This manual guides System Administrators through the use of the User Accounts menu item under the System Administration area on your iRIS home page, as seen in the image below.

Note: If your institution has purchased the LDAP interface along with your iRIS software, many of the settings within this manual apply differently to your system. Please contact your Project Management or Customer Support Representatives for questions regarding LDAP configurations.

User Accounts

The User Accounts page lists all of the users in alphabetical order.  Search for a user by filling out all, or some, of the search criteria in the filter at the top of the screen. Additionally, from this screen you have the ability to Download and Upload user templates, Add a New User, Delete User(s) and configure specific user’s information, all of these items are described in the sections below.

Switch to User

Switch to User – Selecting this icon will allow you to switch to that users complete view of iRIS.  Switching to a user will direct you to that users home screen, the account at the top of the header will list the username of the person you are working under, but will designate that you are under someone else’s account, and give the option to return to your own account, as seen in the image below.

Note: This option can be turned on or off for both the System Administrator role and System Admin Level 1 role in System Configuration under System User Profile Settings. Please see the System Configurations Manual for additional information regarding this setting.

Username

Username – Lists the last name then the first name of the user record. Selecting their name gives you the ability to access and make changes to their personal information (i.e., account and contact information).  The System Administrator Level 1 will only have read-only access to this screen.

After selecting the user, you want, the above screen will appear where you will be required to fill out User ID, Last Name, Password and Password Verify.

1. User ID – This must be a unique name for the user.  If the ID is not unique, an error message will open when the account is saved.  Before saving the account, the ID must be changed to a unique name.
2. Password – Enter the password for the user.  There are Password Security Settings that can be set in system properties to enforce a strong password.  These include:

• Enforce Strong Password
• Minimum Password Length
• Alpha/Numeric Password
• Password Expiration Period

Please see the System Configuration manual for more information on Password Security Settings.

3. Password Verify – This must be the exact same password as entered in the Password field.  Note:  The password is case sensitive.  If this is not the same, the account cannot be saved.
4. Status – Click the drop-down list here to set the status of the user.

• Active – This specifies that the user is active and will receive any E-mail notifications that relate to the user.
• Inactive – This specifies that the user is inactive and will not receive E-mail notifications.  (They will also not be able to log in to the system.)

5. Login Enabled – If the checkbox is checked the user will be able to log onto iRIS. If the checkbox is not checked, they will not be able to log onto iRIS.

From this area, other account information can be added, such as the users contact information, job title, CITI ID, etc. depending on how your iRIS system is configured. This area is described in further detail later in this manual in the Add a New User section.

Additional Email Addresses

In the User Accounts page, you have the option of setting another email address as the receiving notifications email, if it is different than the one listed in the "Email Address" field in the user’s profile.

To add additional email addresses, click the Add button (screenshot above).

Selecting to add additional emails addresses will bring you to the following screen, where you can enter the email address in the Email Address field. Once done, click on the Submit button.

Use for system Notification- you may select one of the following listed emails to be used for notifications. This email selected will be designated for notifications. All notification will be sent to the email selected.

Note: If the Email Address is unchecked to be used for system notification, a selection can be made from the Additional Email Addresses. Only one radio box can be selected at a time.

To remove an existing additional email address from the list, select the checkbox next to the appropriate email.  To remove, click the Remove button.

Assign Access

Assign Access – Click the icon in the image above to assign a user’s access; including, system roles, department association, and review board access. This icon will bring you to the screen in the image below. Note: System Administrator Level 1 does not have access to this area.

Details regarding setting these access areas are specified below in the System Role and Access section.

After assigning access, click the Save User Access (see screenshot above). Click the back button to return to the User Accounts Screen.

User Training

User Training – Click the icon in the image above to assign a user’s Training. See the User Training manual for additional information on configuring user training.

Additional Account Information

User ID – Displays the User ID. The user will use this ID to log into the iRIS system.  This is set when first creating a new account, or by selecting a user’s name under the Username column in the above screen shot.  

Primary Department – Displays only the user’s primary department that the System Administrator sets in the Assign Access page.  If no primary Department has been selected, None Selected will display here.

Login Enabled – Displays “Yes” if the user’s login is enabled (they can log into the system).  Displays “No” if the user’s login is disabled (they cannot log into the system).  This feature is set in the user account information page.  

Note:  Setting the account status to “Inactive” will override the “Yes” option.        

