CTIMP Research CTIMPs are regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004 The regulations are derived from European Directive 2001/20/EC, which outlines how clinical trials in the EU should be conducted The regulations apply to CTIMPs undertaken across the UK Schedule 1, Part 5 of the regulations outlines the special requirements for CTIMPs involving adults LCC to proceed These requirements place a higher threshold for authorisation than the comparable requirements in the Mental Capacity Act
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