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Auditing Clinical Trials for GCP Compliance

Jam-Packed with Checklists and Templates that can be IMMEDIATELY Implemented Back on the Job!

  • 12/08/2008 - 12/09/2008

    Washington, DC

  • 01/22/2009 - 01/23/2009

    San Diego, CA

  • 02/10/2009 - 02/11/2009

    Tampa, FL

  • 03/03/2009 - 03/04/2009

    Princeton, NJ

Interactive Elements

Adults and professionals learn better when the classroom is a vibrant, stimulating place. That's why we incorporate discussions, exercises and quizzes into all of our courses. These activities reinforce training and foster a practical, hands-on educational experience.

The following is one of several interactive elements incorporated in Auditing Clinical Trials for GCP Compliance. Refer to the course agenda on pages 4 and 5 for additional examples.

Practice Writing Audit Observations and Recommendations

  • Participants will read sample audit observations and write down their recommendations.
    • Observation I - Source Documentation - The medical histories for subjects reviewed were elicited by the study coordinator and entered on a study worksheet. There was no evidence that the Principal Investigator had reviewed the information, as no co-signature was present.
    • What is your recommendation?

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