Forms for clinical trials

From 1 November 2007, letters from the MHRA relating to clinical trial submissions will not be signed. The wording and format of letters from the MHRA relating to clinical trial submissions will also be modified from this date. This is in line with MHRA policy.

Initial application
To complete the Clinical Trial Application form, save it as an XML file and obtain a EudraCT number you need to access the EudraCT pages of the EMEA website (external link).

A checklist of information to append to the application form: Section J (Formerly Section K) (external link).

Amendments
To apply to make an amendment to a trial for which you already have approval, please use the Notification of Amendment (Annex 2) form available on the EudraCT pages of the EMEA website (external link).

End of trial declarations
To tell us that a trial has ended, please use the Declaration of the end of a Clinical Trial form available on the EudraCT pages of the EMEA website (external link).

Amendments or end of trial declarations for clinical trials that were originally CTX/DDX applications
For amendments or end of trial declarations to clinical trials that were originally CTX/DDX application, we ask that in addition to the Notification of Amendment (Annex 2) form, applicants fill out CT Form UK 1 (61Kb). .

Manufacturer’s authorisation
An application form for a MA(IMP) and guidance notes for completing the form are available below:
› Application form for a manufacturer's authorisation for investigational medicinal products (MA(IMP)) (770Kb) 

To order a hard copy of the Department of Health and MHRA Register of Holders of  Manufacturer’s Authorisations for Investigational Medicinal Products (MAIMP) 2007 register, please complete the order form (116Kb).

QP Declaration
Where the manufacturing site is outside the EU or EEA, then a Qualified Person (QP) must certify that the overseas manufacturing site operates in accordance with standards equivalent to EU GMP by filling in the QP declaration form:
› Qualified Person declaration concerning investigational medicinal products manufactured in third countries (27Kb) 

Reporting SUSARs
SUSARs should be reported using a CIOMS 1 form (external link).