. 10. Trip Report Components • Site visit information o Protocol o Site # o PI Name o Location/Site Name o Visit Type o Visit Start Date o Visit End Date o Visit Status o Attendees
  11. 11. Trip Report Components • Checklist items (yes/no) o Site staff training records are current. o Site regulatory binder is complete. o Each informed consent form is countersigned and dated. o Investigational product is being stored appropriately. o Investigational product supply is adequate for anticipated enrollment.
  12. 12. Trip Report Components • Narrative questions (open-ended) o How would you describe the site's compliance with the informed consent policy? o How would you describe the site's compliance with the drug accountability procedure? o How would you describe the site’s overall management of study-related documentation?
  13. 13. Trip Report Components • Follow-up items o Sub-I requires training in product handling o New microscope needs to be set up o Need to obtain CDA from new staff nurse o No Internet access available o Investigational product is not being stored in proper conditions
  14. 14. Trip Report Components • Additionally, for monitoring visits: o Enrollment statistics o Current at time of visit o Serious Adverse Events (SAEs) o Monitored during visit o Protocol Deviations (PDs) o Monitored during visit o Monitored Case Report Forms (CRFs) o Monitored during visit
  15. 15. Trip Report Challenges • Adhere to site visit SOPs • Capture a snapshot in time for when the site visit occurred • Track the report throughout the review process • Record compliant approvals
  16. 16. Adhere to SOPs Siebel Clinical template functionality o Allows an administrator to create an outline, or template, of each type of site visit - usually qualification, initiation, monitoring and close- out o Templates can be set up to mirror SOPs o Templates can be applied over and over for each site visit to ensure consistency and streamline the completion process
  17. 17. Adhere to SOPs Sample Monitoring Visit SOP
  18. 18. Adhere to SOPs Sample Monitoring Trip Report Template
  19. 19. Capture a Snapshot in Time • In ASCEND, Siebel CTMS is configured so that follow-up items, PDs, SAEs and CRF monitoring activities are tracked outside of the trip report • When a trip report is ready to be completed, the relevant records can be “imported” o Creates a read-only copy that cannot be modified within the trip report
  20. 20. Track Review Process • In Siebel CTMS, trip report “Status” field is governed by a state model o Controls order of status changes and which users can make which changes • In ASCEND, trip report includes electronic signature capability with re-authentication and a visible audit trail o Displays complete history of status changes • In both, the printable trip report does not display reviewer comments, but electronic version does store them, unless deleted
  21. 21. Record Compliant Approvals • Ink signatures • Re-authentication for status changes • Visible audit trail of status changes More Conservative Less Conservative Visible audit  trailRe‐authentication 21 CFR Part 11 Interpretation Ink
  22. 22. Siebel Clinical ASCEND
  23. 23. Thank You! For more information, please contact: (Sales) +1 303 570 8464 (U.S. Sales) +44 (0) 1865 910200 (U.K. Sales)