Voisin Consulting Life Sciences glossary icon

Investigator’s Brochure

Click a letter to view all its definitions

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.

Other glossary definitions


GDPR / General Data Protection Regulation

The General Data Protection Regulation 2016/679 or GDPR came into effect in 2018 and sets…

View definition

Data Protection Officer (DPO)

The primary role of the DPO is to ensure that his organization processes the personal…

View definition