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IRAS user guide

  • Getting started
  • Create your project and initial application
  • During your research
  • End of research
Amendments Adding new sites Updating project information Reporting during research Developmental Safety Update Reports Reassigning roles Downloading documents
  1. During your research
  2. Downloading documents

Downloading documents

Once an application has been submitted, you may need to view or download documents such as a copy of a submitted application, or access a letter that has been uploaded to the project by the regulator.

To locate and download documents relating to a previously submitted study you should follow this process.

  1. Go to 'My projects' and select the relevant project to open it. If you have a large number of projects you can use the search function at the top of the page to find a specific project.
  2. You'll then be taken to the 'Project Overview' page for that project. Here you should scroll down to the very bottom of the page where a section titled 'Project History' will be located.
  3. The project history section will have a table that lists all the actions taken on that project to date (for example the initial submission, MHRA validation / acknowledgement, amendments submitted). In the table locate the relevant action that the documents you're looking to download relates to and select the corresponding link under the 'ID' column in the table.
  4. On the next screen scroll down and select the 'Project documents' section. There you'll be able to see all documents that relate to action you've submitted and links on the right-hand side for you to download a copy of any available documents.

As an example, if you're looking for an approval letter for a substantial amendment, then you should select the project, scroll down to 'Project history' and locate the relevant amendment you need the approval letter for. You should then select the corresponding link under the 'ID' column of the table for that amendment. This will take you to an overview page for that amendment where if you select the 'Project documents' section you will be able to download a copy of the approval letter (under 'regulatory documents').

Downloading documents submitted in response to a request for further information

For some applications after the initial review the sponsor will have received a request for further information (RFI) from the MHRA or REC after the initial review of their application. This could include asking the sponsor to submit an updated dataset in new IRAS or new documents.

If this happened for a study and you need to locate documents that were submitted after the RFI then you should follow steps 1 and 2 in the above process. Under the 'Project History' section you should look through the table and locate the 'initial outcome' entry, however rather than select the corresponding link under the ID column you should instead select the arrow icon next to the ID link.

This will expand this entry and if you scroll down further you will see another table with an 'ID link' for the RFI issued for the application. Selecting this link will take you to a page where you can see and download the documents submitted in response to the RFI, including the updated dataset and any updated documents.