The iRIS™ system provides numerous picklists on system pages and forms. Some of these lists exist to save users the time and trouble of manually typing in frequently used data items. Other lists exist to enforce data validation requirements.

Lists are managed on the List Maintenance Setup tab. To access this area navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab.

This manual provides details of list configuration processes and settings, and where applicable, information about where the configured lists are employed in the iRIS™ system.

Navigation in iRIS™

iRIS™ includes two standard navigation tools on all pages nested one or more levels beneath the primary Workspace page of the module currently in use (e.g., Study Assistant, Conflict of Interest Assistant, Animal Resource Center, etc.): a Path directory tree, and Back buttons.

Path Directory Tree

The Path item at the upper left of iRIS™ pages provides a hyperlinked menu directory tree, allowing the user to quickly navigate back through the path they followed to get to their current location. Path appears on all pages nested at least one level beneath the main workspace

In the example shown the user is viewing the Broadcast Notice Add a new notice page. This page is nested three levels beneath the main workspace page, as indicated by the three links available in the Path directory tree: Home, board admin and broadcast notice.

Click on broadcast notice in the Path to navigate up one level in the directory tree, to the main Broadcast Notice page. There are now two levels in the Path directory tree: board admin and Home.

Click on board admin in the Path to navigate up one level in the directory tree, to the Board Administration page. There is now one level in the Path: Home.

Click on Home in the Path to navigate up one level in the directory tree, to the main Workspace page. No Path item is displayed here because the user is now at the top-most level of the directory tree.

Back Button

The second navigation tool is the Back button, which appears on all pages nested at least one level beneath the main workspace. The Back button takes the user to the same location as the last link shown in the Path.

In the example shown above, both the Back button and the broadcast notice link in the Path return the user to the Broadcast Notice page:

Clicking the Back button on the Broadcast Notice page returns the user to the Board Administration page, as indicated by the last link in the Path directory tree shown in the screenshot above.

Note that where the Back button appears on a page with editable fields or document upload controls, clicking the button before saving changes returns the user to the same location as the last link shown in the Path without saving changes.

Tools for Copying Board Configuration

The iRIS™ system provides tools for duplication of an existing review board’s configuration files to serve two different scenarios:

Download / Upload Board Configurations — create an identical board on a new server / in a new installation of the iRIS™ software

Copy Selected Configurations — create a new board on the same server / in an existing installation of the iRIS™ software with the same configuration settings as the source board

As shown in the screenshot below, both options are accessed via buttons on the List Maintenance Setup tab under IRB Assistant > Review Board Administration.

Note that these tools are only intended to be made available to full System Administrators (as opposed to those assigned to an Administrator role within a specific iRIS™ module) to help with initial setup of iRIS™ servers and new review boards.

Download/Upload Board Configurations

Download/Upload Board Configurations is a tool that allows full System Administrators (as opposed to those assigned to an Administrator role within a specific iRIS™ module) to duplicate a fully configured review board from one iRIS™ system to another, such as when setting up a new server at a new facility within the same umbrella institution, in order to avoid errors and save the time and effort of manually keying in all the same data for a new board.

CAUTION: Download/Upload Configurations should not be used in a live iRIS™ system. iMedRIS recommends performing a board configuration copy to a destination review board only once.

IN THE SOURCE iRIS™ SYSTEM: Click the Download Board Configurations button to download a file containing configuration settings for the currently selected IRB review board. A confirmation popup displays, as shown below.

Click CANCEL to close the popup without downloading the configuration file.

Click CONFIRM to complete the download. Note that as the popup indicates, the file is saved to the local computer’s Downloads folder.

ON THE TARGET iRIS™ SYSTEM: Copy the downloaded configuration file to the computer where the target iRIS™ system is installed. Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Upload Board Configurations button.

Click Cancel to close the popup without uploading the file.

Click Save selected file and follow the prompts to locate the file and upload it. Installation completes automatically.

Copy Configurations

Copy Configurations is a tool that allows an iRIS™ system administrator to copy pre-existing, fully configured review board elements into a different, newly created review board within the same iRIS™ system in order to avoid errors and save the time and effort of manually keying in all the same data for a new board.

CAUTION: Copy Configurations should not be used after setup of review boards is complete, nor in a live iRIS™ system. iMedRIS recommends performing a board configuration copy to a destination review board only once.

Note that configurations cannot be copied across review boards of different types (IRB to IBC, IRB to ARC, etc.). Within IRB Assistant it is only possible to copy configurations across IRB review boards.

Click the Copy Configurations button to copy a pre-existing IRB review board configuration to another IRB review board.

The Copy Review Board Configuration page displays. The page contains links to configurations that can be copied to another review board. Note the Destination dropdown list at the top center of the page, and the Helpful Information button at right. The Copy Configurations button is non-functional until the Destination and at least one configuration item are selected (details follow below).

Click the Helpful Information button to view a popup containing important information and warnings about copying review board configurations.

Click the close window button in the upper right corner (marked with a red asterisk) to close the popup.

Back on the Copy Review Board Configuration page, select the target review board from the Destination dropdown list at the top of the page. The configuration Source is shown at the upper left, indicating the review board that is currently active. Only review boards of the same type will populate in the Destination dropdown list.

Select boxes for applicable configuration items in the setup lists are now available.

Select the configuration item(s) to be copied to the selected destination by clicking the respective checkbox(es).

Note that the following configuration items of the Source board cannot be copied:

— Board Definition

— Setup Review Board Roles

— Role Access

— Setup Correspondence Template

— Review Cycle

— Study Status Configuration List

Click the Copy Configurations button to complete the copy process. Click the Cancel Copy button to cancel the process without saving changes.

When the Copy Configurations button is clicked the copy process completes, and the Copy Review Board Configuration page refreshes.

Items where there is no data to copy, or where the corresponding field is not turned on in the destination review board, are not copied to the Destination review board.

As demonstrated above, any items successfully copied are color coded with green text. Items that did not copy successfully are color coded with red text.

Note: When performing a review board configuration copy from one board to another, fields that were originally pre-populated in the destination board are overwritten with data copied from the source board.  

Adult Risk Assigned Configuration List

Where the property rb.use_adult_risk_assigned is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Study Board Properties, see screenshot below), the iRIS™ system allows for setup and maintenance of an Adult Risk Assigned Configuration List. The list contains current risk ratings the review board can assign to rate potential risk to adults accrued from participation in a particular study.

Setting the property to “Yes” populates an Adult Risk Assigned Configuration List link on the List Maintenance Setup tab, as shown in the example below.  

Click the link to open the Setup Adult Risk Assigned List page, shown below.

The page lists all previously configured adult risk assignments and provides controls for creating, revising and deleting adult risk assignment records.

The list defined here is used to populate the dropdown picklist for the Adult Risk Assigned field, which appears in both the Outcome tab (shown below) and Study Summary screen (not shown).

Add Adult Risk Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Adult Risk Assigned Configuration List link.

As shown below, the Setup Adult Risk Assigned List page opens.

Click the Add an Adult Risk button (blue box in screenshot above). An add form opens, as shown below.

