# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 3


The protocol for the proposed trial describing the objective, design, methodology, statistical considerations, purpose and organisation of the clinical trial.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/3/part/A1/paragraph/3 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-3/part-A1/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.