NIHR Clincial Trials Toolkit


The positioning of stations along the routemap describe critical paths and process flows and covers all aspects of the research life cycle, from study planning through to dissemination and archiving. The routemap uses symbol and colour coding to distinguish between legal and good practice requirements, and to indicate which aspects of these are relevant to wider clinical research. Each station provides a topic overview as well as additional links to more detailed information or other relevant stations.


The NIHR Clinical Trials Toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) with specific reference to the current regulatory requirements set out by the European Commission Directive 2001/20/EC. However it also contains much that is of relevance to the wider trials environment.

Click the image below to access the NIHR Clinical Trials Toolkit

NIHR Clinical Trials Routemap