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

1. Optimizing Siebel CTMS with Electronic Trip Reports
Param Singh, Director of Clinical Trial Management Solutions
Life Sciences Business Unit
facebook.com/perficient twitter.com/perficient_LSlinkedin.com/company/perficient

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. 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. • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Adhere to SOPs
Sample Monitoring Visit SOP

18. Adhere to SOPs
Sample Monitoring Trip Report Template

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. 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. 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. Siebel Clinical ASCEND

24. www.facebook.com/perficient
www.perficient.com
www.twitter.com/perficient_LS
Thank You!
For more information, please contact:
Param.Singh@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+1 303 570 8464 (U.S. Sales)
+44 (0) 1865 910200 (U.K. Sales)