The data on the Staff & Access page can be added, removed or modified at different stages of the protocol application and submission process. Because of the transactional nature of the page, security rules are enforced according to what state the protocol is in and what type of access a user has been granted. If a staff member is removed from a study, they will no longer have access to the protocol. Below are the security rules:
For new protocol submissions that are created in Insight via the eIRB process:
Upon selecting a role of ‘Principal Investigator’ or ‘Site Responsible Investigator’, the Contact Person box is checked and Manage Permission access is assigned. These default settings cannot be changed.
Anyone with Edit or Manage access to the protocol can add, remove or edit study staff before the HRO ‘Accepts’ the submission. Once the HRO accepts, only the Permission and Contact Person columns can be edited. To make other changes to the study staff, the user must wait until the submission is reviewed and the overall status changes to ‘Req Mod’ (requires modification). If the status does not change to ‘Req Mod’ but to ‘Approved’, then an Amendment is required to add or remove study staff.
Anyone with Manage access has the ability to modify permissions (user access levels) before the HRO ‘Accepts’.
Anyone with Edit or Manage access to the protocol can add non-study staff (default permission is ‘view’). Non-study staff names and access can be added, edited or removed at any time.
All users with View access to the protocol can access the Staff & Access page in order to view the study staff and non-study staff associated with the protocol.
If a user does not have a username, the user will not have access to the system and therefore the permission level will be blank.
For protocols that were created prior to the electronic submission process (a paper application was submitted and the protocol was manually entered into Research Express):
Principal Investigator, Site Responsible Investigator and any study staff designated as a contact person are assigned Manage access.
All other study staff members not designated as a contact person are assigned Edit access.
Study staff not assigned a role in Research Express (ReX) are assigned View access.
Any person designated as a contact person only (and not study staff) are designated as non-study staff and assigned View access.