This manual will guide you through the third tab in List Configuration and Maintenance within System Administration.

List Configuration and Maintenance houses many of the system wide list configurations, such as master lists, system setup tools, user setups, notifications, as well as maintenance tools, such as clean-up and system audits.

Upon entering the List Configuration and Maintenance area, you will have access to the configuration options, displayed as a tabbed list with 5 main categories, System Setup, Site List Setup, System Notifications, Clean-up and Audits. Each category is viewed by selecting the tab at the top of the screen. The following sections of this manual review functionality in the first tab System Setup.

System Setup

This tab allows a System Administrator the ability to set configurations which apply for the entire system. In the following sections, this manual will define the setup for each of these areas and provide the steps for their configuration.

Essential Setup

Definitions

This area of the system will allow you to define Institutions, Departments and Review Boards. These items are typically configured during the initial setup of iRIS.

Define the Institution(s)

Institutions can be setup in the system and are tied to Departments as needed; iRIS allows Departments to be associated to both Research/Study Users, as well as Studies. Institutions and Departments are considered a key source of identifying the segregation, of the Study Assistant attributes on a higher-level.

After selecting this link the master list of existing Institutions will display. You will have the ability to Edit existing Institutions, as well as Add a New Record and Delete, as seen in the image below.

Add a New Record will direct you to the following screen.

Institution Name – In this field you are required to designate the Name, you would like displayed for the Institution.

Institution Abbreviation – In this field you are required to designate the abbreviation, you would like set for the Institution.

Institutional Code – Allows the input of an institution code for the institution.

FWA Number – Allows the input of an institution FWA number (which is a a number issued by the Federal Wide Assurance for compliance) for an institution and is helpful for internal designation.

Street 1, Street 2, City, County/Parish, State, Province, Country, Zip /Postal Code – All allow for the address and contact information to be associated to the specific institution.

The only required fields are Institution Name, and Institution Abbreviation Setup Institution.  All other information such as Institution Code, FWA Number, Street 1 & 2, City, County/Parish, State, Province, Country, Zip/Postal Code maybe entered. Once a record has been saved into the system, it will be added to the master list.

Note: Once the record has been saved, Departments can be associated to the Institution within the Department setup, which is covered in the section below.

Define the Department(s)

Departments within iRIS provide a means of identifying the specific department, for a Research User as well as Studies. The designated names of these departments are unique to each institution. As a whole, Departments are defined as a means of identifying the association of users’ department to the departments attached to Studies. Departments are a key element and can be helpful in areas such as running reports, identifying a group of studies associated to a specific department or a group of users associated to a specific department.

After selecting this link, the master list of existing Departments will display. You will have the ability to Edit existing Departments, as well as Add a New Department and Delete, as seen in the image below.

Additionally, this page contains several Search By filters. These filters allow you to search for specific existing departments from the list.

Add a New Department will direct you to the following screen.

Institution Name – As was noted in the previous section, departments are associated to a specific Institution. Here the system displays a dropdown of all the current Institutions.

Department Name – In this field you are required to designate the Name you would like displayed for the department.

Depending on your system settings, the following fields may or may not be available.

Department Code – Allows the input of a specific code for the department and is helpful for internal designation. Additionally, this field is available within the Search By filters, when viewing the master list of Departments.

Department Parent Code – If the department is set up as a sub-department to a parent department, the system will display the internal code here, which the system will automatically designate for a parent department. Note: Configurations’ for the Parent / Child Department setup is detailed at the end of this section.

School Code – Allows the input of a school code for the department and is helpful for internal designation. Additionally, this field is available, within the Search By filters, when viewing the master list of Departments.

Street 1, Street 2, City, County/Parish, State, Province, Country, Zip /Postal Code – All allow for the address and contact information to be associated to the specific department.

Add Contact – If needed, the system will allow you to add specific contacts to be associated to the department. These contacts come from a list of users within iRIS. These contacts are also categorized. The main Department Contact, and Department Administrator Contact, additional contact categories can be turned on through properties which are defined in the Department / Site Setup portion of the System Configurations manual.

Edit Note – A specific note can be added and edited here. This feature is for internal use and purposes.

Upload– This is used for the Departments specific documents, such as Department Signature Authority Documents, that can be uploaded and associated to the department.

Adding Sub Departments – Once the needed fields have been entered and a department has been saved, the system displays an additional field, which designates the ability to Add a Sub Dept.

Selecting Add a Sub Department sets the previously saved department as a Parent department and allows you to enter the sub department’s specific information, with the parent department’s associated internal code displayed, as seen in screen shot below.

Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – As was previously noted, departments can be associated to Research / Study Users, as well as Studies themselves.

Associating a department to your account can be done in the Assign Access area, of the User Account tool in System Administration. This area contains a section that will allow you to Add or manage the departments associated to a specific account. See the Sys Admin - User Accounts Manual for additional information.

Associating a department to a Study is done during a studies creation of the study shell. Section 2.0 of all applications requires that department(s) be designated before the user can continue filling out an application. See the Study Assistant – Add a Study Manual for additional information.

Define the Review Board(s)

Review Boards can be added to the system, based on the amount of review boards that were purchased in user contract. Separate review boards allow the designation of access for specific members, separate Meeting Agendas, separate Outcome Letters and much more. Review Boards are only available to a user, if they have been given access to them within the User Accounts area of System Administration.

After selecting this link the master list of existing Review Boards will display. You will have the ability to Edit existing Review Boards, as well as Add a New Record and Delete, as seen in the image below.

Add a New Record will direct you to the following screen.

Review Board Name – This required field allows you to designate the Name, you would like displayed for the Review Board.

Review Board Type – This required field displays a dropdown, of the available Review Board types within your system. This list can vary, depending on the modules that were purchased and have been turned on in your system. Contact your Project Manager or Customer Support Representative for additional questions regarding the modules within this list.

Assurance Number – This allows the review board’s specific assurance number to be entered.

Review Board Assistant Name – This field allows the display name, on a user’s end, for the review board to be changed.

For example, institutions who have purchased multiple IRB’s may want their review board labeled such as “IRB 1 – Assistant” “IRB 2 – Assistant” or as needed.

Assurance Expiration –This allows the assurance expiration Date to be designated.

Comments – This allows the input of specific comments for the review board, and is helpful for internal designation.

Primary Address – These fields allow the designation of the primary address and contact information for the review board.

Color – This field allows the color designation for the specific review board.

Once a review board record has been saved into the system it will be added to the master list.

Status Roles

This area of the system allows you to configure the Study and System level roles which function throughout the system.

Define System Level Role(s)

The system is setup with a set of higher-level roles that can be defined to provide users with specific access. Many of the Roles are hard coded into the system such as Full System Administrator, Global Study Access and Department/Site Administrator. Additional roles can be added to the system from this screen, configured as needed and become available in the User Accounts area to be assigned to specific users.

See the user specific manual for users with the roles of System Administrator, as well as System Administrator Level 1 for additional information regarding these hard-coded system level roles.

After selecting this link, the master list of existing System Level Roles will display. You will have the ability to Add a System Role and Delete, as seen in the image below.

Add a System Role will direct you to the following screen, where each field is required; although, many of these fields will default to the correct setting, only in certain cases will any of these, need to be adjusted. See the definition for each setting, in the image below.

Role Name - Display name for the new System Level Role.