Order Number defaults to “1” (one), meaning that this entry will appear at the top of the list on the Setup Adult Risk Assigned List page when saved. The field is unlocked, allowing for entry of a different Order Number. If a duplicate Order Number is entered here the list is automatically reordered, with the new item taking precedence.

Enter desired text for Adult Risk and Adult Risk Description, and click the Save Adult Risk button. The add form closes and the new Adult Risk is added to the list on the Setup Adult Risk Assigned List page.

Edit Adult Risk Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Adult Risk Assigned Configuration List link.

As shown below, the Setup Adult Risk Assigned List page opens.

Click the applicable icon in the Edit column (blue box in screenshot above). The selected record opens in an edit form, as shown below.

Make desired changes to Order Number, Adult Risk and Adult Risk Description.

If a duplicate Order Number is entered here the list is automatically reordered when changes are saved, with the new item taking precedence.

Click the Save Adult Risk button. The edit form closes and the Adult Risk is revised in the list on the Setup Adult Risk Assigned List page.

Delete Adult Risk Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Adult Risk Assigned Configuration List link.

As shown below, the Setup Adult Risk Assigned List page opens.

Click to select the checkboxes of the item(s) to be deleted in the far left column and click the Delete Selected Adult Risk(s) button (blue boxes in screenshot above).

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The item is deleted from the list on the Setup Adult Risk Assigned List page.

Adult Benefit Assigned Configuration List

Where the property rb.use_adult_benefit_assigned is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Study Board Properties), the iRIS™ system allows for setup and maintenance of an Adult Benefit Assigned Configuration List. The list contains current benefit ratings the review board can assign to rate potential benefits to adults accrued from participation in a particular study.

Setting the property to “Yes” populates an Adult Benefit Assigned Configuration List link on the List Maintenance Setup tab, as shown in the example below.  

Click the link to open the Setup Adult Benefit Assigned List page, shown below.

The page lists all previously configured adult benefit assignments and provides controls for creating, revising and deleting adult benefit assignment records.

The list defined here is used to populate the dropdown picklist for the Adult Benefit Assigned field, which appears in both the Outcome tab (shown below) and Study Summary screen (not shown).

Add Adult Benefit Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Adult Benefit Assigned Configuration List link.

As shown below, the Setup Adult Benefit Assigned List page opens.

Click the Add an Adult Benefit button (blue box in screenshot above). An add form opens, as shown below.

Order Number defaults to “1” (one), meaning that this entry will appear at the top of the list on the Setup Adult Benefit Assigned List page when saved. The field is unlocked, allowing for entry of a different Order Number.

If a duplicate Order Number is entered here the list is automatically reordered, with the new item taking precedence.

Enter desired text for Adult Benefit and Adult Benefit Description, and click the Save Adult Benefit button. The add form closes and the new Adult Benefit is added to the list on the Setup Adult Benefit Assigned List page.

Edit Adult Benefit Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Adult Benefit Assigned Configuration List link.

As shown below, the Setup Adult Benefit Assigned List page opens.

Click the applicable icon in the Edit column (blue box in screenshot above). The selected record opens in an edit form, as shown below.

Make desired changes to Order Number, Adult Benefit and Adult Benefit Description.

If a duplicate Order Number is entered here the list is automatically reordered when changes are saved, with the new item taking precedence.

Click the Save Adult Benefit button. The edit form closes and the Adult Benefit is revised in the list on the Setup Adult Benefit Assigned List page.

Delete Adult Benefit Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Adult Benefit Assigned Configuration List link.

As shown below, the Setup Adult Benefit Assigned List page opens.

Click to select the checkboxes of the item(s) to be deleted in the far left columns and click the Delete Selected Adult Benefit(s) button (blue boxes in screenshot above).

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The item is deleted from the list on the Setup Adult Benefit Assigned List page.

Ceded – Collaborating IRB List

Where the property rb.use_ceded_review_details is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Study Board Properties), the iRIS™ system allows for setup and maintenance of a Collaborating IRB List: a dropdown list of organizations provided in the Ceded to IRB field on the Outcome tab of a submission, as demonstrated below.

This field populates in the Outcome tab when the user indicates that the study has been ceded from or to another organization.

Setting the property to “Yes” populates a Ceded - Collaborating IRB List link on the List Maintenance Setup tab, as shown in the example below.  

Clicking the link opens the Setup Collaborating IRB List page, shown below.

The page lists all previously configured Collaborating IRB records and provides controls for creating, revising and deleting Collaborating IRB records.

Add Collaborating IRB Organization

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Ceded – Collaborating IRB List link.

As shown below, the Setup Collaborating IRB List page opens.

Click the Add an Organization button (blue box in screenshot above). An add form opens, as shown below.

Enter the desired text for the new Organization and click the Save Organization button. The add form closes and the new Organization is added to the list on the Setup Collaborating IRB List page.

Edit Collaborating IRB Organization

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Ceded – Collaborating IRB List link.

As shown below, the Setup Collaborating IRB List page opens.

Click the applicable icon in the Edit column (blue box in screenshot above). The applicable record is opened in an edit form, as shown below.

Revise text for the Organization as desired and click the Save Organization button. The edit form closes and the Organization is revised in the list on the Setup Collaborating IRB List page.

Delete Collaborating IRB Organization

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Ceded – Collaborating IRB List link.

As shown below, the Setup Collaborating IRB List page opens.

Click to select the checkboxes of the item(s) to be deleted in the far left columns and click the Delete Selected Organization(s) button (blue boxes in screenshot above).

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The Organization is deleted from the list on the Setup Collaborating IRB List page.

Ceded – Review Type List

The iRIS™ system allows for setup and maintenance of a Type of Review List: a dropdown list of review types provided in the Ceded to IRB Review Type field on the Outcome tab of a submission, as demonstrated below.

This field populates when the user indicates that the current IRB is not the IRB of Record and the study has been ceded to another IRB.

The Type of Review List is maintained on the Setup Type of Review List page, which is accessed via the Ceded – Review Type List link on the List Maintenance Setup tab, as shown in the example below.  

Clicking the link opens the Setup Type of Review List page, shown below.

The page lists all previously configured Type of Review records and provides controls for creating, revising and deleting Type of Review records.

Add Type of Review

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Ceded – Review Type List link.

As shown below, the Setup Type of Review List page opens.

Click the Add an Type of Review button (blue box in screenshot above). An add form opens, as shown below.

Enter the desired text for the new Type of Review and click the Save Type of Review button. The add form closes and the new Type of Review is added to the list on the Setup Type of Review List page.

Edit Type of Review

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Ceded – Review Type List link.

As shown below, the Setup Type of Review List page opens.

Click the applicable icon in the Edit column (blue box in screenshot above). The applicable record is opened in an edit form, as shown below.

Make desired changes to Type of Review text and click the Save Type of Review button. The edit form closes and the Type of Review is revised in the list on the Setup Type of Review List page.

Delete Review Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Ceded – Review Type List link.

As shown below, the Setup Type of Review List page opens.

Click to select the checkboxes of the item(s) to be deleted in the far left columns and click the Delete Selected Type of Review(s) button (blue boxes in screenshot above).

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The Type of Review is deleted from the list on the Setup Type of Review List page.