Status – Displays the user’s account status (see the image above).  This is also set in the user account information page.  If it is set to “Active”, the user will be able to log into the system (dependent on login enabled setting) and receive E-mail notifications.  If it is set to “Inactive”, the user will not be able to log into the system or receive E-mail notifications. The user’s name is also removed from user search lists in the system like the Key Study Personnel selection list, when associating personnel to a study. Note: The best business practice is to update a user’s profile with a Status to “Inactive” rather than to delete that user form the system, so that past history from that users account is not lost.

Date Created –Displays the date the user’s account was created (see the screenshot above).  

Notes – (see the image above) Click on this icon to view or add any notes to the user’s account.  If the background of this section is green, there is already a note posted for the user.  If it is red, no note has been posted.  These notes will only be accessible in this area.  Only the author of the note will be able to edit or delete.

Download User Profile Template and Upload User Profiles 

Download and Upload User Profile Template – You also have the ability to upload User Profiles into the User Accounts list rather than entering them into the system one-by-one.

First, download the template (downloads an excel spreadsheet with the template) in order to format the information appropriately for the system upload.  Once downloaded, fill the template/Excel spreadsheet out with the necessary information and save. Selecting the Upload User Profile button will allow you to upload the completed template back into the system and import the data that was input.

Tip: Each row in the template signifies one user and any number of user profiles can be added but be sure to remove the example record that is auto populated in the template, or that information will try to pull into the system as well.

A separate window will open in order to give a status update of each user profile uploaded.  Any unsuccessful row will list a reason as to why the attempted row was unsuccessfully uploaded as a user profile.  Each successful row will also be noted as to whether the uploaded row was a new user profile or whether the row updated an existing profile (this updating and adding is based on properties in System Configurations).  If any lines in the template failed to upload into an appropriate user profile, you can fix the template and upload the template again.  Note: If an institution is implementing LDAP accounts or joint iRIS and LDAP accounts, then the system configurations related to updating and adding user profiles in this way should be turned off to avoid unwanted updates to password and contact information.

Delete User(s)

Delete User – To delete an account, click the icon in the Delete column. Note: Never delete the Administrator account in iRIS.

Add a New User

To add a new account, click the Add New User button (screenshot above).

The only required fields are User ID, Last Name, Password, and Password Verify, assign the user ID and password.  The password will display in asterisks, but you will still be able to change a user’s password after the account has been created, if necessary. Job Title can be a required field as long as the property is set as such. Other user information such as Suffix, First Name, Middle Initial, Job Title, Degree, Employee ID, Primary/Cell/Pager/Fax Number (has to be 10 numeric characters), Location, Specialty, and National Provider Identifier may be entered.

The E-mail address that is entered here is the E-mail address that will receive all notifications sent to this user.  It is important to make sure that the E-mail address entered here is correct.  The user will not receive important notifications if it is incorrect.

If the Force user to change password at next login is checked, the user will be required to change their password at next login.  The Login Enabled checkbox is checked by default, which means this user will be able to log in to the system.  If it is not checked, then this user will not be able to log in.  If the Add to Physician List checkbox is checked, then this user will be added to the system’s physician list.

The Status drop-down sets the status of the user as inactive or active.  If the status is active, the user will receive E-mail notifications and correspondence. If the status is Inactive the user will not receive E-mail notifications and correspondence.  The Select Affiliations area contains predefined affiliations a user might have. To add affiliations, go to User Accounts -> Choose User from list -> Check Affiliation or Non-Affiliated under the heading Choose Relationship to the Institution on the next screen. The Social Security Number, Military Branch, Rank, and Service Corp fields can be turned off in System Configurations under System User Profile Settings.

After adding the necessary information, click the Save User button (see the screenshot above). This will take you to the following screen (see the screenshot below), where you will have the option of Assign System Role and Access, Set Up Training Records, Add Another User, Return to User Accounts.

System Role and Access

Upon creation, the user is only able to access one area of the system, the My Assistant module (see the screenshot below). The items available to users within My Assistant may vary depending on how your system is configured, and what modules of iRIS were purchased.

The System Administrator has the ability to assign users additional system access and rights to certain departments, boards and committees in the User Accounts tool of System Administration. In order to establish the right roles for each user, the administrator must have a good knowledge of iRIS user role definitions and functionalities. Also, he or she must know exactly what the user will need to do in the software.  Before assigning a role, make sure that what is required of each user is known. To access this screen, locate the desired user within User Accounts then click on the Assign Access link (as described earlier in this manual).

