Roles in the system
As an IRAS user you can give, and be given, different roles and tasks, either related to a specific project or related to an organisation account. It is important to remember that as an IRAS user you may have one or more of these roles.
These roles mean that more than one person can have access to, and manage, a project at the same time. People from different teams or organisations can work on the project without the need to transfer it between users.
All projects must have a Project Deputy and Chief Investigator assigned. This ensures there are always two individuals with access to the study and supports business continuity.
When adding an individual to a project, either as Chief Investigator, Project Deputy or Collaborator, start typing their email into the relevant field and then select it from the menu. If their email does not appear it means they do not have an account set up in IRAS or they have an account set up under a different email address - in this case you'll need to contact them to check that they have an account and confirm the username.
Each section below provides more information on each of the roles in the system:
This is the investigator with overall responsibility for the research. In a multi-site study, the CI has co-ordinating responsibility for research at all sites.
Within IRAS, the CI is responsible for the tasks below. However, they may choose to assign some of these to the Project Deputy.
A CI must be assigned to the project. They will need to accept the project (and accept amendments to change the CI if this crops up in the future). It will not be possible to proceed to submission unless a CI is assigned and has accepted the project in IRAS.
Key tasks a CI may perform in IRAS are:
- creating an IRAS project
- accepting ownership of an IRAS Project (this must be completed before the project can be submitted)
- adding a Project Deputy
- adding a Sponsor or Sponsor Delegate organisation to the project in IRAS
- selecting study collaborators
- completing IRAS question sets
- uploading study documents
- forwarding the application to the Sponsor or Sponsor Delegate Organisation for review andsign off
- REC booking
- receiving, reviewing and answering Requests for Further Information (RFI)
- creating a new amendment
- creating a new report
- updating the Project Deputy role, as required
- submitting final reports
Project Deputy is a new role within the system and has been added to allow for different ways of working between organisations. It means that in addition to the CI, the Project Deputy can have access to edit a project, and allows certain tasks traditionally undertaken by the CI to be assigned to the Project Deputy. For commercially-sponsored studies the Project Deputy will usually be the person from the company who is preparing the application in IRAS. For non-commercial research the Project Deputy will usually be a trial manager or research nurse.
The Project Deputy role is not a new research role, the term is only used to describe a type of IRAS user.
The Project Deputy should be a named person using their own individual IRAS account. The system is not designed to support the use of joint or shared accounts. The Project Deputy will only have access to the studies that they are allocated to. This role does not have access to other studies in the CI's portfolio.
There can only be one Project Deputy per project.
If required, the Project Deputy or Chief Investigator can reassign the Project Deputy role to another user. For instructions on how to do this visit the section of this guide on Reassigning roles.
Key tasks a Project Deputy may perform in IRAS are:
- creating an IRAS project
- accepting Project Deputy role of an IRAS Project
- inviting a CI to access the project in IRAS
- adding a Sponsor or Sponsor Delegate organisation to the project in IRAS
- adding study collaborators
- completing IRAS question sets (only if determined by the sponsor/CI to have relevant training and experience)
- uploading study documents
- forwarding the application to the Sponsor or Sponsor Delegate Organisation for review and sign off
- REC booking
- receiving, reviewing and answering Requests for Further Information (RFI) (only if determined by the sponsor/CI to have relevant training and experience)
- creating a new amendment
- creating a new report
- updating the CI role
- may also undertake a separate role as a Sponsor Group Organisation contact if appropriate
- submitting final reports
The Collaborator role allows any other appropriate member of the research team to have access to the project in IRAS. There can be as many 'Collaborators' added to a project as required. The option to 'Add collaborator' appears on the project dashboard, under the 'Project team' section.
Be aware that collaborators are not notified via email once they have been added to a project. A named Collaborator can sign in and perform the same tasks within an application as the Project Deputy. Unlike the Project Deputy role, the addition of Collaborators on a project is not required. You can add Collaborators to help assist the CI and Project Deputy in completing key tasks.
Key tasks a Collaborator may perform in IRAS are:
- inviting a CI to access the project in IRAS
- adding a Sponsor or Sponsor Delegate Organisation to the project in IRAS
- adding and amending study Collaborators
- completing IRAS question sets (only if determined by the sponsor/CI to have relevant training and experience)
- uploading study documents
- forwarding the application to the Sponsor or Sponsor Delegate organisation for review and sign off
- REC booking
- receiving, reviewing and answering Requests for Further Information (RFI) (only if determined by the sponsor/ to have relevant training and experience)
- creating a new amendment
- creating a new report
- updating the CI or Project Deputy role
- a separate role as a Sponsor Group Organisation contact if appropriate
- submitting final reports
We do not recommend users create 'generic' email accounts for multiple users to access the system. Instead add as many Collaborators as required via their individual accounts. You can add and remove Collaborators at any time, unless a Collaborator has any open or outstanding tasks. For instructions on how to do this visit the section of this guide on Reassigning roles.
Collaborators can only access the study that they are allocated to as a collaborator. They cannot see other studies in the CI or sponsor group's portfolio.
The sponsor group is made up of the organisations that contribute to the management of the project. Adding an organisation to this group allows them to have oversight of the project in IRAS. You may have a single organisation listed in the sponsor group for your project, or you may have as many organisations as required added to the sponsor group. Regardless of how many organisations are involved in the project, you should only add additional sponsor organisations to your project within the system if they will need to access the application in IRAS.
An organisation can only be added to a project if it is already registered in the system. If the organisation you want to add does not appear as an option in the list, use this form to request a new organisation be added.
The sponsor organisation types that can be allocated in IRAS are:
- Sponsor- (this role also covers the Sponsor's Legal Representative for a non-UK based Sponsor within the European Economic Area/EEA)
- Global Sponsor- (for non-UK sponsors outside the EEA or approved country list) Please note: this type of sponsor can be added as free text. The Global Sponsor has no oversight of the project within IRAS and does not need an IRAS account. They cannot be assigned to the 'Sponsor or Sponsor delegate Organisation' role in IRAS.
- Co-sponsor
- Clinical Research Organisation (CRO)
- Clinical Trials Unit (CTU)
One (and only one) of the organisations listed in the sponsor group must be assigned the role of 'Sponsor or Sponsor Delegate Organisation'. This role can be undertaken by any of the organisations in the sponsor group, except the Global Sponsor. The 'Sponsor or Sponsor Delegate Organisation' will accept the responsibility of authorising applications and amendments in IRAS. All other sponsor group organisations will have read-only access to the project in IRAS. Refer to our Functionality for Sponsors page to find out how to assign the 'Sponsor or Sponsor Delegate Organisation' role.
If the sponsor has delegated the role of authorising the application to a CRO, the CRO should be made the Sponsor or Sponsor Delegate Organisation. The activity of the Sponsor or Sponsor Delegate can be undertaken by the same person acting as Project Deputy if required. For example, a CRO may be responsible for both preparing the application and authorising prior to submission. They would undertake the role of both Project Deputy (allowing them to prepare the application), and the Sponsor or Sponsor Delegate role (allowing them to authorise the application).
As long as one organisation has been allocated the 'Sponsor or Sponsor Delegate' role, the actual sponsor does not need to work on the project within IRAS. You do not need to assign a sponsor group role to the sponsor itself. This does not change the sponsor's legal role or responsibilities for the study. It simply means that they have delegated the management of the study within IRAS to someone else. Key tasks the Sponsor or Sponsor Delegate may perform in IRAS are:
- review and sign off submission of application. Only the 'Sponsor or Sponsor Delegate Organisation' role will undertake this task
- make changes to the sponsor group