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The Role of Quality Assurance in eClinical Environments – When to Dive In

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  • 1. The Role of Quality Assurance in eClinical Environments – When to Dive in Shiela McLaughlin International Director, Quality Assurance DATATRAK International, Inc.
  • 2. Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.Confidential – 3
  • 3. Introduction • Quality Assurance’s Role in eClinical Technologies ► 3rd Party Software/ COTS ► The Software Development Lifecycle (SDLC) ► Auditing Your Software Vendor • eSource / eClinical – The FDA’s PreferencesConfidential – 3
  • 4. QA’s Role in eClinical Technology • 3rd party software / COTS • Software developed in-house ► Do you have a Software Development Lifecycle? ► Does your process comply with applicable regulations • Outsourced / Vendor ► Have you qualified the vendor?Confidential – 3
  • 5. 3rd Party Software / COTS • Is it being modified or will it be used for its intended purpose? • Does it require validation? • Do you have a process / resources to validate?Confidential – 3
  • 6. The Software Development Lifecycle (SDLC) • The Old ModelConfidential – 3
  • 7. The Software Development Lifecycle (SDLC) • The New ModelConfidential – 3
  • 8. Auditing Your Software Vendor • Know the contract going into the audit • Don’t assume they know the regulations • Review their Software Development Lifecycles ► Development and release processes ► Disaster Recovery and Business Continuity ► Security processes and monitoring ► Support servicesConfidential – 3
  • 9. Auditing Your Software Vendor • Utilize a Subject Matter Expert (technical representation) • Check training records and employee qualifications • Check client referencesConfidential – 3
  • 10. eSource / eClinical - The FDA’s Preferences • General Principles of Software Validation: Final Guidance for Industry and FDA Staff (January 2002) • Guidance for Industry, Electronic Source Documentation in Clinical Investigations (December 2010)Confidential – 3
  • 11. eSource / eClinical - The FDA’s Preferences • Consolidation of electronic data Image from FDA’s DRAFT GUIDANCE: Electronic Source Documentation in Clinical Investigations (December 2010)Confidential – 3
  • 12. Conclusion • The use of technology and software in the clinical industry will only continue to increase • The involvement of Quality Assurance is becoming increasingly important • Regulatory bodies are recognizing and encouraging use of technology in the clinical industryConfidential – 3
  • 13. ®from Concept to Cure with DATATRAK ONE™ DATATRAK International Cleveland, Ohio Bryan, Texas Cary, North Carolina 888.677.DATA (3282) Toll Free www.datatrak.net

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