Clicking this icon will bring you to the following page:

System Level Roles

System Level Roles are available to grant high-level access to users. These are typically administrative roles, allowing a user to have administration rights to a certain module or area of iRIS. Each role is described below. Your system may or may not have the same roles available, depending on which modules are turned on.

Full System Administrator – This role grants full access to the System Administration module and will also allow the user rights to Find a Study within Study Assistant (a Department must also be associated to the user).

System Administrator Level 1 – This role gives the user limited System Administration privileges. The role may view user account information. They have access to enter user training, medical licenses and CVs for each user in the system. Their ability to add or delete users will be dependent on the System Configurations set. They may also run specific reports. They can also have the menu group called Config. Departments depending on whether the property is turned on in System Configuration under System Default Settings.  

Auditor – This role will only display if you have purchased the Audit Assistant.  This role will create a new menu group in the user’s iRIS account called the Audit Assistant.  This assistant is very basic and used mainly to audit all aspects of a study.  Through this assistant users have access to any study, meeting, or document that has been included in an Event to which they have been given access.  Only System Administrators create Audit Events in the Auditor Assignment list. 

Department/Site Administrator – This role will have full access to the Study Assistant module (a Department must also be associated to the user). This role allows the user to oversee all items pertaining to the department, or departments to which the users given this system level role has access. This role may run reports specific to the departments associated to the user and set-up specific department tools. 

Global Study Access – This role gives the user access to all studies regardless of whether they have a role on the studies or not (a Department must also be associated to the user). The Global Study Access role will have a column in the Study Role Access page in List Configuration and Maintenance so you are able to control what items the global study user will have access to within the studies.

Global Subject Access – This role gives the user access to all subjects in the system regardless of the user’s department association and the patient’s department association.  For example, when that user does an open search for a subject, then all subjects on every study will display.  However, if that user does not have global subject access, then only the subjects that have associations with their departments will be pulled in from an open search. 

Report Administrator – A user can be given this role so that they will not have full System Administrative rights, but they will still have access to System Report Administration under their My Assistant.

Grant Submission Authority – This role is available if using the eProposal module to submit grant applications electronically to Grants.gov. A user with this role will have the ability to submit a funding opportunity to Grants.gov.

Effort Report Administrator – This role is available if using the Effort Reporting module. A user with this role will have the ability to monitor user’s effort reporting.

Review Board Access

This area allows the association of review boards. Only review boards that are enabled within the system will populate in this area, so you may or may not have the same boards as shown in the example below.

Allow User Access – The first step in granting a user a role on a specific review board is to select the checkbox next to the board. This will enable that review board for their user account.

Default Review Board – Selecting the default review board is an important tool for users who have access to multiple review boards. The default review board will be the review board that displays on their home screen when users first login into iRIS. Users will have the ability to switch review boards by selecting the Review Board Icon on their home screen, as seen in the image below.

User Role – Click this button to assign the specific role on the board to the user. The page that opens will display a grouping of roles available for each committee defined within that board.

If a user is given access to multiple committees, (access given by selecting the Committee Access checkbox) under a specific review board, a drop-down menu will become available to change between committees on their home screen, as seen in the screenshot below.

A user can be given Review Board Administration by selecting the Grant IRB Administrative Rights. this gives the user access to the Review Board Administration link within the IRB Assistant on the user’s home screen.

Please see the Review Board Administration manuals for additional information on this area.

You can also assign a lower-level administration role to a user by selecting Grant IRB Jr Administrative Rights. This will provide the same Review Board Administration link but with limited functionality within (Outcome Letter Templates, Risk Assignment Configuration Lists, Drug and Device Configuration Lists, etc.).

Voting Member – A user who has been assigned a role on a specific committee and who is also flagged as a Voting Member will populate in the Meeting Motions and Submission Vote screens, allowing you to specify how they voted on a particular motion. You can also restrict reviewers to voting members only by setting the review board property “rb.restrict_reviewer_to_voting_member” within the Reviewers group.

Roles – The list of roles on this screen are defined within Review Board Administration -> Setup Review Board Roles. Each role on the board will have certain access based on the settings within Review Board Administration -> Setup Role Access. A user can only have one role on the committee but can have a role on multiple committees.

Note: The Committee Access checkbox must be checked before assigning any role and/or voting privileges.

