How do I link kit codes to IMP?

Codes are written or printed on the packaging of the Investigational Medicinal Product (IMP) you give to trial participants. This is usually done either by the trial pharmacies or a specialist drug packaging company. Obviously these parties will need to be unblinded and require a copy of the code list to do this.

If the codes are pre-printed on the kits, you will need to allocate different parts of the code list to different trial sites. You will need to update the randomisation system with this information to ensure the code allocated is available on site when randomising a patient. Conversely, if pharmacies hold unblinded stocks of the trial IMP a pharmacist can write the kit code on the packaging at randomisation. In this case there is no need to allocate different parts of the code list to different trial sites in advance.