Use for Routing in Workflow - If set to “Yes”, this setting will allow the user role to be available when configuring form workflows within the System Workflow Designer Tool. See the Sys Admin– Workflow Designer Manual for additional information on this configuration.

Allow Research Role Access – If set to “Yes”, user can use the System Level Role to have access to Study Assistant and eProposal Assistant (if using the eProposal module) and provided the user also has a department assignment.

Use Global Study Access – If set to “Yes” to this, in System Level Role users will have global access to all studies within the system, provided that user also has a department assignment.

Use Global Project Access - If set to “Yes” to this, in System Level Role, the user will have global access to all projects within the system, provided that the user also has a department assignment.

Use Global Subject Access - If set to “Yes” to this, in System Level Role the user will have global access to all subjects within the system, provided that the user also has a department assignment. Use of this role requires that you have the Subject Management module enabled in iRIS.

Use Department Filter to restrict access – The departments in iRIS are setup to be associated to both Studies as well as Research Users. Setting this to “Yes” for a System Role will allow that user role to have restricted access, based on the department that has been assigned to that user with the specific role.

Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – System Level Role(s) can be associated to a user account through the User Accounts tool in System Administration. Selecting Assign Access for a user’s account will display the available roles. Assigning your role will provide your account with the configurations applied to the role within the above details.

Once a System Level Role is added to the system, you will need to ensure that proper access to studies, projects and subjects is designated within Study Assistant Role Access and Project Assistant Role Access (more information about these areas is described below).

Define Study and Project Role(s)

The system is setup with a set of Study and Project roles that can be defined to provide study users with specific access to their studies and/or projects. Some of the roles are hard coded into the system such as Principal Investigator and Study Contact. Additional roles can be added from this screen, configured as needed and made available to assign to study and project personnel.

After selecting this link the master list of existing roles will display. You will have the ability to Edit existing Roles, as well as Add a New Role and Delete, as seen in the image below.

The page also contains several Search By filters, that allow you to search for roles by Group, or if they are used on Studies or Projects within the system.

Add a New Role will direct you to the following screen.

Order Number – Allows the designation of the display order for the roles, when they are added to a Study.

Role Name – Designates the display name for the role being added.

Role Group Name – This drop-down list contains a list of available personnel role groups, you can associate this role to. You will associate a group to the role, depending on what kind of role you are adding. The available types are Investigator, Project Administrator Staff, Research Staff, and SMO. Each group corresponds to a different section in the Key Personnel, for Study and Project records.

Allow Animal Access – If your system is configured with the IACUC module, setting this field to “YES” will enable the role access to species added to the study.

Allow Subject Access – If your system is configured with the Subject Management module, setting this field to “YES”, will enable the role access to the Subject Management tab within the study.

Subject Consent Required – If your system is configured with the Subject Management module, setting this field to “YES”, will enable the role access to the consent subjects on a study.

Conflict of Interest Check Required – If your system is configured with the Conflict of Interest module, setting this field to “YES”, will flag you, if you are on a study, to be included in study-related conflict of interest checks.

Use on Study – Setting this field to “YES”, will enable this role to be in use for study records in the system. You will be able to add a user with this role to their study. If you want to stop using a role for a study record, instead of deleting the record, set this field to “NO” and you will no longer have the ability to associate users to this role moving forward.

Use on Project – Setting this field to “YES”, will enable this role to be in use for project records in the system. You will be able to add a user with this role to their project. If you want to stop using a role for a project record, instead of deleting the record, set this field to “NO” and you will no longer have the ability to associate users to this role moving forward. This field is only available if your system is configured with the eProposal Assistant turned on.

Allow Delegated Authority

Once a record has been saved into the system, it will be added to the master list.

Define Study Assistant Role Access

This feature will give a user the ability, by role on the study; read only access or full write privileges within certain screens.

After selecting the link to Define Study Assistant Role Access the Role Matrix is displayed, as seen below.

This page will list out available screens, on the left side of the matrix. The top of the page displays a list of current study roles. Within each role are checkboxes for Read and Write. Each of these cells represents the access a user can have, on the left side of the screen.

If the Read and Write checkboxes are both selected, that means that the user has full access to that page in the system – to view the page and update records on the page.

If the Read is selected, but Write is not selected, that means that the user has “Read Only” to that page in the system – to view the page but not modify records on the page.

You cannot give a user Write access to a page without Read access.

The first set of Read and Write columns are to turn on/off a screen in general. If you remove Read and Write access at the top level, none of the roles on the study will have access to that screen. This is recommended for use if you do not want a user to see a particular screen within study records.

There are vertical and horizontal scroll bars at the bottom and right of the screen so you can navigate to the other roles and screens available on the page.

The Role Matrix is broken up into the following study areas:

Submissions – This section contains screens within the Submission tab of a study record, with the exception of custom submission forms.

Study Management – This section contains screens within the Study Management tab of a study record.

Subject Management – This section contains screens within the Subject Management tab of a study record and will only apply to instances of iRIS with the Subject Management module enabled.

Forms Designer – This section will display any custom submission forms that have been published and made available to study management.

If you had setup a role in Define Study and Project Role(s), you would need to setup that roles access in the Role Matrix. Any new role added to the system will populate in a column in the Role Matrix (at the end of the list of roles). iRIS will default all Read and Write cells to be unchecked for the new role. You will need to review the role within the matrix and setup the appropriate Read and Write access for that role.

After making any changes to this screen, be sure to click the Save Changes button to save your work.

Status Setup

This area of the system will allow you to configure System Study Status’s essential to the operations within Study Assistant.

Setup Study Status

Create and maintain the statuses for studies. Determine what user access is allowed during particular statuses and assign different colors to each status. Study statuses are used for every stage in the life of a study, from the creation of the study record, and until the study is inactive.

This list is shared between System Administration and any other review board set up in the system. The study’s overseeing review board will maintain the study status of a particular study; however, the system will also default a study to a certain status depending on actions in the system.

The Delete column is used to delete a status. Some of the statuses do not have icons. This means they cannot be deleted from the system because they are hard coded and required by the system to run properly. To delete a study status, click the icon next to the study status.

The Edit column contains icons that you can click to open information about the status and Edit. Some of these statuses cannot be edited for the same reason they cannot be deleted. You may still view the read/write information about them (more later).

The Sort Order column determines how the statuses are grouped within this page, and also what order they appear on the Review Board and when viewing studies in Find a Study or My Studies in Study Assistant. 

Default for Expired Studies column indicates if a certain status is the default in iRIS for an expired study. This means that when a Review Board Expiration Date comes and goes, the system will automatically set the study to this status. There should be only one status with this option turned on.

Continuing Review Reporting column indicates if continuing review reporting is included with this study status. If this reads Included, then continuing review reporting is included. If this reads Not Included, then continuing review reporting is not included in this status.

Auto Expire indicates whether the system checks studies in that status to see whether or not the Review Board Expiration Date has come and gone.

Available to Archive indicates whether or not you can archive studies in this status. *Used with IACUC modules.

Include Match in COI indicates whether the system checks a study in this status for sponsor information when a Covered Person submits a form. If the Covered Person has a role on the study and has indicated a conflict with a sponsor on the study and the study is in a status that includes the COI check, a Conflict Match will trigger. *Used with COI modules.

The Color column contains a sample of the assigned color for this status.

To create a new study status, click on the Add New Study Status button.

The Study Status Formulary page will open. The first two fields are required fields. Study Status is the actual name of the status. This will be associated with any study that is set to this status.