1. Board Member – This role is used to designate members that review and vote on submissions (provided the Voting Member flag is set).
2. Coordinator – This role is designated as the role that receives the submission and processes the submission through the review board. This role is designated as coordinating the completion of each submission that is received by the review board. A person assigned to this role has more access to the Review Board Assistant module than a regular user with Review Board access.

Coordinators also have the ability to set review processes (assign to review committee agenda, expedite, pre-review changes, etc.) They can assign reviewers to a submission, create submission correspondence, and determine the outcome of a submission (Outcome tab). This user will also have access to the Review Summary and can view all of the reviewers’ answers on the Reviewer’s comment form and incorporate those answers into the Meeting Discussion that could then be merged into outcome letters or minutes. If a user has this role they also have access to the Vote/Acknowledged By tab, allowing them to set the member vote as long as a member-voting list is created.

3. Chairperson – This role designates the person that leads the meeting and is the final signatory to any outcome letters.
4. Data Entry Member – This role is used for data entry.
5. Non-Voting Member - This role is used to designate members that are members of the board but do not have the ability to vote on motions.
6. Vice-Chairperson – This role will be designated as an alternate to the Chairperson when the Chairperson is not present. They will have the same access as the Chairperson.
7. Expediting Board Member – This role is used to designate members that are voting members for meetings and also members that can be used for expedited submissions.
8. Administrative Assistant – This role is used for data entry.
9. Ex-Officio Member – This role is used for members that are present at the meetings for observation.
10. Consultant/Ad Hoc Reviewer – This role is used for reviewers based on an area of specialty. The reviewer is typically an expert of the submission.
11. Alternate Member – Select this role to give the user the ability to be selected as an alternate for another board member. By selecting this role, the user can be an Alternate multiple board member.  (Only users that have the board member role for that committee will appear on the list).

Note: This role may also have access to different features, depending on the configuration of the iRIS software. To adequately address the scope of this role, please contact your iMedRIS Support Representative.

Only one Review Board role can be selected per user per committee. A user cannot have the Coordinator role and the Board Member role on the same committee. However, a user can have a role as a Coordinator for one committee, and a role of Board Member for another committee.

To remove a user from a committee, de-select the Committee Access checkbox then click Save Committee Role. If the role is not saved, the information will not change.

Note: The Configuration for roles can be found in Review Board Administration. Please see this manual for additional settings on creating Review Board roles, as well as configuration each roles access and settings.

Departments

Users have the ability to assign users with an association to a specific department. Departments are defined as a means of identifying the association of a user’s department to the departments attached to Studies. Departments are also the key element in providing users with access to Study Assistant on their home screen.

Selecting to add a department will bring you to the following screen, where the available departments in the system can be associated to the users account.

Note: Departments are configured in System Administration -> List Configuration and Maintenance. Please see this manual for additional information on configuring departments in iRIS.

The Add Department Search window will display (see the screenshot above). You can search for a department by Department Name, Dept. Code, Institution Name or School Code.  Once you locate the department, click the checkbox next to the department name, then click the Save button.

Default Extra Department to User Account

When the system updates existing user accounts through the iRIS Banner Interface, the last department added to the User Department Access will be automatically defaulted as the Default Department. Users to receive access to the department automatically without manually changing the defaulted department. This option will become available when the following property system.user_upload_allow_update is set to “Yes”

If a department is assigned to a user, the user will also have the Study Assistant module available.

Account Requests

This portion of the manual specifically guides System Administrators through the steps involved in user account requests and account approvals. 

Request on the Homepage

When reaching the main iRIS login page, users without an iRIS account, have the ability to Request a New Account as seen in the image below.

Note: Request an account button on the login screen is only available when the property: system.use_account_request is turned to “Yes.” Please see the Sys Admin - System Configuration Manual for additional information on this property.

After clicking on the Request New Account link (see the image above), users are directed to a screen where their account information can be entered. The Last Name, First Name, Primary Number, E-mail, and their account Department association is required, but additional information can also be entered, (see the screenshot below), and will be saved to their account after it has been approved by a System Administrator.

After selecting Submit Request button (see the screenshot above), users will be displayed with a confirmation pop-up.

Note: Once an account has been approved, (steps to approve an account are detailed below) the system has the ability to send an E-mailed notification to the new users listed email address. This notification is called Account Created Notification and is configured to inform users that their account has been approved, as well as any other applicable information regarding steps to logging into iRIS, and so forth. Please see the System Administration List Configuration and Maintenance Manual for additional information on the configuration of this notification.

