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Release of Clinical Checklist to Industry

The New Drugs Committee (NDC) Clinical Checklist forms part of the paperwork that is provided to NDC and SMC members in advance of meetings. The clinical checklist is a working document that is used by the pharmacy reviewer for summarising the main points of the manufacturer’s clinical submission and for highlighting the key strengths and weaknesses of the case presented. Consideration of all the information recorded on the checklist allows the pharmacy reviewer to come to a judgement on the quality of the clinical studies presented and the generalisability to the Scottish population.
This clinical checklist is provided to the manufacturer, in confidence, for information purposes only and will be released on the same day as the SMC advice is provided to the manufacturer. Publication of the checklist, or parts thereof, is prohibited. 
In accordance with the Data Protection Act 1998 and any other applicable data protection legislation, all personal information has been removed from the checklist prior to release to the manufacturer.