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During your research project

Once your project has been approved you will need to keep the relevant review bodies informed. This section covers the various issues you might need to consider whilst you are conducting your study. Use the menu on the left to see the pages in this section. The next section covers the areas to consider at the end of your study.

The Approval Conditions for CTIMP studies or the Approval Conditions for non-CTIMP studies will be sent to you along with a copy of the favourable opinion letter from the Research Ethics Committee. Separate Approval Conditions exist for Research Tissue Banks and Research Databases.

Progress of the research

This section explains:

  • when you need to send updates on your project
  • who you need to send the reports to

 

Amendments – changes to the protocol and other approved information

This section covers:

  • definitions of substantial and non-substantial amendments
  • preparing amendments
  • which review bodies need to approve or be notified of which types of amendments

 

Safety information

This section explains:

  • which incidents need to be reported to regulatory bodies, and the specific timeframes.
  • what regular reports on safety need to be provided during your study

 

Preparing for the end of the study

This section covers the arrangements you will need to put in place for the end of the study.