Pediatric Risk Assigned Configuration List

Where the property rb.use_child_risk_assigned is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Study Board Properties), the iRIS™ system allows for setup and maintenance of a Pediatric Risk Assigned Configuration List. The list contains current risk ratings the review board can assign to rate potential risk to minors accrued from participation in a particular study.

Setting the property to “Yes” populates a Pediatric Risk Assigned Configuration List link on the List Maintenance Setup tab, as shown in the example below.  

Click the link to open the Setup Pediatric Risk Assigned List page, shown below.

The page lists all previously configured adult risk assignments and provides controls for creating, revising and deleting adult risk assignment records.

The list defined here is used to populate the dropdown picklist for the Pediatric Risk Assigned field, which appears in both the Outcome tab (shown below) and Study Summary screen (not shown).

Add Pediatric Risk Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Pediatric Risk Assigned Configuration List link.

As shown below, the Setup Pediatric Risk Assigned List page opens.

Click the Add a Pediatric Risk button (blue box in screenshot above). An add form opens, as shown below.

Order Number defaults to “1” (one), meaning that this entry will appear at the top of the list on the Setup Pediatric Risk Assigned List page when saved. The field is unlocked, allowing for entry of a different Order Number. If a duplicate Order Number is entered here the list is automatically reordered, with the new item taking precedence.

Enter desired text for Pediatric Risk and Pediatric Risk Description, and click the Save Pediatric Risk button. The add form closes and the new Adult Risk is added to the list on the Setup Adult Risk Assigned List page.

Edit Pediatric Risk Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Pediatric Risk Assigned Configuration List link.

As shown below, the Setup Pediatric Risk Assigned List page opens.

Click the applicable icon in the Edit column (blue box in screenshot above). The selected record opens in an edit form, as shown below.

Make desired changes to Order Number, Pediatric Risk and Pediatric Risk Description.

If a duplicate Order Number is entered here the list is automatically reordered when changes are saved, with the new item taking precedence.

Click the Save Pediatric Risk button. The edit form closes and the Pediatric Risk is revised in the list on the Setup Pediatric Risk Assigned List page.

Delete Pediatric Risk Assigned

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Pediatric Risk Assigned Configuration List link.

As shown below, the Setup Pediatric Risk Assigned List page opens.

Click to select the checkboxes of the item(s) to be deleted in the far left column and click the Delete Selected Pediatric Risk(s) button (blue boxes in screenshot above).

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The item is deleted from the list on the Setup Pediatric Risk Assigned List page.

Regulatory Determination 1 List / Regulatory Determination 2 List

The Regulatory Determination 1 List and Regulatory Determination 2 List are used in the Outcome tab, to provide the IRB with preconfigured dropdown picklists of up to two regulatory determinations applicable to a given submission.

The configuration lists are accessed via the IRB Assistant > Review Board Administration > List Maintenance Setup tab > Regulatory Determination 1 List and Regulatory Determination 2 List links.

Clicking either link opens the associated Regulatory Determination List page (example, Regulatory Determination 1 List page, shown below).

Processes for adding, revising and deleting regulatory determination items are the same for both lists, as described in the following manual subsections.  

Add Regulatory Determination

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the applicable Regulatory Determination List link.

As shown below, the applicable Setup Regulatory Determination Assigned List page opens.

Click the Add a Risk Group button (blue box in screenshot above). An add form opens, as shown below.

Order Number defaults to “1” (one), meaning that this entry will appear at the top of the list on the Setup Regulatory Determination List page when saved. The field is unlocked, allowing for entry of a different Order Number. If a duplicate Order Number is entered here the list is automatically reordered, with the new item taking precedence.

Enter desired text for Regulatory Determination and click the Save Risk Group button. The add form closes and the new Regulatory Determination is added to the list on the applicable Setup Regulatory Determination List page.

Edit Regulatory Determination

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the applicable Regulatory Determination List link.

As shown below, the applicable Setup Regulatory Determination List page opens.

Click the Add a Risk Group button (blue box in screenshot above). An add form opens, as shown below.

Make desired changes to Order Number and Regulatory Determination and click the Save Risk Group button.

If a duplicate Order Number is entered here the list is automatically reordered when changes are saved, with the new item taking precedence.

The edit form closes and the Regulatory Determination is revised in the list on the applicable Setup Regulatory Determination List page.

Delete Regulatory Determination

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the applicable Regulatory Determination List link.

As shown below, the applicable Setup Regulatory Determination List page opens.

Click to select the checkboxes of the item(s) to be deleted in the far left column and click the Delete Selected Risk Group(s) button (blue boxes in screenshot above).

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The item is deleted from the list on the applicable Setup Regulatory Determination List page.

Archived Location List

Where the property rb.use_archived_location is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Study Board Properties, see screenshot below), the iRIS™ system provides a means for tracking locations where study documentation can be archived.

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Archived Location List link.

The Setup Archived Location List page is opened.

Archived Location List Implementation – Application Side

The archived location list is provided as a dropdown picklist on the Study Summary page for selection of Archived Location when a study/submission is renewed or reactivated, as shown in the IACUC example below.

Archived Location List Implementation – Board Side

Where applicable, archive locations are specified on the application side and are not generally subject to direct revision by the board.

Add Archived Location

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Archived Location List link.

The Setup Archived Location List page is opened. Click the Add a New Location button.

Enter the desired Archived Location and click the Save Location button.

The category is added on the main Setup Archived Location List page.

Edit Archived Location

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Archived Location List link.

The Setup Archived Location List page is opened. Click the icon in the Edit column for the applicable item.

The record is opened for editing. Make desired changes to the Archived Location field and click the Save Location button.

The category is revised on the main Setup Archived Location List page.

Delete Archived Location

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Archived Location List link.

The Setup Archived Location List page is opened. Select the checkbox(es) for the item(s) to be deleted and click the Delete Selected Location(s) button.

A confirmation popup window appears.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to delete the record and close the popup. The record is deleted from the list on the main Setup Archived Location List page.

Stipulation Category

Where the property rb.use_stipulation_category is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Recommendations and Stipulations), the review board can group stipulation items into categories.

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Stipulation Category link.

The Setup Stipulation Category List page is opened.

Stipulation Category List Implementation – Application Side

Where applicable, stipulations are assigned on the board review side. This list is not employed on the application side.

Stipulation Category List Implementation – Board Side

The stipulation category list is provided as a dropdown picklist for selection of Stipulation Type when a stipulation is added for a submission.

Add Stipulation Category

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Stipulation Category link.

The Setup Stipulation Category List page is opened. Click the Add a Stipulation Category button.

Enter a Stipulation Category name and click the Save Stipulation Category button.

The category is added on the main Setup Stipulation Category List page.

Edit Stipulation Category

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Stipulation Category link.

The Setup Stipulation Category List page is opened. Click the icon in the Edit column for the applicable item.

The record is opened for editing. Make desired changes to the Stipulation Category name and click the Save Stipulation Category button.

The category is revised on the main Setup Stipulation Category List page.

Delete Stipulation Category

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Stipulation Category link.

The Setup Stipulation Category List page is opened. Select the checkbox(es) for the item(s) to be deleted and click the Delete Select Stipulation Category(s) button.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The item is deleted from the Setup Stipulation Category List page.