Sort Order – Enter a number here to determine where in the order with the other statuses this status will appear. You can only enter a whole, non-negative number in this text box.

Default for Expired Studies – Click the checkbox to indicate if a certain status is the default in iRIS for an expired study. This means that when a Review Board Expiration Date comes and goes, the system will automatically set the study to this status. There should be only one status with this option turned on.

Continuing Review Reporting – Select either “Not Included” or “Included” depending on whether or not you want to allow continuing review reporting with this study status. Only one of these can be selected at a time.

Auto Expired? – Select “Yes” to indicate whether the system checks studies in that status to see whether or not the Review Board Expiration Date has come and gone.

Include Match in COI – Select “Yes” to indicate whether the system checks a study in this status for sponsor information when a Covered Person submits a form. If the Covered Person has a role on the study and has indicated a conflict with a sponsor on the study and the study is in a status that includes the COI check, a Conflict Match will trigger. *Used with COI modules.

Status Available For – Select any of the boxes next to the board assistant you would like to apply to. This section includes a list of all the boars that are currently in the client’s iRIS system. Any of the boards presented can be selected to include the status being edited or added to the system. * When the status is initially created, none of the boards within the Status Available For list will be selected

Available to Archive – Select “Yes” to indicate whether or not you can archive studies in this status. *Used with IACUC modules.

Operations Allowed – This is the area that determines user access and changes to the study when it is set to this status. The first two items (highlighted yellow) determine whether KSP has access to the study while the study is in this status. If the first check box is checked any KSP associated to the study can open the study and make changes. If the second option is selected, the KSP would have access to the study, but they would not be able to make changes. Both of these can be selected at once, but this is not recommended. If neither checkbox is selected, KSP will not be able to access the study through My Studies or Find a Study in the Study Assistant.

The rest of the options are as follows:

Study in Creation Mode – This property allows the study to act like a Draft status.  

Allow Submissions – During this status, if this is checked then KSP can make a submission to the Review Board. If it is not checked, forms cannot be submitted.

Allow Key Study Personnel Change – If this is checked then the KSPs associated to the study can be added or removed from the study. In the screenshot above, the checkbox is not checked meaning the KSPs cannot be changed at this status.

Allow Subject Access – When this checkbox is checked, subject management is allowed. If it is not checked, you cannot modify the subjects associated with the study. *Used with Subject Management modules

Allow Subject Enrollment – When this checkbox is checked, you are able to enroll subjects to the study. If it is not checked, you cannot enroll subjects to the study. *Used with Subject Management modules

The color palette is located at the bottom of the screen. To change the color of the status, click on the desired color.

The present color shows in the large box next to the color palette. Make any necessary changes to the status, then click the Save the study status button.

The new study status will appear in the list of study statuses. It will appear in the order you choose in the Sort Order text box.

How these configurations affect iRIS

The Study Status will be changed from the iRIS default status when the IRB is giving final approval of a submission, as shown below.

Study Status will be available within My Studies and Find a Study

The study status also shows in any screen associated with a study, whether the study is being viewed from Study Management, IRB Assistant or any other module.

News, Announcements and Broadcasting

News, Announcements and Broadcasting contains the ability to broadcast updates and system wide announcements as needed.

System Announcements

System Announcements is a tool that will allow you to send out an announcement that will populate on all user’s homepage.

After selecting this link, the master list of existing Announcements will display. You will have the ability to Edit the existing as well as, Add a New Announcement and Delete, as seen in the image below. Remember to select the checkbox to the left of the record that needs to be deleted, before selecting the delete button.

Add a New Announcement will direct you to the following screen.

Name – The Name entered here will display as the title of the announcement.

Date – The Date entered here will display as the date the announcement is being posted for. Keep in mind this is not the date the announcement will go out, simply a reference date; the announcement will go out to users the date that it is sent.

Announcement – Selecting the Announcement link here, will allow you to copy and paste or type into a text editor, and will displayed as the contents of the announcement to the user.

Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – After entering and saving these fields, the system will display a system wide announcement. The next time a user logs into the system the following horn icon seen below, and a notification will display on their home screen:

Users can also find a history of previous announcements that they have received. These records are located in the My Assistant tab, by selecting the announcements option within this tab.

System Broadcast

The System Broadcast feature is similar to the system announcements; however, sending a broadcast will send an email to all active iRIS user accounts.

After selecting this link, the master list of existing Broadcast Notices will display. You will have the ability to Edit the existing as well as, add a New Notice and Delete, as seen in the image below. Note: You cannot delete notices that have already been emailed. If the notice has been emailed, no icon will display in this column.

Add a New Notice will direct you to the following screen.

Subject –The Subject (required field) entered here will display as the title of the broadcast within the email.

Content – Content will allow you to enter the applicable broadcast data/message into a text editor. After saving the data it will be displayed as the contents of the broadcast within the email.

Attachments – Attachment will allow you to upload an attachment if needed, which will be attached to the email.

Temp Save Notice – This button in the top right-hand side of the screen will allow you to Save the Notice without sending it (This is available for creating a notice to send on a later date).

Send – This button in the top right-hand side of the screen will send the Notice out to the users. Once this button is selected a popup screen will provide 3 sending options.

Send the broadcast with the default settings to Send to everyone:

Or, if this box is de-selected, 2 additional options will display, Send to all Principal Investigators and Send to Review Board Members:

Once a record has been saved into the system it will be added to the master list.

Business Associate

This portion of System Administration allows you to configure and maintain records related to Sponsors, Subrecipients, Vendors and other associative lists (Competitor, Purchaser, Research Affiliate, etc.).

Sponsor Type List

This is a list of available Sponsor Types that you can associate to a Sponsor record.

After selecting this link, the master list of existing Sponsor Types will display. You will have the ability to Edit the existing, as well as Add a New Category and Delete, as seen in the image below.

Add a New Category will direct you to the following screen.

Sponsor Type – Here you are required to designate the display name for the Sponsor Type record.

Sort Order Number – Set the order in the way that you want the Sponsor Types to display.

Include Sponsors of this group in Disclosure Search – This setting is used for the COI module. Any sponsor associated to a Sponsor Type with this flag set to YES will be included in the conflict of interest check. This means, when a Covered Person submits a conflict of interest form, with a conflict match listing a sponsor with this type, the system will flag a COI match and report it to the Conflict of Interest board.

Description – Here a description related to the type can be added. This field is for internal purposes and will not be displayed to end users.

Once a record has been saved into the system it will be added to the master list and will be made available to associate to a sponsor record.

Customer Vendor Type List

Customer Vendor Types can be created in the system. These types are available to be associated to Business Associates when they are being added to the system and associated to the Vendor group within the Associate Group settings.

After selecting this link, the master list of existing records will display. You will have the ability to Edit the existing, as well as Add a New Type and Delete, as seen in the image below.

Add a New Type will direct you to the following screen, where a name for the Type must be entered. Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – Below you will see how Business Associates are added to the system. Within this same area, a record can be assigned the group of Vendor. Once this group has been assigned the additional configurations below are populated on the screen. These configurations include the Sponsor Type, which is created during the configurations described above.

Business Associate Contact Category

Business Associate Contact Category allows you to create categories to associate to Business Associate Contacts.

After selecting this link, the master list of existing Categories will display. You will have the ability to Edit the existing, as well as Add a New Record and Delete, as seen in the image below.

