Use of Notes to File in Clinical Trial Essential Documentation November 2018

Nov 13, 2018
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Course Description

Notes to File (NTF), also known as Memo to File, are commonly used as essential documentation in sponsor and site files. Many times the content of the NTF does not serve the purpose for use or serves no purpose at all. This web seminar will discuss the appropriate and inappropriate uses of NTF, the questions to ask to determine if NTF would be beneficial, and the components of a quality NTF, if being used.

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Learning Objectives

  • Discuss the current overuse and misuse of NTF, including FDA Warning
  • Letters noting deficiencies in interventions that include NTF
  • Identify what is an appropriate NTF, patient and non-patient specific
  • Compose an effective NTF, when applicable
  • Describe reference industry tools relating to NTF

Who Should Attend

  • Quality Assurance Personnel
  • Clinical Research Associates
  • Clinical Research Coordinators
  • Investigators
  • Clinical Research Associate Managers
  • Project Managers

Instructor

Gary B. Freeman, M.S.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.