Device Configuration List

The Device Configuration List is where a list of devices approved by the institution for use in animal subject studies is maintained in the iRIS™ system. To access the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Device Configuration List link.

The Setup Device List page is opened.

If the device list is lengthy, use the Device Browse/Find form above the list to search for records by Device Name.

Device List Implementation – Application Side

The device list is employed in the following areas on the application side of iRIS™.

Study Application — the Device Configuration List is made available in an application via an Add a New Device to the Study button

For more information about the study application, see the Study Assistant Manual.

Device List Implementation – Board Side

Devices are added on the application side where required and are not generally subject to direct revision by the board.

Add a New Device

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Device Configuration List link.

The Setup Device List page is opened. Click the Add a New Device button.

An Add a new device to the system panel opens for entry of the new record.

Enter a Device Name, Device Mode and Device Serial Number, then click the Save Changes button.

The add panel is closed and the new record is added on the Setup Device List page.

Download Device Configuration Template

The iRIS™ system provides a mechanism for adding a large quantity of device records at once, via population and upload of a pre-formatted Excel template. Click the Download Device Configuration Template button to begin. A download dialog opens at the bottom of the page.

Click the Cancel button in the download dialog popup to close it without downloading the template.

Click the Save button in the download dialog popup to save the template to the default Downloads folder on the computer. Click the upward-pointing arrow to the right of the Save button to access Save As options, which allow for saving the template to the user’s desired location on the computer.

The download dialog popup message changes when the download is complete, as shown below.

Navigate to the downloaded template file and open it.

As shown in the screenshot above, field length limits are provided in the second row. Enter desired device records to complete the template and save changes to the file.

Upload Device Configuration Template

When the Device Template has been populated with all desired data, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Device Configuration List link. The Setup Device List page opens. Click the Upload Device Configuration button.

An upload dialog popup appears.

Click the Cancel button to close the dialog without completing the upload.

Click the Browse… button to navigate to the completed template and select it, then click the Save selected file button to complete the upload.

Review the uploaded records in the Setup Device List page to ensure the uploaded records have correctly populated all columns. Any records that do not meet data content requirements must be edited or deleted promptly, to ensure they cannot be mistakenly assigned to studies.

Edit Device

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Device Configuration List link.

The Setup Device List page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an Edit a device in the system panel. Make desired changes and click the Save Changes button.

The edit panel is closed and the record is revised on the Setup Device List page.

Delete Device

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Device Configuration List link.

The Setup Device List page is opened. Click the icon in the Delete column for the applicable record.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record and return to the Setup Device List page.

Merge Device Records

Sometimes a duplicate or erroneous device record is created and then assigned to one or more study applications before the mistake is caught.

In that situation, the duplicate or erroneous device record can be merged with a valid device record. The valid device record is then substituted for the duplicate/erroneous device record previously assigned to study applications.

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Device Configuration List link.

The Setup Device List page is opened.

In the example shown above, the second “Cautery Pen” device record in the list was created in error but may have been assigned to one or more studies. Click the Merge Device Records button to begin. The Merge Device Records page opens.

Select the checkboxes at far left for the device records to be merged and click the Merge Selected Records button. A new panel opens with only the selected records listed.

Click the Cancel button to close the panel without merging the records.

Note the red instruction text above the table: select the radio button at far left for the record to be KEPT, then click the Merge button. A confirmation popup window appears.

As the popup states, all records on the list will be deleted except for the selected record. Click Cancel to close the popup without merging the records. Click OK to complete the merge and return to the Merge Device Records page, where the merge can be confirmed.

Drug Configuration List

The Drug Configuration List is where a list of drugs approved by the institution for use in studies is maintained in the iRIS™ system. To access the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Drug Configuration List link.

The Setup Drug List page is opened.

If the drug list is lengthy, use the Drug Browse/Find section above the list to search for records by Drug Name.

Drug List Implementation – Application Side

Where this field is in use by the institution, it appears in the study application form.

For more information about the study application, see the Study Assistant Manual.

Drug List Implementation – Board Side

Drugs are added on the application/study side where required and are not generally subject to direct revision by the board.

Add a New Drug

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Drug Configuration List link.

The Setup Drug List page is opened. Click the Add a New Drug button.

An Add a new drug to the system panel opens. Enter Trade Name, Generic Name and if not yet named, Investigational Name details, then click the Save Changes button to save the record and close the add panel.

The new drug is added on the Setup Drug List page.

Download Drug Configuration Template

The iRIS™ system provides a mechanism for adding a large quantity of drug records at once, via population and upload of a pre-formatted Excel template. Click the Download Drug Configuration Template button to begin. A download dialog opens at the bottom of the page.

Click the Cancel button in the download dialog popup to close it without downloading the template.

Click the Save button in the download dialog popup to save the template to the default Downloads folder on the computer. Click the upward-pointing arrow to the right of the Save button to access Save As options, which allow for saving the template to the user’s desired location on the computer.

The download dialog popup message changes when the download is complete, as shown below.

Navigate to the downloaded template file and open it.

As shown in the screenshot above, field length limits are provided in the second row. Enter desired drug records to complete the template and save changes to the file.

Upload Drug Configuration Template

When the Drug Template has been populated with all desired data, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Drug Configuration List link. The Setup Drug List page opens. Click the Upload Drug Configuration button.

An upload dialog popup appears.

Click the Cancel button to close the dialog without completing the upload.

Click the Browse… button to navigate to the completed template and select it, then click the Save selected file button to complete the upload.

Review the uploaded records in the Setup Drug List page to ensure the uploaded records have correctly populated all columns. Any records that do not meet data content requirements must be edited or deleted promptly, to ensure they cannot be mistakenly assigned to studies.

Edit Drug

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Drug Configuration List link.

The Setup Drug List page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an Edit a drug in the system panel.

Make desired changes and click the Save Changes button to save the record and close the edit panel. The record is revised on the Setup Drug List page.

Delete Drug

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Drug Configuration List link.

The Setup Drug List page is opened. Click the icon in the Delete column for the applicable record.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record and return to the Setup Drug List page.

Merge Drug Records

Sometimes a duplicate or erroneous drug record is created and then assigned to one or more study applications before the mistake is caught.

In that situation, the duplicate or erroneous drug record can be merged with a valid drug record. The valid drug record is then substituted for the duplicate/erroneous drug record previously assigned to study applications.

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Drug Configuration List link.

The Setup Drug List page is opened. Click the Merge Drug Records button.

In the example shown above, the “Motrin” drug record was created in error, as Motrin is another trade name for Ibuprofen and that drug is already in the list under the Trade Drug Name “Advil”. The Motrin record may have been assigned to one or more studies and must be merged with the “Advil” record. Click the Merge Selected Records button to begin. The Merge Drug Records page opens.

Select the checkboxes at far left for the drug records to be merged and click the Merge Selected Records button. A new panel opens with only the selected records listed.

Click the Cancel button to close the panel without merging the records.

Note the red instruction text above the table: select the radio button at far left for the record to be KEPT, then click the Merge button. A confirmation popup window appears.

As the popup states, all records on the list will be deleted except for the selected record. Click Cancel to close the popup without merging the records. Click OK to complete the merge and return to the Merge Drug Records page, where the merge can be confirmed.

