Provision of IMP related documents:
- preparation and review of IMP sections in trial protocols
- preparation of a full or abbreviated Investigational Medicinal Product Dossier (IMPD)
- IMP guidance section of Investigator’s Brochure (IB)
- manufacturing documentation – e.g., Certificate of Compliance,
- generation of randomization list / unblinding list
- Code Breaking Cards (CBC) / Randomization Envelopes
- IMP batch release by QP in accordance with Directive 2001/20/EC
- QP statements related to imported IMP are prepared based on audits of the manufacturer’s production site(s)
IMP documentation respects the interface between Good Manufacturing.