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Use of Notes to File in Clinical Trial Essential Documentation October 2011

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 NTF’s content does not serve the purpose for use or serve no purpose at all. This web seminar will discuss the appropriate and inappropriate uses of Notes to File, the questions to ask to determine if an 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
  • Write an effective NTF, when applicable
  • Reference industry tools relating to NTF

Who Should Attend

  • Quality Assurance Personnel
  • CRAs
  • CRCs
  • Investigators
  • CRA Managers
  • Project Managers

Instructor

Gary B. Freeman, M.S., C.C.R.A., C.C.R.T

Click here for complete trainer biographies 

Course Length Time

1.5 hours; 8:30 - 10:00 a.m. Eastern

Course Dates

October 17, 2011

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
 

 

 

 

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)