Approaches to CTMS Trip Report Approvals


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Approaches to CTMS Trip Report Approvals

  1. 1. Approaches to CTMS TripReport Approvals November 7, 2012 Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc. 1 PREVIOUS PREVIOUS NEXT NEXT
  2. 2. Welcome & IntroductionsParam SinghVice President of Clinical Trial Management SolutionsBioPharm 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 2 PREVIOUS PREVIOUS NEXT NEXT
  3. 3. Agenda• 21 CFR Part 11 – Overview, Goals, & Signature Requirements• Trip Report Approval Methods – Ink, Re-authentication, & Visible Audit Trail• Demo• Summary• Q&A 3 PREVIOUS PREVIOUS NEXT NEXT
  4. 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 4 PREVIOUS PREVIOUS NEXT NEXT
  5. 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 5 PREVIOUS PREVIOUS NEXT NEXT
  6. 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 6 PREVIOUS PREVIOUS NEXT NEXT
  7. 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 7 PREVIOUS PREVIOUS NEXT NEXT
  8. 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”  8 PREVIOUS PREVIOUS NEXT NEXT
  9. 9. Trip Report Approval Methods• Ink signatures• Re-authentication for status changes – Re-enter username and password• Visible audit trail of status changesInk Re-authentication Visible Audit Trail 21 CFR Part 11 Interpretation More Conservative Less Conservative 9 PREVIOUS PREVIOUS NEXT NEXT
  10. 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 10 PREVIOUS PREVIOUS NEXT NEXT
  11. 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 11 PREVIOUS PREVIOUS NEXT NEXT
  12. 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 12 PREVIOUS PREVIOUS NEXT NEXT
  14. 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 14 PREVIOUS PREVIOUS NEXT NEXT
  15. 15. Thank you for attending!Questions? 15 PREVIOUS PREVIOUS NEXT NEXT
  16. 16. Contact Us• North America Sales Contact: – Rod Roderick – – +1 877 654 0033• Europe/Middle East/Africa Sales Contact: – Rudolf Coetzee – – +44 (0) 1865 910200• General Inquiries: – 16 PREVIOUS PREVIOUS NEXT NEXT
  17. 17. Presenter – Param Singh• Contact – – +1 210 454 5192Param has been working in the life sciences industry hisentire career. As vice president of CTMS at BioPharm, hedeveloped the CTMS practice to become one of the best inthe industry.With a knack for resource and project management, Paramleads a highly skilled team of implementation specialists andcontinues to build lasting relationships with clients. 17 PREVIOUS PREVIOUS NEXT NEXT