This session covers:

  • Understanding the documentation required in relation to IMP for requesting trial authorisation
  • Understanding the need for a manufacturing licence for IMPs
  • Understanding the difference between QP Declaration certificates 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 reserve your space.