After the study

When your study is complete, there are a number of things which you will need to do to formally end the study, including sending various documents to the Research Governance team and the Research Ethics Committee which approved the study.

Guidance from the HRA about the considerations which apply at the end of a study, along with information on the forms which may need to be submitted, is available on the 'Ending your project' page of the HRA website.

In particular, you will need to submit the following:

• An End of Study declaration form should be submitted both to the to the Research Ethics Committee and to the Research Governance team via researchgovernance@contacts.bham.ac.uk.  The form, along with guidance on how to complete it, can be found in the 'Declaring the end of a study' section of the HRA web page.
• For CTIMPs, you should also notify the MHRA as outlined in the 'Notifying the MHRA' section of the same web page.
• In line with the HRA guidelines on research transparency and the principles of the UK Policy Framework for Heath and Social Care Research, within a year of the end of the study, the results of the research should be made public.  Guidance on doing so is available on the 'Making results public' webpage.
• Publications must be listed on the University's PURE system
• The Research Governance team can also help with study registration on publicly accessible research databases and upload of results.  For further information on study registration, see the UoB Position Paper on Clinical Research Registration (.pdf - 219KB).

You will then need to archive your study documents and data. This should include the data you have collected and any tools or documents needed to reproduce the study results from those data. It should be possible for someone looking at your archived material to reconstruct what you did on the study in detail and validate your results. Further information for clinical trials, including the University's Archiving SOP, is available on the QMS web page.

You need to ensure that all data and documents are secured and stored in line with University policies.  For further information, please see our Guidance on UoB Research Data Management policies.