Internal Document Category

The Internal Document Category list is where a list of standard, internal review board documents is maintained. To view the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Document Category link.

The Setup Board Internal Document Category List page is opened.

Internal Document List Implementation – Application Side

The internal document list is employed in the following areas on the application side of iRIS™.

Animal Procurement and Maintenance Information section — any supporting document(s) pertaining to animal subject adoption procedures can be added to an IACUC / ARC study in the Completed Experiment section of the application form

Funding Questions — any supporting document pertaining to funding can be added to a study in the Funding Questions section of the application form, as shown in the IACUC example below

Initial Review Submission Form — internal study documents can be attached to the application in the Other Study Documents section

Review Board Internal Documents — Review Board Internal Documents added to a study can be accessed on the application side via [module] > Find a Study > [study opened] > Study Management tab > Study Summary/Profile link > Study Management tab > Review Board Internal Documents link, as demonstrated in the IACUC example below

For more information about the study application, see the Study Assistant manual.

Internal Document List Implementation – Board Side

The internal document list is employed in the following areas on the review board / system setup side of iRIS™.

Review Board Internal Documents add form — board members can add internal documents via the Review Board Internal Documents add form

Add Internal Document Category

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Document Category link.

The Setup Board Internal Document Category List page is opened. Click the Add a Document Category button.

An add panel is opened for creation of the new record. Enter the new Document Category and click the Save Document Category button.

The record is added to the list on the main Setup Board Internal Document Category List page.

Edit Internal Document Category

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Document Category link.

The Setup Board Internal Document Category List page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an edit panel. Enter desired changes and click the Save Document Category button.

The record is revised on the main list page.

Delete Internal Document Category

 Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Document Category link.

The Setup Board Internal Document Category List page is opened. Select the checkbox in the far-left column for the applicable record and click the Delete Selected Document Category(s) button.

A confirmation popup window appears.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to delete the record and close the popup. The record is deleted from the list on the main Setup Board Internal Document Category List page.

Internal Routing User Roles

Where the property rb.useReviewRouting_user_role is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Submission Review Properties, see screenshot below), the iRIS™ system allows for setup and maintenance of an Internal Routing User Roles list, consisting of roles involved in study document review and signoff.

To access the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Routing User Roles link.

The Setup Internal Routing User Roles List page is opened.

Internal Routing User Role List Implementation – Application Side

The internal routing user role list is employed in the following areas on the application side of iRIS™.

Study Application — the internal routing user role dropdown is employed when making internal routing assignments for a submission

Study Application — the internal routing user role dropdown is employed in the Assign Reviewers section of the Pre-review Screening tab

Note that selection of an Ad Hoc reviewer role unlocks fields for selection of a named reviewer.

For more information about the study application, see the Study Assistant Manual.

Internal Routing User Role List Implementation – Board Side

The internal routing user role list is utilized during Pre-Review screening, as described in the previous section, and routing assignments made at that time are not generally subject to direct revision by the board.

Add Internal Routing User Role

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Routing User Roles link.

The Setup Internal Routing User Roles List page is opened. Click the Add a User Role button.

An add an internal routing user role panel is opened for creation of the new record. Enter the new User Role and click the Save User role button.

The add panel is closed and the record is added to the list on the Setup Internal Routing User Roles List page.

Edit Internal Routing User Role

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Routing User Roles link.

The Setup Internal Routing User Roles List page is opened. Click the icon in the Edit column for the applicable record.

An edit an internal routing user role panel is opened. Enter desired changes and click the Save User Role button.

The edit panel is closed, and the record is revised on the Setup Internal Routing User Roles List page.

Delete Internal Routing User Role

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Internal Routing User Roles link.

The Setup Internal Routing User Roles List page is opened. Select the checkbox(es) in the far-left column for the record(s) to be deleted and click the Delete Selected Role(s) button.

A confirmation popup window appears.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to delete the record and close the popup. The record is deleted from the list on the main Setup Internal Routing User Roles List page.

Member Specialty Configuration List

The Member Specialty Configuration List is where a list of review board member academic or medical specialties is maintained in the iRIS™ system. To access the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Member Specialty Configuration List link.

The System Administration – Member Specialty page is opened.

Member Specialty List Implementation – Application Side

The member specialty list is employed on the review board side only.

Member Specialty List Implementation – Board Side

Member specialties are added to review board member user profiles at the time the system administrator sets up their iRIS™ user accounts, and the specialty configuration list is also made available as a dropdown picklist when guests are added to the meeting attendance section for a meeting agenda (shown below).

Add Member Specialty

 Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Member Specialty Configuration List link.

The System Administration – Member Specialty page is opened. Click the Add a New Record button.

An add panel is opened. Enter the Specialty and click the Save Record button.

The record is added to the System Administration – Member Specialty list page.

Edit Member Specialty

 Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the click the Member Specialty Configuration List link.

The System Administration – Member Specialty page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an edit panel.

Make desired changes and click the Save Record button. The record is revised on the System Administration – Member Specialty list page.

Delete Member Specialty

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the click the Member Specialty Configuration List link.

The System Administration – Member Specialty page is opened. Click the icon in the Delete column for the applicable record.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record and return to the System Administration – Member Specialty list page. The record is deleted from the list.

Predefined Stipulations

The Predefined Stipulations list is where boilerplate stipulations approved by the institution for use in studies is maintained in the iRIS™ system. To view the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Predefined Stipulations link.

The Setup Stipulation page is opened.

Add Predefined Stipulation

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Predefined Stipulations link.

The Setup Stipulation page is opened. Click the Add a New Stipulation button.

The Add a stipulation to the system panel is opened.

Enter desired stipulation text in the Stipulation Content area. Use the toolbar buttons to format the text, insert links or insert images. Enter a numeric Order value to indicate routing priority order for the stipulation.

If stipulation categories are in use at the institution (property rb.use_stipulation_category set to “Yes” under IRB Assistant > Review Board Administration > Board Configuration Options > Recommendations and Stipulations) a Category field is also included at the top of the page, as shown below. Select the applicable Category from the dropdown list.

In the example below, the add panel is complete. Click the Save Stipulation button to save the new record and close the add panel.

The new stipulation is added on the main Setup Stipulation list page.

Edit Predefined Stipulation

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Predefined Stipulations link.

The Setup Stipulation page is opened. Click the icon in the Edit column for the applicable record.

The selected record is opened in an Edit a pre-defined system stipulation panel.

Note that if stipulation categories are in use at the institution (property rb.use_stipulation_category set to “Yes” under IRB Assistant > Review Board Administration > Board Configuration Options > Recommendations and Stipulations) a Category field is included in the edit panel.

Make desired changes and click the Save Stipulation button to save changes and close the edit panel. The record is updated on the Setup Stipulation list page.

Delete Predefined Stipulation

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Predefined Stipulations link.

The Setup Stipulation page is opened. Select the checkbox(es) in the far-left column for the record(s) to be deleted and click the Delete Selected Stipulation(s) button.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record and return to the Setup Stipulation page. The record is deleted from the Setup Stipulation page.

Review Outcome/Outcome Configuration List

The Review Outcome / Outcome Configuration list is where a list of predefined review outcomes is maintained in the iRIS™ system. To view the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Review Outcome / Outcome Configuration List link.

