What should be included in an Investigator’s Brochures
Section 7 of International Council Harmonisation E6: Guideline for Good Clinical Practice (GCP) is an internationally recognised, ethical, and scientific quality standard for conducting and reporting drug trials.
GCP states that an Investigator’s Brochure should be produced when a drug’s development reaches the time to conduct the first clinical study in humans. Regarded as a living document, the brochure requires updates as work progresses and new information becomes available.
Updates should be made at least once a year, including new data on the characteristics of the new product, especially anything relating to safety. This should lead to a further assessment of the benefits and risks.
Regarding the structure of the Investigator’s Brochure the highest level sections should include:
- Physical, chemical, and pharmaceutical properties and formulation
- Non-clinical studies
- Effects in humans
- Summary of data and guidance for the Investigator