IRAS user guide

Once you've submitted your application its status will change to 'Pending regulator verification'. It will be validated within 3 days of being received and you'll be able to check the validation status in the dashboard. Validation will check whether all the required documents have been submitted, can be opened and are readable.

If your application is invalidated, an option will be available to resend the application. The option appears in the top right-hand corner of the main project page and can only be selected once. Selecting this option will create a new project with the same IRAS ID. You will have an opportunity to edit the application before it's resent to the regulator. This new project will have a notification appear at the top of the 'Project details' page confirming that it is a resend project.

When choosing to resend an application most user roles will be copied across to the new project (Project Deputy, Collaborators and Sponsor Group Organisations). If the resend project is created by the Chief Investigator (CI) then the CI details will also be copied over. In instances where the resend project is created by the PI, an ownership request will be sent to the CI.

Former question responses and uploaded documents will also be copied across. You'll need to confirm that all answers are still correct, by either selecting the 'Save and verify' or 'Update question set' options within each module.

The Sponsor or Sponsor Delegate will not need to accept their role again for the project, however they'll need to reconfirm the submission before it can be resent. Once ready, you'll be able to submit your application for authorisation as normal, and make a new REC booking.

You can withdraw an application as long as it has not been approved or received any Requests for Further Information (RFIs).

Once the status of the project (under My Projects) is 'Authorised' you will not have the option to withdraw the application. From 'My projects', select the IRAS ID of the project you wish to withdraw, select 'Withdraw' at the top right-hand corner and follow the instructions.

If you wish to resubmit a withdrawn application (or an application that was not authorised by the regulator) you'll need to navigate to the project and select the resubmit option. This option appears in the top right-hand corner of the main project page and can only be selected once. This will create a new project with the same IRAS ID and you will have an opportunity to edit the application before it's submitted to the regulator. This new project will have a notification appear at the top of the 'Project details' page confirming that it is a resubmission.

The process for resubmitting is similar to the process for resending (outlined above), but there are some key differences. When resubmitting an application, the user roles and documents will not be copied across to the new project, however your responses to questions will still appear. You'll need to confirm that these responses are still correct, by either selecting the 'Save and verify' or 'Update question set' options within each module.

Once ready you will be able to submit your application for authorisation and make a new REC booking.

Once you submit your project you may need to view or download documents, such as a copy of the submitted application or any letters added to the project by the regulator. Note that IMPD documents cannot be downloaded: this is a security feature to prevent users accessing sensitive data.

To download documents after submission, go to 'My projects' and select the project to open it. Scroll down to 'Project History'. Here you'll be able to access a list of all the actions taken on that project to date (initial submission, requests for further information, validation / acknowledgement, amendments etc). Select the action that the document you're looking for relates to. For example, if you're looking for an approval letter for a substantial amendment, locate and select that amendment in the 'Project History' list. You'll then reach a page with the information related to that amendment including the option to download a copy of the submitted amendment form (under 'System generated documents') and a copy of the approval letter (under 'Regulatory documents').

Example: downloading a copy of the initial application.

You may wish to do this for your records, or if you need to provide a copy to another organisation not included in the application. For example, as part of the Local Information Pack you would supply the 'Project Study Information' pdf.

To access the pdf:

• go to 'My projects' and select the project to open it
• scroll down to 'Project History' and select the P-code against the 'Initial submission' item
• on the next page scroll down to Project Documents - System generated documents. Here you can download each section of the application as a pdf. The Clinical Dataset is also available as XML