Course Description:

Clinical trial management systems (CTMS) are not medical devices yet CTMS software is used to collect important clinical trial information for many products including medical devices and therefore should be validated. Available FDA guidance documents do not clearly describe how to validate a CTMS for the US market. CTMS developers, sponsors, site users and vendor/site auditors are left to interpret the clinical trial regulations and FDA guidance documents which are not directly applicable to CTMS software development.

For example, the software validation steps suggested and required for medical device software development may be appropriate for CTMS software in certain areas, but most of the medical device software requirements are not applicable to CTMS software development because the CTMS software is used for an entirely different purpose (i.e. intended use) than the medical device software. Many auditors point to the "General Principles of Software Validation" guidance and suggest rigorous medical device software validation principals which may not be the "least burdensome" path for CTMS software development. So what are the steps required for CTMS software validation and when is the CTMS software considered validated?

This course will review two FDA guidance documents related to software development in computerized systems including the "Computerized Systems Used in Clinical Investigations" which is clearly applicable to CTMS and the "General Principles of Software Validation" which is more directly applicable to software within a medical device. Attendees will understand how to use these guidance documents in a stepwise manner to create a robust CTMS software validation plan which should withstand an auditor’s scrutiny. Key features of a good CTMS software validation process will be presented and a review of the required Quality Management System and Standard Operating System documents will be discussed.

Learning Objectives:

  • Review two FDA guidance documents related to CTMS software development processes:
    • Computerized Systems Used in Clinical Investigations
    • General Principles of Software Validation
  • Understand the software validation requirements for CTMS systems
  • Develop a stepwise approach to CTMS software validation
  • Understand the key features of good CTMS software validation processes
  • Review the Quality Management System components (Standard Operating Procedures, Work Instructions and Forms) needed to support CTMS software validation

Who will Benefit:

  • Presidents and CEOs of CTMS providers
  • CTMS developers, testers auditors
  • Site Managers responsible for CTMS selection
  • Directors of Clinical and Regulatory Affairs
  • Managers of Quality Affairs
  • Clinical Research Coordinators & Associates
  • Clinical Project Managers, Research Nurses, Scientists and Others

Course Outline:

Day One     Day Two
  • Introductions - 15 Min
    • Instructor
    • Participants
  • Session 1: Session 1:  Overview of Validation - 30 Min
    • Definition of validation
    • Differences between CTMS and Medical Device Software
  • Session 2: Computerized Systems Used in Clinical Investigations - 60 Min
    • Requirements
    • Safeguards
    • System features
    • Personnel training
  • Break - 30 Min
  • Workshop: Developing a checklist from the guidance of required activities and features - 60 Min
  • Lunch - 60 Min
  • Session 3: General Principles of Software Validation - 60 Min
    • Verification
    • Validation documents
    • Software Development Life Cycle
  • Workshop: Developing a checklist from the guidance of required activities and features - 60 Min
  • Break - 30 Min
  • Interactive Session 4 (Facilitated Group Discussion): Software validation requirements for CTMS systems - 75 Min
    • What applies from the guidances
    • What doesn’t apply and why

  • Day 1 Recap - 15 Min
  • Session 5: Stepwise approach to CTMS software validation - 60 Min
    • Approach
    • Gap Analysis
    • Action Plans
  • Case Study: Gap Analysis and Action Plan - 60 Min
  • Break - 30 Min
  • Session 6: Quality Management System tools - 30 Min
    • SOPs and Work Instructions
    • Checklists
  • Q&A and Conclusions - 45 Min

Meet Your Instructor

Dr Joy Frestedt
President and CEO of Frestedt Incorporated

Dr. Frestedt is President and CEO of Frestedt Incorporated, a virtual Contract Research Organization including a corporate network of over 70 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs. Dr. Frestedt has over 30 years of experience in the health care, pharmaceutical, medical device and food-related industries assisting firms with strategic decisions involving clinical trials, successful regulatory negotiations and the development of quality management systems to compete globally. She has held key positions at Johnson and Johnson's Ortho Biotech, Medtronic, Mayo Clinical Trial Services, AstraZeneca Pharmaceuticals and Orphan Medical providing leadership and management for the development of pharmaceutical, medical device and food products.

Dr. Frestedt holds a BA in biology from Knox College and a PhD in pathobiology from the University of Minnesota Medical School. She is a member of the American Society of Clinical Oncologists, American Association of Pharmaceutical Scientists, Society of Clinical Research Associates, Association of Clinical Research Professionals (where she served as past chapter president and on the Editorial Advisory Board), and she is a Fellow and past chair of the ethics committee for the Regulatory Affairs Professionals Society. Dr. Frestedt recently founded Alimentix, the Minnesota Diet Research Center, was named interim Regulatory Director for the University of Minnesota Academic Health Center and she is one of the “100 Most Inspiring People in the Life Sciences Industry” by PharmaVOICE, 2011 as well as one of the top 25 “Industry Leaders” a “Women in Business Award” by the Minneapolis/St. Paul Business Journal, 2011.

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