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.
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