Add a New Record will direct you to the following screen, where a name for the Category Type must be entered. Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – Below you will see how Business Associates are added to the system. Within this same area, a sponsor contact can be assigned. The configuration above allows the creation of a category list for those contacts.

Business Associate List

The Business Associate List contains a list of any institution you need to track as a Sponsor, Subrecipient, Vendor, etc. Records added to the Business Associate list can be used in a variety of ways in the system. They can be added as a study sponsor, or as a third party for a conflict of interest, or as a sponsor or subrecipient on a project.

After selecting this link the master list of existing Associates will display. You will have the ability to Edit the existing, as well as Merge Associate Records, Add a New Associate and Delete, as seen in the image below. Additionally, this page contains several Search filters allowing you to search for a specific record.

Selecting Add a New Associate will prompt you to enter the below fields. Saving this information will add the record to the list of Associates/Sponsors within iRIS.

Associate Abrv – Allows the designation of an abbreviation for the particular associate but is not required.

Associate Name – Designating the associates name is a required field.

Status – Displays the internal status of the record, once the record is saved this status changes to an Active status.

Associate Group – Allows the designation of the group the associate should be labeled as, depending on the answer given in this list, additional fields below will populate, and be available for entry. Note: The Associate Group list is a configurable list.

Street 1 & 2, City, County/Parish, State, Province, Country, Zip/Postal Code – Allows the input of the Associate/Sponsor’s address or location information.

Once a record has been saved into the system it will be added to the master list.

Selecting to Merge Associate Records allows you to merge duplicate records within the system.

After making this selection a list of the existing records will populate. Selecting two or more records will allow you to merge and select the record that you wish to keep.

Note: For records already existing on Studies, the record that was kept will apply to all studies which had the deleted record applied.

How these configurations affect iRIS – Once a Business Associate / Sponsor has been added to the master list, they become available to be associated to Study Applications through a data value.

Selecting Add a New Sponsor to the Study will display a popup window, which will allow the user to search for the applicable drug.

Workflow Algorithm and Forms Datatypes Setup

This group contains various configurations related to workflow routing, values in submission forms and a load balancer.

Define Additional Signoff Routing Roles

Additional Signoff Routing Roles allows you to configure roles for use in signoff of submission forms. These roles are in addition to the Project and Study Roles and are used for Department and Administrative signoff on forms before institutional review.

After selecting this link the master list of existing roles will display. You will have the ability to Edit the existing, as well as Add a New Role and Delete, as seen in the image below.

The page also contains several Search By filters that allow you to search for roles based on their use on Studies or Projects within the system

Add a New Role will direct you to the following screen.

Role Name – Here you are required to designate the display name for the Role Name record.

Use on Study – Setting this field to “Yes” will enable this role to be in use for study records in the system. Users will be able to add a user with this role so they can review and signoff on submission forms. If you want to stop using a role for a study record, instead of deleting the record, set this field to “No” and users will no longer have the ability to associate users to this role moving forward.

Use on Project – Setting this field to “Yes” will enable this role to be in use for project records in the system. Users will be able to add a user with this role so they can review and signoff on submission forms. If you want to stop using a role for a project record, instead of deleting the record, set this field to “No” and users will no longer have the ability to associate users to this role moving forward. This field is only available if your system is configured with the eProposal Assistant turned on.

Once a record has been saved into the system it will be added to the master list and will be made available to associate to a study or project record.

How these configurations affect iRIS – The roles and titles will be available in a dropdown menu in your study application when you Add a Designated Department Approval as shown in the screen shot below.

This role can later be selected to sign off on the Study Application or other submission forms. Designated Department Approvals will be assigned prior to the submission reaching its destination review board.

MEDDRA Code List

If your institution uses MedDRA codes for tracking adverse events, you can upload the codes here. Any codes you upload will be available to pull into the Study MedDRA Code data value in the forms designer (shown below).

Setup Network Status

Network Status List provide the ability to create your own configuration lists when setting up a department. Once a network status list has been created and saved, you will be able to select a status for the department being setup within the Define Department link.

Configure System Linked List

System Linked Lists provide the ability to create your own configuration lists that can be made available in submission forms. The main feature within the Linked List is the ability to create lists within lists, so users can choose items within a selection. An example of how this could work is creating a Locations list that allows a user to specify the location of their research. They would first choose from the highest level, the campus location. Depending on what campus they select, the second level of the list would provide them a list of available buildings. The list could further be defined by room numbers based on the building chosen from the second level.

How these configurations affect iRIS – Below is a sample Linked List in a submission form.

First, the top-level item is selected from the list.

Once the top-level item is selected, another drop-down list will populate below the top-level list. This is the second level list, and the contents of this list will depend on the selection made on the top level.

Once an item is selected from the second level, depending on how the list is configured, another level will populate below the second level. Again, this list will vary depending on what item was selected in the second level list.

The Linked List can have any number of levels and any number of options in each level. Each option has the ability to have its own group of options in a level preceding it. Once an item is selected from a level, and there is no level underneath it, then the linked list is considered complete and no more levels will populate.

After selecting this link from List Configuration and Maintenance, the master list of existing linked lists will display. You will have the ability to Edit the existing, as well as Add a New Record and Delete, as seen in the image below.

Add a New Record will direct you to the following screen, where you will be able to type in the Record Name. This is the name of your list and will display in the master list of linked lists, as well as appear in the linked list drop down when associating a list to a form.

After entering the Record Name, click the Save Record button. The page will update with Level 1 of the linked list. Level 1 is the top-level list. There are three fields available here, Data Name, Select, or create new. The first two fields are not needed, as this is a brand-new linked list. You will enter in the name of the first item in your linked list in the create new field then click the Create button.

As soon as you click on the Create button the screen will update. A new row for Level 2 will populate and the Data Visualization table will update with the Level item you added.

Also, Level 1 now allows you to type in the Data Name and change selections in the Select drop down list. The drop-down list is only applicable when you have more than one Level 1 items created. The Data Name field is used to label your levels within the form (see the below image).1

At this point, you can continue to create Level 1 list items, or you can detail out the options that will appear to the user if the Top-Level Item 1 option is selected.

To create the Level 2 items for the Top-Level Item 1 option, type in the name in Level 2. Click the Create button. Repeat these steps for any number of items you need to add for the second level.

Each time you add a new item to Level 2, the Data Visualization table will update with the items.

Also, when you create Level 2, a Level 3 row will populate, allowing you to add items that will appear for selection items you made in Level 2.

As you add Level 3 items, the Data Visualization table will update.

At any time, you can choose to add additional items to any of the levels your have created. If you want to add another item to Level 1, go back to the Level 1 row, and change the value in the Create New field with the name of the new level item. Click the Create button and the next item will be added to Level 1 (see the Data Visualization table below).

You can then add Level 2 items to the new Level 1 item. Do this by verifying the new item, ‘Top Level Item 2’, in this example, is selected from the drop-down list in the Level 1 row.

You can then type in the new item for Level 2. In this example, it is called ‘2nd Level Item 4’ as seen in the image below.

Follow this same process for any items on any level. Choose the correct row, verify the correct item is selected from the drop-down list, then type the name in the Create New field below and click the Create button.

You can modify the name of any list item by locating the item from the Select drop down list in the appropriate level row. After making the selection, the current name will display in the Create New field. Change the item by making the change in this field, then click on the Modify button.

Any modifications will display in the Data Visualization table.

