# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 3A: Sponsor’s responsibility for the investigator’s brochure


The sponsor of a clinical trial shall—
(a) ensure that the investigator’s brochure for that trial, and any update of that brochure, presents the information it contains in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial; and
(b) validate and update the investigator’s brochure at least once a year.

---
Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/3A (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-3A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.