Posted Fri, 14 Feb 2025 21:19:56 GMT by Brian Caselli
Hello, I am wondering if it is possible for multiple users from two different organizations to have access to the same application (in this case an Orphan Drug Designation request). My company is working with a CRO to complete the submission through IRIS however I also have IRIS administrator and manager roles for my organization (we are the sponsor of the ODD application). Can the CRO who is creating the submission on our behalf also add me to the submission so I am able to see it and follow the process in IRIS as it is reviewed?
Posted Sun, 16 Feb 2025 10:04:40 GMT by Paolo Tomasi EMA
IRIS works on a system of affiliation to organisations, which is not linked to any contractual relationship of IRIS users with any particular organisation. Affiliation is under the control of the organisations, each of which has to nominate an initial "Admin User", in charge of allowing future affiliations. In this particular case, you can be added to the submission as a contributor or manager for that submission if you are also affiliated to the CRO in question, with an IRIS role, in addition to the company where you already have an IRIS affiliation and role.  

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