Investigator Brochure

Investigator Brochure summarizes the relevant to non-clinical and clinical studies data about an investigational product (IP). It includes information regarding IP used in previous non-clinical and clinical studies so that the study investigator and others can have the best guidance. In other words, IB is the compilation of the clinical and nonclinical data on the investigational product relevant to the study of the same product in human subjects. Its purpose is to provide clear information like dose, dose regime, route of administration, known adverse events, and possible drug side effects. This information facilitates safety monitoring in the current study. It provides insight to support the clinical management of the study subjects during the course of the clinical trial. It informs the investigator about the risks and benefits of investigator product know till the day, so that during the study, if any challenge comes up, they can take guidance from IB.

For instance, IB of phase III trial will include all information of testing of the drug on animals (pre-clinical), results of phase I and II studies, hence now for phase III study, investigator and team know about followings in advance:

  • How the new drug will behave, as they have results of previous studies in hand
  • What are the possible risks and benefits?
  • Known adverse events,
  • Number of expected serious adverse events and
  • Any other challenge