1. The sponsor shall provide the investigator with the investigator's brochure.
2. The investigator's brochure shall be updated where new and relevant safety information becomes available, and shall be reviewed by the sponsor at least once per year.
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Chapter VIII · CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS › Article 55
Investigator's brochure
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