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Documentation in relation to drug management

Joanna Black

OCTRU

Tuesday, 12 June 2018, 10am to 11am

This session will cover the following:

  • Understanding the documentation required in relation to IMP for requesting Trial Authorisation
  • Understanding the need for Manufacturing licence for IMPs
  • Understanding the difference between QP Declaration certificate and QP release certificates
  • The need for Certificate of Analysis documentation
  • Drug accountability logs.
  • Special licence for the use of Specials
  • The difference between an IMP and a NIMP

 

Places need to be booked on this course.

Please email octrutrialshub@ndorms.ox.ac.uk to book.