The IB compiles the clinical and nonclinical data relevant to studying the product in people, so investigators understand and follow key protocol features such as dose, frequency, administration and safety monitoring. The sponsor generally ensures an up-to-date IB (sponsor-investigators check for one from the marketing authorisation holder or supply the information); where regulators allow, current product information such as the SmPC may substitute if comprehensive; a new indication for an authorised product generally needs its own IB. Review of the IB should happen at least yearly and revised as needed under documented procedures, with important new information sent to investigators (and possibly IRBs/IECs and regulators) before the revision. Its reference safety information, listing adverse reactions with frequency and nature, is the reference for judging expectedness and expedited SUSAR reporting. The content should be brief, plain, objective, balanced and free of promotion so clinicians can make their own risk-benefit judgement, with a medically qualified person involved and each section signed off by the discipline that produced its data, covering at least a title page, confidentiality statement, contents, summary, introduction, the product's physical, chemical and pharmaceutical properties and its formulation, nonclinical studies, effects in humans and a summary of data and guidance for the investigator.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.