To use IRIS, you need to have been granted at least one of the following affiliation roles for the organisation on whose behalf you will be acting:
A) Scientific procedures (e.g. for Inspections, Scientific Advice, Orphan Designation or Innovation Task Force briefing meeting)
Individual role:
- IRIS Individual User: this role is assigned automatically by system for new accounts, or approved automatically. You should use this role if you will be submitting applications as an individual user, not on behalf of an organisation.
Affiliated roles:
- IRIS Industry User Admin: can assign the other roles to those who request then for the organisation. Please note that an Industry User Admin cannot access IRIS, or create submission, unless the User also gives himself the role of Industry Manager (below).
- IRIS Industry Manager: can create new applications, and edit, submit and withdraw the created applications or any other where the user has been specifically added as Industry Manager.
- IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit submissions where he/she has been added as a Contributor by a Manager. An Industry Contributor cannot create, submit or withdraw a submission.
- IRIS Industry Coordinator : users with this role can access any submission/application made on behalf of an organisation, and not only those where the user is the creator or has been added as a manager/contributor, with the functions of IRIS Industry Manager. Please note that this role does NOT allow to create new submissions of any kind: for that, it is necessary to also have the role of Industry Manager, for the same organisation.
B) Parallel Distribution procedures
Affiliated roles
- IRIS Parallel Distribution User Admin: can assign the other roles to those who request then for the organisation. Please note that an Industry User Admin cannot access IRIS, or create submission, unless the User also gives himself the role of Industry Manager (below).
- IRIS Parallel Distribution Manager: can create, edit, submit and withdraw applications.
- IRIS Parallel Distribution Contributor: can edit applications (but not create, submit or withdraw them)
Additional information on what individual roles can see in the system is included in the
IRIS guide to registration.