Level items can be deleted in the same way. Make the appropriate selection from the Select dropdown then click the Delete button. If you delete a level item, any items associated in lower levels will also be deleted. If you delete a level item by mistake, it will need to be rebuilt.

When you are finished building the linked list, click the Save Record button.

Linked Lists can be associated to any number of submission forms using the Linked List data value in the Forms Designer.

After selecting this data type from the drop-down list, you will be able to select which linked list to apply to the form. At the bottom of the page is a drop-down list Please select a linked list record. This list will populate with any saved linked lists in your system.

Note: If you build a form in one instance of iRIS and import the form into another instance of iRIS, you will experience issues publishing the form if you do not locate any linked list data values within the form and reestablish the links. Linked Lists do not transfer with an imported form and will have broken links that need to be reestablished.

Assign Review Board To Load Balance Algorithm

If your instance of iRIS is configured to use load balancing for submission forms, this area is where you can configure which review boards in your system should be used with the load balancer.

After selecting this link, the master list of existing review boards will display. You will have the ability Add a Board Selection Record and Delete, as seen in the image below.

Add a Board Selection Record will direct you to the following screen.

The list will display any available review boards that have not already been added to the load balancer. You can select a new review board to add to the list by clicking on the checkbox next to the review board name and then clicking the Save Board Selection button.

You should only add review boards to the load balancer that are of the same type. It would not make sense to attempt to load balance IRB Submissions between an IRB and an IACUC or other non-IRB module.

Load Balance Scoring Rules

In addition to adding Review Boards in the previous section, part of configuration for using the load balancer is to create a scoring system that will tell the system workload information for each review board included in the load balancer. Each submission form that is assigned to a review board creates a certain amount of work that can be tallied by the system. This tally will be taken into consideration when the system determines which review board should receive a submission.

You can create the workload scoring rules in this area.

After selecting this link, the master list of existing linked lists will display. You will have the ability to Edit the existing, as well as Add and Delete, as seen in the image below.

This page will display the Condition Name, Form Name and Score.

Clicking the Add button will direct you to the following screen.

Condition Name – Here you are required to designate the display name for the Condition Name record.

Score – Type in a numerical value that will make up the score for this item.

Form – Select the form type from the drop-down list. The list of forms here contains a list of all your published submission forms created in the Forms Designer.

After defining these values, click the Save button.

After saving, a table will populate at the bottom of the page, allowing you to define additional details for this scoring. If you need to track a different amount of points for a submission type meeting certain criterion within the form, you can create a rule here for that case.

The table allows you to choose a data column from the form and specify what value it should be in order to be included in the scoring. You can add additional rules as needed by clicking on the Add Rule button and delete rules by selecting the checkbox next to the rule and clicking the icon in the Delete column.

When you are finished defining additional rules as needed, be sure to save the page before navigating away.

How these configurations affect iRIS – You will only use Assign Review Board to Load Balance Algorithm and Load Balance Scoring Rules if your institution has multiple review boards of the same time that share submissions across the same studies and receive these submissions based on the review board’s current workload. Whichever board tallies the least amount of points based on the scoring will receive the next submission in the submission queue.

In order for this feature to properly work, you will need to have more than one board of the same type configured in the system and you will also need to modify the workflow for all submission forms that need to be included in the load balancer.

Look & Feel

Look & Feel contains configurations that will change items such as labels, colors, and overall feel of the system for users system wide.

Setup System Labels

Setup System Labels allows you to change certain hard-coded labels in the system.

After selecting this link, this very extensive list is broken into several sections such as List of Labels for System, List of Labels for Study, List of Labels for Drug Study, List of Labels for Device Study, List of Labels for User Role and KSP, etc.

Edit – If a label needs to be adjusted, select the Edit icon next to the applicable label. From the following screen you will be able to make the needed adjustment(s). Be sure to save your work, labels can be adjusted as many times as needed:

Predefined Name – This field will display the name that the label was originally set as within iRIS. This field is read-only.

Alternate Name – Displays the current name for the label. This means this is what the system is using in place of the Predefined Name, if different.

Description – Displays the applicable description of how or where the label is displayed within iRIS.

Setup System Images

Setup System Images is a tool that allows you the ability to upload new images for both the Login page, as well as the home screen.

The iRIS system comes with a set of default images preloaded in your system.

Login Page:

Home Screen Top Left Hand Icon:

After selecting Setup System Images link 3 images are available to be adjusted.

Edit – Selecting Edit will bring you to a page where you can upload a new image, as well as restore the default image to the original iRIS system default. Uploading a new image into this field will override the default image.

Selecting to upload a new image will direct you to a popup window, which gives the ability to browse and choose the desired image.

Note: Keep in mind that the system does not resize the image for this upload; after it has been uploaded the image may need to be resized, adjusted and reloaded as needed.

Setup System Look and Feel

Setup System Look and Feel allows you to configure the settings for the color of specific areas throughout the system. Changes applied to the System Look and Feel apply to all modules and all users.

After selecting this link, the master list of existing style sheets will display. You will have the ability to Edit existing selections, as well as Add new style sheet and Delete, as seen in the image below. You will also have the ability to apply created style sheets, as well as re-apply the Default Style Sheet that comes with the iRIS software.

Add a New Style Sheet will direct you to the following screen.

Style Sheet Name – Here the name for the sheet being created can be entered.

+ Icon for all tabs – Each of these areas allows you to designate the main color and background color for each area within the system.

Once a setup has been saved into the system it will be added to the master list. You can then choose to either Apply the Style sheet or Edit to make additional changes.

How these configurations affect iRIS – New Style Sheets applied to the system will allow you to control color display for areas in the system, including banners, headers, agenda items, form sections and questions, menu items, etc. The image below shows a new style sheet applied to the system that changed the color of the menu items on the homepage.

Modification Header

The modification header can be used to customize the background color and the color of the text when a stipulation is linked to a correction form sent to a Principal Investigator.  

Click the expand button to open the editor.

   Click Save when you are done to exit the editor and to apply the new color changes.  

How these configurations affect iRIS – The Modification Header will allow you to customize the highlighted and text color for portions of a stipulation linked to a correction form (Modification Form) sent to the study side. The image below shows a new style sheet applied to the system with the changed style of the modification Header.

Setup Event Type Details

Setup Event Type Details allows you to configure color-coding for system notifications. These settings apply on notifications that populate on users home screens when their account is set in classic mode.

After selecting this link, the master list of existing color selections will display. You will have the ability to Edit existing selections, as well as Add a new event type and Delete, as seen in the image below.

Add a New event type will direct you to the following screen.

Event Type – This required field provides a dropdown list of all of the available events / notifications that can be associated to a specific color.

Color – Designate the specific color.

Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – If a user has their account set to the modern view, the home screen will display the notifications according to the designated colors.

System Tutorials  

System Tutorials contains items that are specific to the User Interface Tutorial Steps and Module Tutorial. You can setup tutorials for different modules in the iRIS System. The tutorial is a step-by-step guide that shows and explains common areas of the system. This section is completely customizable. Please see the Iris Tutorial Manual for more details on how to setup the tutorials.

User Interface Tutorial Steps Setup

Setup User Interface Tutorial Steps – Allows the administrator to define steps for the different modules.

The User Interface Tutorial Steps Setup List is where you can create, edit, and delete individual steps in the tutorial. The Select the Module to Modify Step Description drop-down menu at the top of the page, allows you to choose the module you can edit the steps for.

