# The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, Regulation 4: Insertion of regulation 3A of the principal Regulations


After regulation 3 of the principal Regulations (sponsor of a clinical trial) insert the following regulation—
“Sponsor’s responsibility for the investigator’s brochure
3A 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.”.

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Source: https://www.legislation.gov.uk/uksi/2006/1928/regulation/4 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.