Clinical trials: Arrangements for trials which had an exemption or certificate on 1 May 2004

The following is to clarify the position with respect to existing clinical trials on 1 May 2004. On that day, the previous legislation covering clinical trials ended and was replaced by SI 2004/1031 which means that trials approved prior to 1 May 2004 are subject to the new requirements for pharmacovigilance, manufacturing/ importation etc. The legislation is not retrospective and applies only to activities performed since 1 May 2004. End of trial forms and reports are required for trials approved before 1 May 2004 which end after this date.

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.


Roll over to CTA
A letter was sent to all exemption holders (CTX, DDX or CTMP) and clinical trial certificate holders in March 2004 advising them of the arrangements to roll over current exemptions or certificates into clinical trial authorisations (CTAs).

Any trial which had a Clinical Trial Certificate (CTC) or Clinical Trial Exemption (CTX) or which had been notified under the Doctors and Dentists Exemption (DDX) scheme has, from May 1 2004, been treated as if it had a clinical trial authorisation (CTA). If your trial had these, you do not need to notify the MHRA. Where additional information is required as part of the roll-over arrangements, such as sponsor, it is accepted that, in some cases, this may not be available prior to 1 May 2004 but should be provided as soon as possible.

Change of Sponsor
Where the trial sponsor has changed since 1 May  2004, the Clinical Trials Unit should be advised as son as possible, if this has not already been done. A substantial amendment will be required and should be accompanied by the Notification of Amendment (Annex 2) form available on the EudraCT pages of the EMEA website (external link). No fee will be charged for this change.

Amendments or end of trial declarations for clinical trials that were originally CTX/DDX applications
As limited information was required at the time of application for Clinical Trial Exemption (CTX) and Doctor and Dentist Exemption (DDX) studies, we have been unable to process amendments or end of trial notifications to such studies electronically, resulting in delays to assessment and responses to sponsors. In order to remedy this situation and to ensure efficient processing of amendments to such trials, we ask that applicants fill out CT Form UK 1, provided below, and submit the completed form, with a completed Notification of Amendment form or Declaration of the end of a Clinical Trial form with the relevant data.

› CT Form UK 1 (61Kb)

Applicants only need to fill out CT Form UK 1 once for each trial (for the first amendment application made after 1st October 2007 or the end of trial declaration).

Contact for further information
All queries relating to submissions should be directed to: RIS.CT@mhra.gsi.gov.uk

For questions on the regulations contact: clintrialhelpline@mhra.gsi.gov.uk


Page last modified: 07 February 2008