The Setup Board Review Outcome List page is opened.

Review Outcome List Implementation – Application Side

Review outcomes are generally assigned by the applicable review board, making this functionality inapplicable on the application side.

Review Outcome List Implementation – Board Side

The review outcome list is employed in the Outcome tab within submission processing screens, as shown in the IACUC example below.

Add Review Outcome

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Review Outcome / Outcome Configuration List link.

The Setup Board Review Outcome List page is opened. Click the Add a New Action button.

The add a review outcome panel is opened. Note that all fields default to a selection of “No”.

A selection of “Yes” for Response Required means that where this outcome is assigned, an application / submission will be returned and held from further progress until the required response is received.

A selection of “Yes” for Submission Copy Required means that where this outcome is assigned, a copy of the submission will be added to the Not Assigned queue. This option is typically used for tabled submissions that are to be assigned to a future meeting.

A selection of “Yes” for Use Sub-Workflow means that where this outcome is assigned, the system will trigger a sub-workflow that must be completed before submission for final approval.

Enter a Review Outcome and click to select “Yes” or “No” for Response Required, Submission Copy required and Use Sub-Workflow, then click the Save Review Outcome button.

The record is added on the main Setup Board Review Outcome List page.

Edit Review Outcome

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Review Outcome / Outcome Configuration List link.

The Setup Board Review Outcome List page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an edit a review outcome panel.

A selection of “Yes” for Response Required means that where this outcome is assigned, an application / submission will be returned and held from further progress until the required response is received.

A selection of “Yes” for Submission Copy Required means that where this outcome is assigned, a copy of the submission will be added to the Not Assigned queue. This option is typically used for tabled submissions that are to be assigned to a future meeting.

A selection of “Yes” for Use Sub-Workflow means that where this outcome is assigned, the system will trigger a sub-workflow that must be completed before submission for final approval.

Make desired changes and click the Save Review Outcome button.

The edit panel is closed, and the record is updated on the Setup Board Review Outcome List page.

Delete Review Outcome

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Review Outcome / Outcome Configuration List link.

The Setup Board Review Outcome List page is opened. Select the checkbox(es) in the far-left column for the record(s) to be deleted, then click the Delete Selected Action(s) button.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The popup closes and the record is deleted from the Setup Board Review Outcome List page.

Reviewer Rank Configuration List

The Reviewer Rank Configuration List is where a list of predefined reviewer ranks is maintained in the iRIS™ system. To view the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Reviewer Rank Configuration List link.

The Setup Reviewer Rank List page is opened.

Reviewer Rank List Implementation – Application Side

Reviewer ranks are generally assigned and tracked by the Coordinator and/or applicable review board, making this functionality inapplicable on the application side.

Reviewer Rank List Implementation – Board Side

The reviewer rank list is employed in the following areas on the review board / system setup side of iRIS™.

Study Application — the Reviewer Rank List is employed on the Pre-review Screening tab of the Initial Review Submission Packet, which is accessed via [module name] > Submissions > [submission opened for editing], as shown in the IACUC example below

If the reviewer rank selected in the Reviewer Role column is an Ad Hoc rank, additional fields populate in the Reviewer column for entry of the reviewer name.

Add Reviewer Rank

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Reviewer Rank Configuration List link.

The Setup Reviewer Rank List page is opened. Click the Add a New Rank button.

An add panel is opened for creation of the new record.

Enter a Reviewer Rank.  

Click to select “Yes” or “No” for Is this the label for an Ad Hoc reviewer. Note that the field defaults to “Yes”.

In the If this is not an Ad Hoc Review please add the Rank ( e.g., 1, 2, 3) field, enter a single digit from zero (0) through three (3). “0” indicates an Ad Hoc reviewer. “1” indicates a Primary Reviewer. “2” indicates a Secondary Reviewer. “3” indicates any other review level. “0” indicates Ad Hoc.

Note that if no entry is made in the If this is not an Ad Hoc Review please add the Rank ( e.g., 1, 2, 3) field a default value of “0” will be stored by the system, indicating this is an Ad Hoc Reviewer role.

Click the Save Reviewer Rank button to close the add panel. The record is added on the Setup Reviewer Rank List page.

Edit Reviewer Rank

 Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Reviewer Rank Configuration List link.

The Setup Reviewer Rank List page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an edit panel. Make desired changes and click the Save Reviewer Rank button.

The edit panel is closed, and the record is revised on the Setup Reviewer Rank List page.

Delete Reviewer Rank

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Reviewer Rank Configuration List link.

The Setup Reviewer Rank List page is opened. Select the checkbox(es) in the far-left column for the record(s) to be deleted and click the Delete Selected Rank(s) button.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The popup closes and the record is deleted from the Setup Reviewer Rank List page.

Invoice IRB Review Type

The iRIS™ system provides invoicing and accounting tools for use during processing of fee-based submissions. Categories for fee based review types are configured via the Setup Invoice IRB Review Type List page, shown below.

The configuration list is accessed via the IRB Assistant > Review Board Administration > List Maintenance Setup tab > Invoice IRB Review Type link.

Add Review Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Invoice IRB Review Type link.

As shown below, the Setup Invoice IRB Review Type List page opens.

Click the Add a Type of IRB Review button (blue box in screenshot above). An add form opens, as shown below.

Enter the desired text for the new Type of IRB Review and click the Save button. The add form closes and the new Review Type is added to the list on the Setup Invoice IRB Review Type List page.

Edit Review Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Invoice IRB Review Type link.

As shown below, the Setup Invoice IRB Review Type List page opens.

Click the applicable icon in the Edit column (blue box in screenshot above). The selected record is opened in an edit form, as shown below.

Revise the Type of IRB Review text as desired and click the Save button. The edit form closes and the Review Type is revised in the list on the Setup Invoice IRB Review Type List page

Delete Review Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Invoice IRB Review Type link.

As shown below, the Setup Invoice IRB Review Type List page opens.

Click to select the checkbox(es) of the type(s) to be deleted and click the Delete Selected Type of IRB Review(s) button (blue boxes in screenshot above). A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The popup closes and the record is deleted from the Setup Invoice IRB Review Type List page.

Waive Fee Option

Beginning with iRIS™ version 12.01, it is possible to waive invoice fees and maintain a configurable list of reasons for doing so. This functionality for situations where it is useful or necessary to generate an invoice for recordkeeping purposes, but no fee is to be charged. This feature is property based.

As shown below, six new properties have been added within the Fee tracking category under IRB Assistant > Review Board Administration > Board Configuration (red boxes in screenshot below).

The new properties are:

rb.show_rb_highest_review_level_on_invoice

rb.use_rb_invoicing_journal_fields_on_invoice

rb.use_rb_invoicing_review_level_on_invoice

rb.use_rb_invoicing_review_type

rb.use_rb_invoicing_review_type_on_invoice

rb.use_rb_invoicing_waive_fee

By default, “No” is selected for all of these properties. Invoicing must be enabled within the module by selecting “Yes” for the rb.use_rb_invoicing property in order for the new fields to function, as that property turns the entire invoicing feature off and on.

