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"Further, while we acknowledge the corrective and preventive actions that your site has taken or plans to take, your written response is inadequate because it does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of the study procedures (for example, adherence to eligibility requirements)

De Minicis, S

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Current NICE technology appraisals and the relevant UK Summaries of Product Characteristics (SmPCs), available via the Electronic Medicines Compendium (EMC), provide authoritative guidance on indications and eligibility