e-Pathway: Project End

Investigator site closure is the process of ensuring all project-related activities are reconciled and/or complete. Site closure activities are documented in the site close out report. 

Please refer to the UoB Investigator Site Management SOP (UoB-SMA-SOP-001) (Word - 317 KB) for further information. This SOP describes the procedures involved in the set-up, initiation and closure of investigator sites.

Once data collection has been completed and before statistical analysis begins the appropriate data quality checks need to be performed and the database locked to ensure integrity is maintained.  

There may be instances where unlocking the database is required, however strict processes must be in place to manage such a scenario and to ensure there is transparency around any changes made.  

More information on the processes surrounding database cleaning and locking can be found in the UoB Data Management SOP (UoB-DMA-SOP-001) (Word - 732 KB). 

The analysis of the resultant data and reporting must be scientifically sound in order to ensure that the results are reliable, minimise bias, and address the research question.  

The UoB Statistics SOP (UoB-STA-SOP-001) (Word - 137KB) provides further information about the development of the statistical analysis plan (SAP) and the performance of interim analyses and the final analyses.

When a project has finished, the relevant regulatory authorities should be informed of the project closure. 

Further information can be found in the UoB Project Closure SOP (UoB-CLO-SOP-001) (Word - 77 KB).

All research which has been reviewed by a Research Ethics Committee should submit an end of project declaration form to the REC and sponsor once the project has finished. For further information, see the ending your project page of the HRA website.

For clinical trials of investigational medicinal products or medical devices the end of trial declaration will also need to be submitted to the MHRA. More information is available on the clinical trial management page of the UK government website.

There may be a requirement to inform the funder or any third parties once a project has closed depending on any agreements in place.  

For projects that have collected human tissue samples, sample analysis should be completed prior to declaring the end of the project. Further information on the handling and processing of samples once a project is due to close can be found in the UoB Project Closure SOP (UoB-CLO-SOP-001) (Word - 77 KB). See also the accordion titled 'Tissue Management'.

If you require further time to complete the project or to carry out further analysis, an extension to the planned end date of the project may be required through a project amendment. Please contact researchgovernance@contacts.bham.ac.uk in this instance. 

At the end of a clinical research project the data and other essential material that would allow for reconstruction of the research project must be stored securely and readily available for inspection. The minimum amount of time that the material must be stored for at UoB is 10 years, however if you are doing certain types of projects, such as a clinical trial of an investigational medicinal product, then the period you need to archive for will be longer. It is important to know how long you need to archive material for before you start your project, so that potential costs and resources for this can be factored in early on.  

Guidance on the archiving periods for different types of research project can be found in the Guide to Retention Times document (UoB-ARC-QCD-003) (Word, 104 KB). See also the UoB Archiving SOP (UoB-ARC-SOP-001) (Word – 198 KB) for full details on the UoB archiving requirements for clinical research.

If you have residual tissue samples left over once your research project has ended, you have several options as to what you can do with them. These options include applying for further ethical approval to use the samples in another project, transferring the samples into a facility that holds a human tissue license, or disposing of the samples appropriately. Further information about all these options can be found in the Laboratory & Human Tissue section of the CRCT FAQ webpage.

The clinical research e-Pathway provides a roadmap to the various stages and sub-stages that a researcher may follow during the lifetime of their research project. Click on a link to take yourself to the stage that is of interest, or you can use the roadmap image on each page to navigate through the process.  

From Idea to Proposal

Applying for Funding

Project Setup

• Governance & Ethics
• Essential Documents
• Human Tissue & Data

Green Light - Ready to Go?

Project Management

• Quality & Oversight
• Adverse Events & Deviations
• Amendments

Project End (current page)

• Maximising Impact

Need help with your project? See the 'who can help?' section. 

For an overview of the e-Pathway, return to the homepage.