Clinical Trial Management

A Clinical Trial of an Investigational Medicinal Product (CTIMP) is defined in the Medicines for Human Use (Clinical Trial) Regulations 2004 as:

“Any investigation in human subjects, other than a non-interventional trial, intended to discover or verify the clinical, pharmacological, or other pharmacodynamic effects of one or more medicinal products, or to identify any adverse reactions to one or more such products, or to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products.”

A CTIMP cannot open at site until:

• Authorisation is granted by the MHRA (Medicines and Healthcare products Regulatory Agency)
• Approvals from the Health Research Authority (HRA) and NHS Research Ethics Committee (REC) have been granted
• The research site has confirmed C&C and received the sponsor ‘green light’ to begin recruitment

All CTIMPs require a Sponsor who takes responsibility for all aspects of the trial. If you are planning to carry out a CTIMP and would like to discuss CNTW sponsorship, then please email [email protected]