Authorisations
Rather than using electronic signatures, Sponsors and Chief Investigators will 'authorise' an application in the system by completing key tasks as described below.
Chief Investigators (CI)
The CI confirms their agreement to take responsibility for the application and undertake all CI duties either when they
- create a new project and identify themselves as CI, or
- accept the role of CI for a project sent to them by the Project Deputy
It will not be possible to submit an application until the CI has accepted the project by one of these methods.
Sponsors
When a Sponsor or Sponsor Delegate receives a task to review a project (under 'My Tasks' - 'My Organisational Tasks') they can review the completed dataset and if happy with it, check the radio button labelled 'I confirm this submission', followed by the 'Submit' button.
There is no separate declaration statement in the system. This confirmation is equivalent to the following declaration: 'I hereby confirm that / confirm on behalf of the sponsor (delete which is not applicable) that:
- the information provided is complete
- the attached documents contain an accurate account of the information available
- the clinical trial will be conducted in accordance with the protocol
- the clinical trial will be conducted, and SUSARs and result-related information will be reported, in accordance with the applicable legislation.'
If the Sponsor or Sponsor Delegate Organisation reviews the application and wishes to request changes, they should select 'I do not confirm this submission'. They can then provide details of the changes required in the 'Reason for not confirming' box. Selecting the submit button will then transfer the application back to the user who sent the request. That user will now have an active task to edit the project information as necessary.