End of Study


The end of a study should be defined in your protocol e.g. last visit of last participant, completion of data collection.

All Studies (Except Clinical Trials of Investigational Medicinal Products)

 

 The Link opens in new windowNRES Declaration of End of Project Form (for non-CTIMPS) should be submitted to the main Research Ethics Committee (REC) that approved the study within 90 days of the end of the project. If the project has terminated prematurely, the form should be submitted within 15 days. Copies of these forms should be sent to the NHS Grampian R&D Office.

 

An End of Study Report may be enclosed with the end of study declaration or sent at a later date. However, a report must be submitted within 12 months of the end of the project. A template form is not available from NRES but the report should include:

  • whether the objectives were achieved
  • the main findings
  • the arrangements for publication or dissemination of the research.
A copy of the final report should be forwarded to NHS Grampian R&D Office.

 

Clinical Trials of Investigational Medicinal Products (IMPs)

 
It is a legal requirement of the current regulations that the competent authority and the main REC is notified that the clinical trial has ended. For studies sponsored by NHS Grampian and the University of Aberdeen this responsibility is delegated to the Chief Investigator (CI).
 
At the end of the trial, as specified in the protocol, the CI must complete the Link opens in new windowDeclaration of the end of a clinical trial form and submit it, within 90 days of the end of the trial, to: 
  • Main REC
  • NHS Grampian R&D Office
  • MHRA (MHRA will acknowledge receipt of the End of Trial Declaration) 
 
The CI is also responsible for submitting an End of Study Report, to the afore mentioned departments, within 12 months of the end of the trial. As noted above, the report should include, whether the objectives were achieved, the main findings and the arrangements for publication or dissemination of the research.

Dissemination

 
Health and community care research is conducted for the benefit of patients, users, care professionals, and the public in general.
 
The Research Governance Framework states 'All those conducting research must open their work to critical review through the accepted scientific and professional channels. Once established, findings must be made accessible to those participating (including the relatives of deceased patients who have consented to the use of organs or tissues in the research) and to all those who could benefit from them. This may be through publication and/or other means appropriate to the type of research'.
 
Dissemination strategies for the research community should include publication in scientific journals, presentation at local, regional, national and if appropriate, international conferences and meetings.
 

Informing Participants

 

All participants should be notified when their involvement in a study is complete. The dissemination of the study's outcomes to participants must be followed as described in the approved protocol and research ethics application. Research involving human participants can only be achieved with the agreement and cooperation of the participants and therefore researchers have an obligation to inform them of the research findings. Strategies for informing participants and the wider community of research findings require to be different to scientific dissemination and should be presented in an appropriate format and in lay terms. Possible routes for dissemination are through newspaper articles, support group websites or leaflets in waiting rooms. Disseminating information may also promote research participation and demonstrate how research can improve clinical care.