Add a New Tutorial Step will direct you to the following screen.

Step Name - This must be the ID pulled from the developer tools. This is how the system knows what to refer to and highlight when creating the desired step. This is where the user will input the ID.   

Step Description - Users write a brief description of what the step is in order to tell similar ones apart. Part of it is also used in creating the actual tutorial (creating the step-by-step guide).  

Step Content (Step visible on UI) – This is a pre-define description of the step, already included in iRIS. Content that is visible on the UI means that the step that is referred to is physically on the iRIS home screen. 

Step Content (Step hidden on UI) – This is a pre-define description of the step, already included in iRIS. Content that is hidden on the UI means that the step that is referred to is not physically on the iRIS home screen, but still can be referred to as well. 

Customer Step Content (Step visible on UI) – This is a feature where customers can alter the language of the step that was already included in iRIS. There is a text editor where customers are able to add content that will be shown as part of the step instead of the iRIS pre-defined language. There are options to add links, pictures, special characters, and an option to print. 

Customer Step Content (Step hidden on UI) – This is a feature where customers can alter the language of the step that was already included in iRIS. There is a text editor where customers are able to add content that will be shown as part of the step instead of the iRIS pre-defined language. There are options to add links, pictures, special characters, and an option to print.

When completed, click Save Step Details, to save the step into the system.

Set-up Module Tutorials 

The Set-up Module Tutorials in iRIS is not available for all users, only a user who have purchased this section of iRIS can see the following link in their system. Please contact your Project Manager or Customer Support Representative if you have any questions regarding this link within this area.

User Profile Configuration(s)

User Profile Configuration(s) contains items that are specific to user’s accounts, as well as their account statuses. This area also contains the User Training Setup main configurations.

Institutional Role Name List

The Institutional Role Name List is used in the Annual COI Form and in a Covered Persons record within the COI review board. Institutional Role’s can be set up so the system can flag a certain user if they have a role that indicates a KDM or 990 requirements.

This configuration list will only be applicable if your system is configured for use with the Conflict of Interest module.

After selecting this link, the master list of existing records will display. You will have the ability to Edit existing Records, as well as Add a New Record and Delete, as seen in the image below.

The Order Number column determines not only how the roles are grouped here, but also in what order they appear within the Annual COI Form and in the list of roles when you assign a role to a user.

Is KDM? – Indicates whether or not the role is a Key Decision Maker.

Is 990? – Indicates whether or not the role falls under 990 criteria.

Display in COI Form – Indicates whether the role should display within the Institutional Roles data value within the Annual COI Form. This will allow a user to select their institutional roles.

You can download a template so that you can then upload your institutional roles, if your list of roles is extensive. Click the Download Role List Template button.

A new window will open, and your Internet browser will download the template. Internet Explorer Version 8 is used in this example. Depending on your Internet settings, you may have a blocker installed that prevents you from downloading files without approval. Wait a few moments and the browser may prompt you with a yellow bar at the top of the page. Click the yellow bar then select Download File from the menu that appears. Do this before clicking the Complete Checkout button. If you click Complete Checkout before saving the file to your desktop you will lose the file and will need to restart the process.

When you select to download the file, a popup window will ask you if you’d like to open or save the document. You can do either however we recommend that you save the document before opening. You will want to make sure you save the document to a location on your computer that you will remember.

When you choose to Save the document, you can browse your computer for the location you would like to save to.

Once this is complete, you need to click on the Complete Checkout button within the browser. If you did not want to check out the document, click the Cancel button. This will return you to the previous page without downloading the role list.

The Excel download is a simple template where you can enter Order Number and Roles and indicate YES or NO to columns C, D and E. When you are finished specifying this information; save the file and return to the Institutional Role configuration list.

Click the Upload Role List Code button.

Browse your machine for the Excel file location. Click Save selected file when you locate the file. You can click the Cancel button to cancel the upload.

When the roles are successfully uploaded, the system will alert you with a message. If for any reason the upload fails, the popup will inform you. Reasons for failure would be if you left any of the columns blank or added extra columns to the spreadsheet.

Any roles you uploaded will now appear in the list of roles.

You can add a new role to the list by clicking on the Add a New Role button.

A new page will open. Enter the Role Name and specify an Order Number.

You can also set flags for the role:

Is KDM? – Indicates whether or not the role is a Key Decision Maker. If a user has a role as KDM, certain triggers in the system can be set including COI triggers, Conflict of Commitment triggers and you can program branching in your COI Forms to branch down a certain path if the user filling out the form has a role with KDM flagged.

Is 990? – Indicates whether or not the role falls under 990 criteria. You can program branching in your COI Forms to branch down a certain path if the user filling out the form has a role with 990 flagged.

Display in COI Form – Indicates whether the role should display within the Institutional Roles data value within the Annual COI Form (see the above screenshot). This will allow a user to select their institutional roles.

When you are finished adding the details for the role, click the Save Role button and your role will be added to the list.

How these configurations affect iRIS – Within Search Conflict Matches in the COI Review Board, you are able to assign Institutional Roles to users.

Click the icon in the Open User Role column. This will open a page that lists the Institutional Roles and you can assign roles to the user.

Institutional Affiliations

Institutional Affiliations is a configurable list, which can be setup for users to associate to their profiles, when filling out the Profile information in My Assistant.

After selecting this link, the master list of existing records will display. You will have the ability to Edit existing Records, as well as Add a New Record and Delete, as seen in the image below.

Add a New Record will direct you to the following screen, where the Affiliation is required to designate the display name for this selection. Once a record has been saved in the system it will be added to the master list.

How these configurations affect iRIS – Within the My Account Information area of the My Assistant on the home screen. Users have the ability to enter additional information applicable to their account. Selecting the Profile brings the user to a screen where this information can be associated.

Note: System Administrators can also update this information in the User Accounts tool.

Representative Capacity

Representative Capacity is a configurable list, which can be setup for users to associate to their profiles, when filling out the Profile information of My Assistant.

After selecting this link, the master list of existing records will display. You will have the ability to Edit existing Records, as well as Add a New Record and Delete Record(s), as seen in the image below. Remember to select the checkbox to the left of the record that needs to be deleted, before selecting the delete button.

Add a New Record will direct you to the following screen, where the Representative Capacity is required to designate the display name for this selection. Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – Within the My Account Information area of the My Assistant on the home screen. Users have the ability to enter additional information applicable to their account. Selecting the Profile brings the user to a screen where this information can be associated.

Note: System Administrators can also update this information in the User Accounts tool.

Password Personal Questions

Password Personal Questions can be setup to further the security of user’s accounts.

After selecting this link, the master list of existing questions will display, if questions have previously been uploaded. You will have the ability to Edit the existing, as well as Add a New Personal Question and Delete, as seen in the image below.

Selecting to Add a New Personal Question will prompt you to enter the desired Question into the available field. Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – This information can be setup in the User Accounts area of System Administration. As long as this feature is turned on in your system, selecting the link for a user, will display the options to apply the Personal Question and Answer to the user’s account.

User Profile Status List

The User Profile Status List is a tool that allows you to Add or Edit a status that would be assigned to a user’s account. Whether an account is active, inactive or otherwise, the status can be associated to the account in the User Account area of System Administration. Some of these Statuses are hard coded and cannot be deleted, including Active, and Inactive. You can modify the names of the hardcoded status; you will not be able to delete the record from the system.

