Applying for and maintaining a Clinical Trial Authorisation (CTA)

A Clinical Trial Authorisation (CTA) is the approval required from the MHRA before a Clinical Trial of an Investigational Medicinal Product (CTIMP) can begin in the UK.

The CTA submission package is prepared and submitted by the KHP-CTO Clinical Research Associate (CRA) in collaboration with Chief Investigator (CI) and research team as required.

This SOP describes the procedures for applying for and maintaining a Clinical Trial Authorisation (CTA).

This SOP applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations. and conducted in the United Kingdom