Clinical Trial of an Investigational Medicinal Product (CTIMP)

The amount of information we require about CTIMPs for governance depends on which organisation (or individual) is taking responsibility for the work (i.e.  is willing and able to fulfil the role of Sponsor). For drug trials (CTIMPs), this is often a commercial company which contracts with the University to conduct the trial. Research & Innovation Services Contract Officers can help with guidance.

CTIMPs (drug trials), as defined in the European Clinical Trials Directive 2001/20/EC, have been governed by UK law since 1st May 2004 by virtue of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031, amended 2006).

Information, essential elements and forms

Guidelines

Protocol

Insurance certificate (commercial trials only)

Participant Information sheet

MHRA approval letter

Consent form

 

IRAS application 

 

Data Retention Information

 

 

Guidelines for completing sections A76/77 of NRES applications