The investigator or institution is responsible for investigational product accountability, handling, dispensing, administration and return, which may be delegated to a pharmacist or other person under oversight proportionate to the product's characteristics, administration complexity, existing safety knowledge and marketing status, with the sponsor able to facilitate (for example forms, systems or direct distribution). Records should cover delivery, inventory, use by each participant (including confirmation of protocol doses), and its return to the sponsor, destruction or other disposal, with dates, quantities, batch or serial numbers, expiry dates and product and participant codes (alternatives possible for authorised products). Products should be stored as the sponsor specifies and regulation requires, used only under the approved protocol, explained to participants with periodic checks on correct use, and, where shipped to participants or dispensed nearby and administered at home, managed with safeguards for integrity, protocol use and safety. The investigator should follow randomisation procedures, break the code only as the protocol allows, be ready from the start to unblind quickly in an emergency, and promptly document and explain any premature unblinding to the sponsor.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.