Request in My Assistant

In addition to users requesting accounts from the Login screen. You have the ability to allow users to request accounts with the My Assistant tab of the Home Screen for other users, as seen in the image below.

Note: The Request New Account button in My Assistant is only available when the property system.use_account_request in my assistant is set to “Yes.” Please see the Sys Admin – System Configuration Manual for additional information on this property.

After selecting the Request New Account button, users are directed to a screen where the account information can be entered. The Last Name, First Name, Primary Number, E-mail, and their account Department association is required, but additional information can also be entered (see the screenshot below) and will be saved to their account after it has been approved by a System Administrator.

Approving Account Requests

Selecting the Account Requests menu item (see the screenshot above), a Site Access Request page displays all of the requests for new accounts.  These are listed in the order they are received; the oldest requests display at the top.  Once an account has been created for a request, the record will disappear from this table (see the screenshot below).

Existing User

Click the Existing User icon to direct you to a screen that will display a list of Possible Matches, to existing users. This can be used in cases where a user is requesting an account, but already has an account setup within iRIS. Once the applicable existing user is selected the system will display the Existing User Information alongside the New User Information as seen in the image below. Additionally, selecting the Edit User Account Information icon will bring you to the users User Account Information, where the existing record can be edited or updated. Note: this is helpful, as you have the ability to update items within the user account information, such as the password. When contacting the user who is attempting to create an account, you are able to quickly make them aware of their existing account, and their current updated password.

Add/Edit Account

The Add/Edit Account icon will bring you to the area where the account can be added to the system, as well as additional applicable information. From here there are a couple required fields: the User ID & Passwords as seen in the image below. Other items that can be configured here include the Status of the account, whether the account is enabled for login and additional user information.

Define Reminder

Select the Define Reminder button to setup an E-mail notification each time a request is made.  The recipients of this notification can also be set in this area, as seen in the image below.

Title – Enter the title you want associated to the notification

Send E-mail Notification – this notification can be disabled without deleting it. Selecting No to this field will turn off this E-mail from going out to the designated users email address. Setting this setting back to Yes will cause the notification to continue to fire.

Notify Every Request – This setting will allow the system to trigger the notification on every request made, or not.

Define E-mail Content – Selecting this button will populate a Rich Text Editor, where the content of the E-mails being sent can be added, edited, and formatted.

Add Notification Recipient – This button will allow you to add the specific recipient who should receive the notification. (Be sure to add user(s) with System Administrative rights to their accounts, so that they have the access needed to approve incoming account requests).

Delete Notification Recipient(s) – This button allows you to remove recipient(s) form the list. Be sure to select the check box next to recipients who have been added before selecting to delete.

Be sure to Save Changes to notification definition before navigating away from the screen to save.

Delete request

Clicking the icon in the Remove column will allow you to remove a request from the list, if you do not wish to approve the request or match the request with an existing user account.

Locked Account

If a user has forgotten their password and attempts to login past a specific number of times, (the number of available login attempts can be set in System Configurations) the system has the ability to lock the user out of their account.

Note: Setting the number of allowed login attempts is a configuration in the System Configurations area of iRIS. Please see the System Configurations Manual for additional information on adjusting the allowed login attempts.

When attempting to login with the wrong password, the system will first prompt the user that they only have a certain number of tried left before the account is locked, as seen in the image below.

If the user continues to unsuccessfully attempt to login, the system will then notify the user that either their account is locked (and must be unlocked by the system administrator) or that there is a set number of minutes before they are able to attempt to login again (this amount of time is also set in the system configurations area).

Note: If an account has been locked, there is a Locked Account notification which can be setup and sent to designated System Administration accounts. Please see the System Administration List Configuration and Maintenance manual for additional information.

In addition to the notification, the User Accounts area will also prompt you if an account has been locked, as seen in the image below. Selecting to unlock the users account can be done by selecting the below prompt.

Account Password Requests

If a user has forgotten their password, they have the ability to request their password from the login screen, using the I forgot my Password button as seen in the image below. If the wrong password is entered the system will prompt them to use this button, stating “You may receive your password by the link “I forgot my Password” below.

Note: This setting only works with the System Configuration property set to Yes System.use_forgot_password_request. Please see the System Configuration Manual for additional information on this property.

Users will then be able to input their User ID to have their password emailed to the email address listed in their account, as long as a current email address has been setup in their profile.

Note: There is a Password Request notification which can be setup and sent to designated System Administration accounts. Please see the System Administration List Configuration and Maintenance manual for additional information