Generally, the sponsor is responsible for ensuring that an up-to-date IB is developed. In the case of an investigator-initiated trial, the sponsor-investigator should determine whether a brochure is available from the product license/marketing authorisation holder. If the investigational product is provided by the sponsor-investigator, then they should provide the necessary information to the investigator site staff. Where permitted by regulatory authorities, the current scientific information such as a basic product information brochure (e.g., summary of product characteristics package leaflet, or labelling) may be an appropriate alternative, provided that it includes current, comprehensive and detailed information on all aspects of the investigational product that might be of importance to the investigator. If an authorised medicinal product is being studied for a new use (i.e., a new indication), an IB specific to that new use should be prepared unless there is a rationale for only one IB. The IB should be reviewed at least annually and revised as necessary in compliance with a sponsor’s documented procedures. More frequent revision may be appropriate depending on the stage of development and the generation of relevant new information. Relevant new information may be so important that it needs to be communicated to the investigators and possibly to the institutional review boards/independent ethics committees (IRBs/IECs) and/or regulatory authorities before it is included in a revised IB.