An Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data of an investigational product relevant to the study of this product in human subjects. Its purpose is to provide the investigator and others involved in the trial with understanding of the rationale for, and assure their compliance with, key features of the protocol (such as dose, frequency/interval, methods of administration, and safety monitoring procedures). Based on this information, the investigator can make an unbiased risk-benefit assessment of the appropriateness of the proposed trial.
The type and extent of information included in the IB will vary with the stage of development. The majority of information concerns preclinical data in early development and clinical data in later development. The IB will also include a Reference Safety Information section providing a list of expected serious adverse reactions for regulatory reporting purposes.
The IB needs to be updated when relevant new information becomes available. The IB shall be reviewed at least once per year and revised as necessary in compliance with a sponsor’s written procedures. More frequent revisions may be appropriate depending on the stage of development and the generation of relevant new information (eg, findings from recent studies). Important relevant new information should be communicated to the investigators, and possibly to the IECs/IRBs and/or regulatory authorities before it is included in a revised IB (by means of an IB addendum).
The IB is a multidisciplinary document involving a wide range of functions that provide input or contributions for several sections. Consequently, logistical challenges may occur during the IB writing process.
The Medical Writer can play an important role in the document development process (eg, compile contributions, circulate for review, implement comments). If applicable, the Medical Writer can also help to draft one or more sections (mostly clinical), suggest ways to reduce content, and revise the text for consistency.