The sponsor should make sure an IB exists and is updated when significant new information emerges or, for authorised products, name the basic product information that will be used. Investigational products, including comparators and placebo, should be characterised for their development stage, made under applicable GMP, coded and labelled to protect blinding and labelled to regulation. The sponsor should set storage temperatures and conditions, shelf life, reconstitution fluids and procedures and administration devices and tell everyone involved; package products to prevent contamination and deterioration in transport and storage; in blinded trials, run a process to blind the relevant people and prevent and detect improper unblinding, a mechanism for rapid emergency identification of a participant's product without revealing others', and a way to keep the trial blind when a participant is unblinded for safety reporting; and, for significant formulation changes, have results of studies such as stability, dissolution or bioavailability available before the new formulation is used.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.