As demonstrated in the screenshot below, setting ALL SIX (6) properties to “Yes” adds a Waive Fee Y/N field, Reason for Waiving Fee field and auto-populating Percentage Waived field on the Submission Invoice page, and entries made there carry through to the submissions Pre-review Screening tab, below the Apply Fee for Service field.

Note that the Waive Fee and Reason for Waiving Fee fields remain active on the Pre-review Screening tab and can be updated there.

With the properties enabled, new fields populate on the Submission Invoice page as follows:

Waive Fee? — select “Yes” to waive the fee; this selection populates Reason for Waiving Fee? and Percentage Waived fields, as shown below

Reason for Waiving Fee? — click in the field to open a drop down pick list of reasons; click the desired item to select it, automatically populating the associated Percentage Waived? field

Setup Waive Fee Reason

The preconfigured list of acceptable reasons for waiving fees is maintained via the Setup Waive Fee Reason List page. To access the page, navigate to Review Board Administration > List Maintenance Setup > Setup Waive Fee Reason link.

Click the link to open the Setup Waive Fee Reason List page, shown below.

Previously configured Wave Fee Reasons are listed in a table. Buttons and controls are provided to add, edit or delete Waive Fee Reasons.

Add Waive Fee Reason

Navigate to Review Board Administration > List Maintenance Setup > Setup Waive Fee Reason link.

Click the link to open the Setup Waive Fee Reason List page, shown below.

Click the Add a Waive Fee Reason button (blue box in screenshot above). An add form opens, as shown below.

Enter the desired text for the new Waive Fee Reason and the desired Percent to Waive, then click the Save Waive Fee Reason button. The add form closes and the new Waive Fee Reason is added to the Waive Fee Reason list.

Edit Waive Fee Reason

Navigate to Review Board Administration > List Maintenance Setup > Setup Waive Fee Reason link.

Click the link to open the Setup Waive Fee Reason List page, shown below.

Click the applicable icon in the Edit column (blue box in screenshot above) to open the corresponding Waive Fee Reason record for editing. The record is opened in an edit panel, as shown below.

Make desired changes to the text for Waive Fee Reason and Percent to Waive, then click the Save button. The edit form closes and the Waive Fee Reason is revised in the Waive Fee Reason list.

Delete Waive Fee Reason

Navigate to Review Board Administration > List Maintenance Setup > Setup Waive Fee Reason link.

Click the link to open the Setup Waive Fee Reason List page, shown below.

Click to select the applicable checkbox(es) in the far left column (blue box in screenshot above) for the Waive Fee Reason record(s) to be deleted and click the Delete Selected Waive Fee Reason(s) button. A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The popup closes and the record is deleted from the Setup Waive Fee Reason List page.

Waive Invoice Option

Beginning with iRIS™ version 12.01, it is possible to waive the issuance of an invoice while still capturing fee data, and maintain a configurable list of reasons for waiving the issuance of the invoice.

Setup Waive Invoice Reason

The preconfigured list of acceptable reasons for waiving invoices is maintained via the Setup Waive Invoice Reason List page. To access the page, navigate to Review Board Administration > List Maintenance Setup > Setup Waive Invoice Reason link.

Click the link to open the Setup Waive Invoice Reason List page, shown below.

Previously configured Wave Invoice Reasons are listed in a table. Buttons and controls are provided to add, edit or delete Waive Invoice Reasons.

Add Waive Invoice Reason

Navigate to Review Board Administration > List Maintenance Setup > Setup Waive Invoice Reason link.

Click the link to open the Setup Waive Invoice Reason List page, shown below.

Click the Add a Waive Invoice Reason button (blue box in screenshot above). An add form opens, as shown below.

Enter the desired text for the new Waive Invoice Reason and click the Save Waive Invoice Reason button. The add form closes and the new Waive Invoice Reason is added to the Waive Invoice Reason list.

Edit Waive Invoice Reason

Navigate to Review Board Administration > List Maintenance Setup > Setup Waive Invoice Reason link.

Click the link to open the Setup Waive Invoice Reason List page, shown below.

Click the applicable icon in the Edit column (blue box in screenshot above) to open the corresponding Waive Invoice Reason record for editing. The record is opened in an edit panel, as shown below.

Make desired changes to the text for Waive Invoice Reason and click the Save button. The edit form closes and the Waive Invoice Reason is revised in the Waive Invoice Reason list.

Delete Waive Invoice Reason

Navigate to Review Board Administration > List Maintenance Setup > Setup Waive Invoice Reason link.

Click the link to open the Setup Waive Invoice Reason List page, shown below.

Click to select the applicable checkbox(es) in the far left column (blue box in screenshot above) for the Waive Invoice Reason record(s) to be deleted and click the Delete Selected Waive Invoice Reason(s) button. A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The popup closes and the record is deleted from the Setup Waive Invoice Reason List page.

Invoice Payment Type

A predefined list of invoice payment methods (e.g., cash, credit card, etc.) is maintained via the invoice payment type list, which is maintained via the Setup Board Invoice Payment Type List page. To access the page, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Invoice Payment Type link.

As shown below, the Setup Board Invoice Payment Type List page opens.

Previously configured Payment Types are listed in a table. Buttons and controls are provided to add, edit or delete Payment Types.

Add Invoice Payment Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Invoice Payment Type link.

As shown below, the Setup Board Invoice Payment Type List page opens.

Click the Add a New Payment Type button (blue box in screenshot above). An add form opens, as shown below.

Enter the desired text for the new Payment Type and click the Save button. The add form closes and the new Payment Type is added to the invoice Payment Type list.

Edit Invoice Payment Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Invoice Payment Type link.

As shown below, the Setup Board Invoice Payment Type List page opens.

Click the applicable icon in the Edit column (blue box in screenshot above) to open the corresponding Payment Type record for editing. The record is opened in an edit panel, as shown below.

Make desired changes to the Payment Type text and click the Save button. The edit form closes and the Payment Type is revised in the invoice Payment Type list.

Delete Invoice Payment Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Invoice Payment Type link.

As shown below, the Setup Board Invoice Payment Type List page opens.

Click to select the applicable checkbox(es) in the far left column (blue box in screenshot above) for the Payment Type record(s) to be deleted. A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record and return to the Setup Protocol Document Outcome page.

Click CONFIRM to complete deletion of the record. The Payment Type is deleted from the Setup Board Invoice Payment Type List page.

Setup Review Board Stipulation Actions

The Review Board Stipulation Actions List is where a list of boilerplate review board stipulation actions approved for use in studies is maintained in the iRIS™ system.

These actions are applied to stipulations when a study submits its response to the review board. Review board stipulation actions determine if the incoming stipulation can be closed as complete or must be retained as an outstanding item to the study.

To view the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Setup Review Board Stipulation Actions link.

The Setup Stipulation Review Board Actions page is opened.

Add Review Board Stipulation

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Setup Review Board Stipulation Actions link.

The Setup Stipulation Review Board Actions page is opened. Click the Add a Stipulation Action button.

An add panel is opened for creation of the new record.

The Automatically Copy Stipulation from Previous Submission to Current Submission setting controls whether the stipulation is to be closed as completed or copied to the current submission and remain as an outstanding item to the study. “No” indicates the stipulation is to be closed. “Yes” indicates the stipulation will remain as an outstanding item to the study.

