Documentation in relation to drug management
Joanna Black
OCTRU
Tuesday, 27 June 2017, 10am to 12pm
Botnar Research Centre, Room G54
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.