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How to Declare the End of a Study
The end of the trial is normally defined as the last visit of the last participant, unless otherwise specified in the protocol. There are different processes to go through depending on whether you are undertaking a Clinical Trial of Investigational Medicinal Products or undertaking any other research.
Guidance for Clinical Trials of Investigational Medicinal Products
Guidance
for All Other Research
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Guidance for Clinical Trials of Investigational Medicinal Products
Definition of End of Trial
The end of the clinical trial must be formally defined in the research protocol for the CTIMP.
Who is responsible for notifying the Competent Authority of the end of the trial?
It is a legal requirement of the current regulations that the competent authority and Main REC is notified that the clinical trial has ended. For CTIMPs being sponsored by one of the above organisations, this responsibility is delegated by the Sponsor to the Chief Investigator for the clinical trial.
Process for Notification of the End of the Trial
At the end of the trial, as defined in the protocol, the Chief Investigator must complete the MHRA Annex 3 document <<enter web link CTT11>> . The following information must be provided:
- Name and address of sponsor or his legal representative in the Member State
- Title of the trial
- EudraCT Number
- Sponsor's protocol number
- Date of end of the trial in the Member State concerned
- Date
The completed Annex 3 document must be sent within 90 days of the end of the trial to:
| Regulatory Authority: | Clinical Trials Unit Medicines and Healthcare Products Regulatory Agency Market Towers 1 Nine Elms Lane Vauxhall :London SW8 5NQ |
| Sponsor: | FAO Quality Assurance Department |
| Main REC: | Trial Specific contact details |
Suspension of Termination of a Clinical Trial
Where a clinical trial is suspended or terminated early, upon the advice of the Sponsor, Chief Investigator, provider of the IMP or independent monitoring committee the Chief Investigator is responsible for notifying the Main REC and MHRA. The Chief Investigator must notify the Sponsor immediately of the need for the trial to be suspended or terminated early, with full reasons why the decision has been made, unless the decision has been made by the sponsor.
Where the Regulatory Authority requires a clinical trial, or trial site to be closed the notice of suspension or termination will be served to the Sponsor for the trial. The Sponsor will notify the Chief Investigator immediately that such a notice is served. The Chief Investigator must suspend or terminate the trial after discussing the implications for and further treatment for any patients in the trial
Clinical Trial Report
The Chief Investigator is responsible for submitting the Clinical Trial Report to the MHRA no later than 1 year after the end of the trial. See LTHT/UoL Guidance Document entitled ‘Writing a Clinical Trial Report' <<enter web link CTGN26>> and Template <<enter web link CTT19>>
Guidance for All Other Research
For all research studies other than Clinical Trials of Investigational Medicinal Products, it is the responsibility of the Chief Investigator to notify the REC that gave a favourable opinion of the research (the ‘main REC'), the Sponsor and R&D of the end of the study.
The end of the study is defined as the final date or event specified in the protocol, not the completion of data analysis or publication of the results.
The following COREC form should be used:
Declaration
of the end of a study 
The Chief Investigator should complete this form and send it to:
-
Main REC that provided a favourable opinion – REC contact details
-
Research Sponsor – where LTHT/UoL is the sponsor, please send documentation to the R&D Department
- R&D Department - if the Trust or University is not the Sponsor, please send the report to the R&D Department