5.4 Product information

As a prerequisite to planning the clinical trial, the sponsor is responsible for providing the investigator with available chemical/pharmaceutical, toxicological, pharmacological and clinical data (including data from previous and ongoing trials) regarding the investigational product and, where appropriate, the comparator product(s). This information should be accurate and adequate to justify the nature, scale and duration of the trial. In addition, the sponsor must bring any relevant new information arising during the trial to the attention of the investigator.

The sponsor is responsible for preparing and providing to investigators an Investigator’s brochure, which must include all relevant information about the product(s) and must be supplemented and/or updated whenever any relevant new information is available.