This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Investigator’s Brochure
Investigator’s Brochure
Investigators need to be provided with information about the investigational medicinal product (IMP) data, in order to facilitate their understanding of the rationale for, and their compliance with, key features of a clinical trial protocol.
Investigator’s Brochure
The investigator’s brochure compiles the current IMP data of relevance for the clinical trial investigators.
IB in the European Union
The IB compiles a brief summary of the IMP quality, as well as the nonclinical data and clinical data of the IMP which are relevant for the investigators who participate in a clinical trial involving the concerned IMP. The IB should also include a dedicated section for the reference safety information, which informs the investigator of the IMP safety profile and is used by the sponsor to determine the expectedness of adverse reactions observed in the clinical trial. The IB is part of the clinical trial application to the competent authorities and ethics committee and must be approved before the clinical trial can start. The IB must be updated at least once a year.
IB in the US
Investigators may obtain Investigator’s Brochure (IB) from IND product’s manufacturer. For investigator-initiated IND applications that have a right of reference to an existing manufacturer’s IND application, submission of the IB is not required. IB is updated as the development program progresses, and new information becomes available. IB is expected to contain the following information:
- Brief description of the drug substance and the formulation, including the structural formula, if known
- Summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans
- Summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans
- Summary of information relating to safety and effectiveness in humans obtained from prior clinical studies
- Description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug. Adverse Events (AEs) described in the IB help determine whether an AE that occurs during a clinical trial is “expected” and, if so, how it will be reported to FDA.