After selecting this link, the master list of existing records will display. You will have the ability to Edit the existing, as well as Add a New Status and Delete, as seen in the image below.

Selecting Add a New Status will prompt you to enter the Status Name, the preferred label the Status will display as. Saving the Status will add this name to the list of available Status for User Accounts. Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – The Status of a user account can be set in the User Accounts area of System Administration. Selecting the link for a user will bring you to an area where this information can be set.

Note: Any user account that is given the Inactive status will flag that user as no longer “Active” in the system. Any previous records associated to that user will remain intact but moving forward you will not be able to associate Inactive users to studies, review boards, conflict searches or subjects. Inactive users do not populate in reports unless the report is pulling historical data. They will also be excluded from searches in Find a Study.

User Education Training Setup

This area of the system will allow a System Administrator the ability to configure the main elements of the System User Education and Training.

Note: iRIS has the ability to interface with CITI Training. If your institution has purchased this interface, please be sure that any changes in this area of the system coincide with the configurations that will allow CITI to continue functioning with iRIS correctly. (i.e. courses in iRIS must exactly match the courses being imported from CITI. Courses will be created on the fly with the CITI Interface, if they do not already exist in iRIS – it is recommended to have the CITI Interface create the courses to be sure the courses used in iRIS are those imported via the CITI Interface).

Manage CITI Feeds

The Manage CITI Feeds link allows you to add multiple Primary and Secondary URL feeds. This method is used to import data from CITI Training into IRIS.

You can add a new feed to the list by clicking on the Add Feed Entry button. Selecting add feed entry will display a popup window, which will allow the user to enter two URLs within Primary and Secondary field.

Primary Feed – will pull data into iRIS using a CSV format. The Primary Feed will import all training records from CITI into iRIS.

Secondary Feed – will pull data into iRIS using a CSV format. The Secondary Feed will important any updates to the training records only.

After inputting the Primary and/or secondary URL(s), click on the Save Feed Entry to add the URL(s) to the main page, or Cancel to return to the CITI-Training Setup main page without adding a record. Once the URL(s) are inputted and saved, the Primary and/or Secondary feed(s) unique URL entered should populate in a table within the CITI-Training Setup page.

Define Training Courses

Define Training Courses allows you to configure / add or Edit all of the training courses that are applicable and unique to an institution. These courses can be associated to user accounts for users who have completed them in the user accounts area of System Administration.

After selecting this link, the master list of existing courses will display. You will have the ability to Edit the existing, as well as Add a New Training Course and Delete, as seen in the image below.

Selecting Add a New Training Course will prompt you to enter the Training Course Name. Saving the Course will add this name to the list of available Courses for association to User Accounts. Once a record has been saved into the system it will be added to the master list.

Note: Once this configuration is saved, it will be available to associate to user’s accounts as a course that has been completed or expired. Please see the IRB User Training Manual for additional details on configuring User Training within User’s Accounts.

Define Training Groups

Define Training Groups allows you to configure / add or Edit all of the training groups that would be applicable and unique to an institution. Additionally, Groups can be associated to courses as defined below.

After selecting this link, the master list of existing Groups will display. You will have the ability to Edit the existing, as well as Add a New Training Course Group and Delete, as seen in the image below. Remember to select the checkbox to the left of the record that needs to be deleted, before selecting the delete button.

Selecting Add a New Training Group will prompt you to enter the Training Group Name. Saving the Group will add this name to the list of available Groups for association to User Accounts.

Once a group name has been saved the page will refresh and the system automatically provides you with additional configurations.

Apply to all boards “By Name” – This area allows you to designate the Review Board to which this training group would apply.

Add a New Rule – This area allows you to configure rules that would apply for this group in relation to the courses that would or would not need to be completed for the group to be set as Active when associated to a User’s Account.

Selecting Add a New Rule will display a list of the available courses within iRIS.

Selecting Multiple Courses within the same rule will require that BOTH courses be complete (and not expired) for the rule to allow a user to be set as Active for that group. Once saved, the relation of the courses will display together, as seen below.

Selecting a single course when creating two separate rules will require that either course be complete (and not expired) for the rule to allow a user to be set as Active for that group, rather than both courses. Once saved, the relation will display with an OR relationship, as seen below.

Once the group and the rules to be associated have been saved into the system it will be added to the master list.

Define Training Group Assignments

Training Groups have the ability to have Assignments / Rules created and associated to them, in order to assign training based on specific answers and values within a submission. Although this tool is available, it is highly recommended that you use the System Workflow Designer tools to apply the rules and group association for users when they’re making submissions. The System Workflow Designer tool can be setup to function much the same way, but with additional features as the Define Training Group Assignments tool. Please refer to the Workflow Designer Manual for additional details regarding these configurations.

Upload User Training Record

Upload User Training Records allows you to easily upload an Excel file with as many training records for as many users as needed.

Download User Training Record Template – This feature allows you to download a spread sheet template. This template is setup in the proper format for uploading user training records, with instructions for the input of data in each field. When downloading, be sure to save the file to your Desktop, so you can input the data and save for future uploading.

Upload User Training Record – Selecting to Upload the Record will display a popup window, where you will be able to browse for the correct Excel file containing the Training records you wish to upload.

User Groups Setup

This area of the system will allow a System Administration the ability to configure User Groups for Research / Study users, which can be associated to Studies and other areas of the system as needed.

This functionality is only available if the property system.use_user_groups is configured with in System Administration -> System Configuration -> System User Profile Settings.

List Configuration(s) for Boards

List Configuration(s) for Boards allows you to configure areas of the system that are application to specific review boards.

IRB

This portion of the List Configuration(s) for Boards covers the IRB specific items, if additional modules have been purchased and turned on in your system, they will also display in this list. The setup for any additional modules should be found in that modules specific System Administration Manual.

Drug Configuration List

The Drug Configuration List allows you to configure / add or Edit all of the Drugs within iRIS.

After selecting this link, the master list of existing Drugs will display. You will have the ability to Edit existing Drugs as well as Download / Upload Drug Configurations, Merge Drug Records, Add a New Drug and Delete, as seen in the image below.

Additionally, this page contains a Search By filter, this filter allows you to search for specific drugs, which have been previously added.

Add a New Drug

Add a New Drug will prompt you to enter one of the following three fields. None of these fields are required, but at least one of the three must be entered. Saving this information will add the record to the master list of drugs within iRIS.

Download/Upload Drug

Download/Upload Drug Features gives you the ability to easily upload an Excel file with as many drug records as needed at one time.

Download Drug Configuration Template – This feature will allow you to download a spreadsheet template. This template is setup in the proper format for uploading Drug records, with instructions for the input of data in each field. When downloading, be sure to save the file to your Desktop, so the data can be input and saved for future uploading. Below you will find a screen shot of this spreadsheet template.

Upload Drug Configuration– Selecting to Upload the Record will display a popup window, where you will be able to browse for the correct Excel file containing the Drug records you wish to upload.

Merge Drug Records

Merge Drug Records Feature this feature will allow you to merge duplicate records within the system without adversely affecting study records related to the drugs to be merged.

After making this selection a list of the existing records will populate. Selecting two or more records will allow you to merge and select the record that you wish to keep.

Note: For records already existing on Studies, the record that you selected to keep will apply to all studies with the deleted drug.

How these configurations affect iRIS – Once Drugs have been added to the master list, they become available to be associated to study Applications through a data value.

