Optimizing Siebel CTMS with Electronic Trip Reports
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Transcript of Optimizing Siebel CTMS with Electronic Trip Reports
Optimizing Siebel CTMS with Electronic Trip Reports
Param Singh, Director of Clinical Trial Management SolutionsLife Sciences Business Unit
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Welcome & Introduction
Param SinghDirector of Clinical Trial Management SolutionsLife 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
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
• Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue ~$373 million
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• 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
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Welcome & Introductions
CTMS Practice Services
ImplementationManage implementations of Siebel CTMS/ASCEND and Mobile CRA.
IntegrationBuild interfaces between Siebel CTMS and other clinical and safety systems.
TrainingDevelop and/or deliver standard and custom training classes and materials.
Process GuidanceProvide insight, advice and solutions for specific CTMS issues based on industry best practices.
Today’s Agenda
Time Topic1:00‐1:05 Welcome and Introductions1:05‐1:10 Components of Trip Reports1:10‐1:25 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
Trip Report Components
• Site visit information• Checklist items• Narrative questions• Follow-up items• Additionally, for monitoring visits:
o Enrollment statisticso Serious Adverse Events (SAEs)o Protocol Deviations (PDs)o Monitored Case Report Forms (CRFs)
Trip Report Components
• Site visit informationo Protocolo Site #o PI Nameo Location/Site Nameo Visit Typeo Visit Start Dateo Visit End Dateo Visit Statuso Attendees
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.
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?
Trip Report Components
• Follow-up itemso Sub-I requires training in product handlingo New microscope needs to be set upo Need to obtain CDA from new staff nurseo No Internet access availableo Investigational product is not being stored in
proper conditions
Trip Report Components
• Additionally, for monitoring visits:o Enrollment statistics
o Current at time of visito Serious Adverse Events (SAEs)
o Monitored during visito Protocol Deviations (PDs)
o Monitored during visito Monitored Case Report Forms (CRFs)
o Monitored during visit
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
Adhere to SOPs
Siebel Clinical template functionalityo 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 SOPso Templates can be applied over and over for
each site visit to ensure consistency and streamline the completion process
Adhere to SOPs
Sample Monitoring Visit SOP
Adhere to SOPs
Sample Monitoring Trip Report Template
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
Track Review Process
• In Siebel CTMS, trip report “Status” field is governed by a state modelo 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 trailo 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
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
Siebel Clinical ASCEND
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Thank You!For more information, please contact:
[email protected]@perficient.com (Sales)
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