The document discusses approaches to approving clinical trial trip reports in accordance with 21 CFR Part 11 regulations. It presents three methods: ink signatures, re-authentication of electronic signatures for status changes, and using a visible audit trail without re-authentication. Ink signatures are the most conservative but also most costly and cumbersome. A visible audit trail is most convenient but not compliant under conservative interpretations. Re-authentication provides a reasonable middle ground that is generally compliant. The document demonstrates each method and concludes by summarizing the tradeoffs.

1. Approaches to CTMS Trip
Report Approvals
November 7, 2012
Param Singh
Vice President of Clinical Trial
Management Solutions
BioPharm Systems, Inc.
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2. Welcome & Introductions
Param Singh
Vice President of Clinical Trial Management Solutions
BioPharm Systems, Inc.
• CTMS practice director since 2007
– Expertise in managing all phases and styles of clinical trials
– Leads the team that implements, supports, and enhances Oracle’s
LabPas and Siebel Clinical solutions
• Extensive Siebel Clinical implementation experience
– 11+ years of experience implementing Siebel Clinical
– 15+ implementations
– Spearheaded the creation of the Siebel Clinical “accelerator”
ASCEND
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3. Agenda
• 21 CFR Part 11
– Overview, Goals, & Signature Requirements
• Trip Report Approval Methods
– Ink, Re-authentication, & Visible Audit Trail
• Demo
• Summary
• Q&A
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4. 21 CFR Part 11 – Overview
• “21 CFR, Part 11 applies to records in electronic form, in
lieu of paper records, … under any records requirements
set forth in agency (FDA) regulations”
• Provides FDA criteria for when electronic records and
signatures are equivalent to their handwritten counterparts
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5. 21 CFR Part 11 – Goals
• Ensure same level of importance assigned to electronic
signatures as handwritten signatures
• Permit use of technology not considered when most
existing FDA regulations were written
• Maintain integrity of records and reports
• Allow industry and FDA to operate with flexibility and
efficiency
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6. 21 CFR Part 11 – Signature Requirements
• Electronic Signatures
– Must be unique to an individual with a verified identity
– Certified to FDA to be legally binding
• If Non-Biometric
– Two distinct components
• User ID and password
– Attempts at use by anyone but genuine owner require collaboration
of two or more individuals
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7. 21 CFR Part 11 – Signature Requirements (cont.)
• Signed Records Must Contain:
– Printed name of signer
– Date and time of execution
– Meaning of signature (review, approval, authorship, etc.)
• Signature/Record Linking
– Signatures must be linked to records (to which they were executed)
in a way that prevents falsification by ordinary means
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8. 21 CFR Part 11 – Equivalence
• If Requirements Fulfilled:
– “Electronic records … may be used in lieu of paper records”
– “… the agency will consider the electronic signatures to be
equivalent to full handwritten signatures, initials, and other general
signings”

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9. Trip Report Approval Methods
• Ink signatures
• Re-authentication for status changes
– Re-enter username and password
• Visible audit trail of status changes
Ink Re-authentication Visible Audit Trail
21 CFR Part 11 Interpretation
More Conservative Less Conservative
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10. Ink Signatures
• Pros
– Valid approval method for trip reports under most conservative
Part 11 interpretations
• Cons
– Need to maintain paper copies of signature pages
– Multiple copies need to be maintained in case of correction and
re-execution
– Greater time and cost
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11. Re-authentication for Status Changes
• Pros
– Approval is captured electronically
– Paper copies need not be maintained
– Searching for electronic trip reports is quicker and more efficient
than for paper copies
– Generally satisfies the more conservative interpretations of the rule
• Cons
– Requires additional time and cost to implement
– Requires the extra step of re-entering security credentials for
each approval
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12. Visible Audit Trail
• Pros
– Approval is captured electronically
– Re-approval of the trip report is easy
– Paper copies need not be maintained
– Searching for electronic trip reports is quicker and more efficient
than for paper copies
• Cons
– Not everyone is comfortable with this more liberal interpretation of
21 CFR Part 11
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13. Demo
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14. Summary
• Ink Signatures
– Most cumbersome and costly method
– Compliant under even the most conservative interpretations
• Visible Audit Trail (No Re-authentication)
– Most convenient
– Not compliant under more conservative interpretations
• Re-authentication
– Represents a reasonable middle ground
– Generally compliant under more conservative interpretations
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15. Thank you for attending!
Questions?
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16. Contact Us
• North America Sales Contact:
– Rod Roderick
– rroderick@biopharm.com
– +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
– Rudolf Coetzee
– rcoetzee@biopharm.com
– +44 (0) 1865 910200
• General Inquiries:
– info@biopharm.com
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17. Presenter – Param Singh
• Contact
– psingh@biopharm.com
– +1 210 454 5192
Param has been working in the life sciences industry his
entire career. As vice president of CTMS at BioPharm, he
developed the CTMS practice to become one of the best in
the industry.
With a knack for resource and project management, Param
leads a highly skilled team of implementation specialists and
continues to build lasting relationships with clients.
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