Selecting to Add a New Drug to the Study will display a popup window, which will allow the user to search for the applicable drug.

If the board approves a submission with an attached drug, the drugs applicable to the submission then display as approved in the Study Management area for that particular study.

If any new drugs need to be added, or existing drugs need to be modified, the study will need to submit an amendment or modification to the review board of record for approval. Any modifications or new drug requests will populate in the Pending Drugs table, shown in the image below. Once the review board approves the modification or addition, the drug record will populate in the Approved Drugs table.

Device Configuration List

The Device Configuration List allows you to configure / add or Edit all of the Devices within iRIS that would be available to be associated to a Study.

After selecting this link, the master list of existing Devices will display. You will have the ability to Edit existing Devices as well as, Download / Upload Device Configurations, Merge Device Records, Add a New Device and Delete, as seen in the image below.

Additionally, this page contains a Search By filter, this filter allows you to search for specific Devices that have been previously added.

Add a New Device

Add a New Device will prompt you to enter the one of the following three fields, only the first field “Device Name” is required. Saving this information will add the record to the list of devices within iRIS.

Download/Upload Device

Download/Upload Device Features gives you the ability to easily upload an Excel file with as many device records as needed at one time.

Download Device Configuration Template – This feature will allow you to download a spreadsheet template; this template is setup in the proper format for uploading device records, with instructions for the input of data in each field. When downloading, be sure to save the file to your Desktop, so the data can be input and saved for future uploading. Below you will find a screen shot of this spreadsheet template.

Upload Device Configuration– Selecting to Upload the Record will display a popup window, where you will be able to browse for the correct Excel file containing the Device records you wish to upload.

Merge Device Records

Merge Device Records Feature this feature will allow you to merge duplicate records within the system.

After making this selection a list of the existing records will populate. Selecting two or more records will allow you to merge and select the record that you wish to keep.

Note: For records already existing on Studies, the record that you selected to keep will apply to all studies, which had the deleted record applied.

How these configurations affect iRIS – Once Devices have been added to the master list, they become available to be associated to study Applications through a data value.

Selecting Add a New Device to the Study will display a popup window, which will allow the user to search for the applicable device.

If the board approves a submission with an attached device, the device(s) applicable to the submission then display as approved in the Study Management area for that particular study.

If any new devices need to be added, or existing devices need to be modified, the study will need to submit an amendment or modification to the review board of record for approval. Any modifications or new device requests will populate in the Pending Approval table, shown in the image below. Once the review board approves the modification or addition, the device record will populate in the Approved Devices table.

Other Configuration(s)

The last group within the System Setup tab contains a list of other configuration lists available in the system. These lists allow you to configure details for medical licenses, publications, define a security policy that user’s must agree to. You can create a library of operating procedures, training material and general help that will be available to all users. You can also define help links that will appear in the first three sections of the Study Shell and Project Shell screens.

License Type List

License Type List is a configurable list, which can be setup for users to associate to their license, when filling out the Medical License information in their profile of My Assistant.

After selecting this link, the master list of existing records will display. You will have the ability to Edit existing types, as well as Add a New Type and Delete, as seen in the image below.

Add a New Type will direct you to the following screen, where the Type Name is required to designate the display name for this selection. Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – Within the My Account Information area of the My Assistant on user’s home screen. Users have the ability to enter additional information applicable to their account. Additionally, Medical Licenses can be uploaded and defined here.

Selecting Add License brings the user to a screen where this information can be associated. This area also contains the dropdown, which has the list of License Types which are available to be designated, based on the configurations done from the section above.

Note: System Administrators can also update this information in the User Accounts tool.

Publication Type List

Publication Type List is a configurable list, which can be setup for users to associate to their publications, when filling out the Biosketch, CV, Pubs information in their profile of My Assistant.

After selecting this link, the master list of existing records will display. You will have the ability to Edit existing types, as well as Add a New Type and Delete, as seen in the image below.

Add a New Type will direct you to the following screen, where the Type Name is required to designate the display name for this selection. Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – Within the My Account Information area of the My Assistant on user’s home screen. Users have the ability to enter additional information applicable to their account. Additionally, Biosketch, CV, and Publications can be uploaded and defined here.

Selecting to Add Publication brings the user to a screen where this information can be associated. This area also contains the dropdown which has the list of Publication Types which are available to be designated, based on the configurations done from the section above.

Note: System Administrators can also update this information in the User Accounts tool.

Define Security Policy

This option gives you the ability to setup a Security Policy, which when enabled; users will be required to agree to the next time they log into iRIS.

After selecting this link, the current settings for the security policy will display.

Use System Security Policy? – Provides the ability to turn this feature on or off in the system.

Text Editor – Will allow you to enter the text that you want the users presented with the next time they log into the system.

Save Security Policy – Once this has been saved, the system will provide you with a pop-up window, indicating that the information has been saved and asking if you want the users to be presented with the security policy again.

Selecting Cancel will save the changes and allow users to login as normal.Selecting OK will save the changes, and prompt users to re-acknowledge the policies the next time they log into iRIS. If user selects NO they will not be to login into iRIS and will be redirected to the login screen.

Operating Procedures Administration

Operating Procedures is a link that is available on a User’s end, which should contain the operating procedures that would be unique to your institution. This area is completely configurable as it was created for internal purposes, and should contain your unique operating procedures.

After selecting this link, the master list of existing Operating Procedures will display. You will have the ability to Edit existing records, as well as Add a New Operating Procedure and Delete, as seen in the image below.

Additionally, this page contains several Search By filters, these filters allow you to search for specific records which have been previously added.

Add a New Operating Procedure will direct you to the following screen.

The following are required in the above screen.

Operating Procedure Group – In this required field a previously created group can be selected, or a New Group can be added. The system will group the entries together on a user’s end.

Operating Procedure Title – In this required field the title you want the procedure displayed as.

Operating Procedure Order – In this required field the order in the group that you want the procedure displayed in.

Select the Location of the content for the Operating Procedure – Here you are required to select how you want this information pulled into iRIS; whether through a URL, Uploaded attachment, or simply entered text.

Once a record has been saved into the system it will be added to the master list.

How these configurations affect iRIS – Users can find the Operating Procedures that have been uploaded in their My Assistant drop down on the home screen.

Predefined Study Help Links

Predefined Study Help Links is a tool that is tied to the Study Shell for New Studies. When creating a new study or a new application, users are always directed to fill out 3 required sections: section 1.0 of the application - General Information (Study Title and Number), Section 2.0 of the application – Associating applicable Departments, and Section 3.0 of the application – Associating applicable Key Study Personnel. Help links can be applied to each of these sections of the application and are defined here.

After selecting this link, the list of existing Help Links (If any) will display. You will have the ability to Edit existing Links, as well as Add Help Link and Delete, as seen in the image below.

Add Help Link will direct you to the following screen.

The following are required in the above screen.

Select a Section – This dropdown allows you to select which of the 3 sections at the beginning of the application you want the Help Link to be applied to.

Select a Question – This dropdown allows you to select a question within that section, that you want the Help Link to be applied to.

Help Order – This allows you to set the order that you would like the help links to display in.

Help Tip – When the user holds their cursor over the help link the text entered here will display for them, before they actually click on the link.

Select the Type of Help Link – Within this area you are required to select the type of information that you want associated with the help link; whether this be a URL, or simply text that you want available to your users.

Once a record has been saved into the system it will be added to the list.