The Default Stipulation Review Outcome when the Submission is Complete selection dictates whether a closed status is to be automatically assigned to the stipulation. Click the Save Stipulation Action button to add the record to the list.

Complete the form as desired and click the Save Stipulation Action button.

The record is added to the Setup Stipulation Review Board Actions list page.

Edit Review Board Stipulation

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Setup Review Board Stipulation Actions link.

The Setup Stipulation Review Board Actions page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an edit panel. Make desired changes and click the Save Stipulation Action button.

The edit panel is closed, and the record is revised on the Setup Stipulation Review Board Actions list page.

Delete Review Board Stipulation

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Setup Review Board Stipulation Actions link.

The Setup Stipulation Review Board Actions page is opened. Select the checkbox(es) in the far-left column for the record(s) to be deleted and click the Delete Selected Stipulation Action(s) button.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record and return to the Setup Stipulation Review Board Actions page.

Click CONFIRM to complete deletion of the record and return to the Setup Stipulation Review Board Actions page. The record is deleted from the Setup Stipulation Review Board Actions page.

Setup Training Courses

Direct access to the Define Training Courses area under iRIS™ System Administration > List Configuration and Maintenance > System Setup tab > User Training Setup section is provided for the review board under IRB Assistant > Review Board Administration > List Maintenance Setup tab > Setup Training Courses link.

See the List Configuration and Maintenance section of the System Administration – User Training Manual for more information about configuring and tracking iRIS™ user training.

Business Associate List

The Business Associate List link is used to access system functions related to business associates. In this context, a business associate is an institution or business which interacts with the institution where iRIS™ is in use.

Within the iRIS™ system, business associate entities can be added as a study sponsor, vendor or subrecipient, or as a third party in a conflict of interest.

For more information about business associate list management activities, see the Business Associate List manual.

Sponsor Type

The Sponsor Type configuration list is where a list of predefined sponsor types is maintained in the iRIS™ system. To view the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Sponsor Type link.

The Setup Sponsor Type page is opened.

Sponsor Type Implementation: Application Side

The sponsor type list is employed when a sponsor is added to the study application via the Add a New Sponsor to the Study button. As shown below, any sponsor listed in the table beneath the add button includes the Sponsor Type designation selected when the sponsor is added to the application.

Sponsor Type Implementation: Board Side

The sponsor type list is employed in the System Setup of Business Associate List page, as shown below.

When “Sponsor” is selected from among the Associate Group options (large red arrow in screenshot above), new fields populate for selection of the sponsor type (small red arrow and red box in screenshot above) and entity details.

Add Sponsor Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Sponsor Type link.

The Setup Sponsor Type page is opened. Click the Add a New Category button.

An add panel is opened for creation of the new record.

Enter a Sponsor Type name. At some institutions a numeric code is included in the name, as shown in the previous screenshot. The name should be distinct from any pre-existing items in the configuration list.

Enter the desired Sort Order Number. This number specifies the order in which sponsors appear in the configuration list and dropdown picklist of sponsors.

Note: If a number that is already in use is selected, when this record is saved its Sort Order Number overrides any pre-existing item with the same sort order. The overridden item and all items that follow it in the list are incremented by one (1) and moved down one (1) position in the configuration list.

Select “Yes” or “No” for Include Sponsors of this group in Disclosure Search field.

Enter a Description of the sponsor to assist system users in distinguishing it from other sponsors in the list.

An example of the filled add panel is shown below. Click the Save Category button.

The record is added on the Setup Sponsor Type page.

Edit Sponsor Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Sponsor Type link.

The Setup Sponsor Type page is opened. Click the icon in the Edit column for the applicable record.

The selected record is opened in an edit panel. Make desired changes to the fields in the panel.

At some institutions a numeric code is included in the Sponsor Type name, as shown above. The name should be distinct from any pre-existing items in the configuration list.

The Sort Order Number specifies the order in which sponsors appear in the configuration list and dropdown picklist of sponsors.

Note: If a number that is already in use is selected, when this record is saved its Sort Order Number overrides any pre-existing item with the same sort order. The overridden item and all items that follow it in the list are incremented by one (1) and moved down one (1) position in the configuration list.

Select “Yes” or “No” for Include Sponsors of this group in Disclosure Search field.

Enter a Description of the sponsor to assist system users in distinguishing it from other sponsors in the list.

Click the Save Category button to save changes.

The record is revised on the Setup Sponsor Type page.

Delete Sponsor Type

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Sponsor Type link.

The Setup Sponsor Type page is opened. Click the icon in the Delete column for the applicable record.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The record is deleted from the list on the Setup Sponsor Type page.

Risk Assigned Configuration List

Where the property rb.use_risk_assigned is set to “Yes” (under IRB Assistant > Review Board Administration > Board Configuration Options > Study Board Properties, see screenshot below), the iRIS™ system allows for setup and maintenance of a Risk Assigned Configuration List. The list contains current risk ratings the review board can assign to studies.

Setting the property to “Yes” populates a Risk Assigned Configuration List link on the List Maintenance Setup tab, as shown in the example below.  

The list defined here is available for assigning risk to a study within the Outcome tab of the submission processing screens, as shown below.

Add Risk

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Risk Assigned Configuration List link.

As shown below, the Review Board Risk Assigned page opens.

Click the Add a New Record button. An add form opens, as shown below.

Enter desired text for Risk Assigned and click the Save Record button. The add form closes and the new Risk is added to the list on the Review Board Risk Assigned page.

Edit Risk

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Risk Assigned Configuration List link.

As shown below, the Review Board Risk Assigned page opens.

Click the applicable icon in the Edit column. The applicable record is opened in an edit form, as shown below.

Revised the Risk Assigned text as desired and click the Save Record button. The edit form closes and the new Risk is revised in the list on the Review Board Risk Assigned page.

Delete Risk

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Risk Assigned Configuration List link.

As shown below, the Setup Adult Risk Assigned List page opens.

Click the Delete column icon for the item to be deleted.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The item is deleted from the list on the Review Board Risk Assigned page.

Study Document Outcome/Outcome Configuration List

The Document Outcome/Outcome Configuration List is where a list of boilerplate outcome statuses approved for use in studies is maintained in the iRIS™ system. To view the list, navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Study Document Outcome / Outcome Configuration List link.

The Setup Protocol Document Outcome page is opened.

Note that at some institutions, the term “Study” is substituted for “Protocol”. These terms may be used interchangeably in manual text and screenshots.

Study Document Outcome List Implementation – Application Side

Study document outcomes are assigned by the applicable review board, making this functionality inapplicable on the application side.

Study Document Outcome List Implementation – Board Side

The study document outcome list is employed in the following areas on the review board / system setup side of iRIS™.

Submission processing — the Study Document Outcome list is employed as a dropdown picklist in the Outcome field when approving a study document within submission processing screens, as shown in the IACUC example below

Add Study Document Outcome

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Study Document Outcome / Outcome Configuration List link.

The Setup Protocol Document Outcome page is opened. Click the Add a New Status button.

An add a review outcome panel is opened for creation of the new record. Below, the blank form is shown with the default selection of “No” in place for Create PDF.

When “Yes” is selected for Create PDF, indicating that the document given this outcome is to be converted to a PDF, three additional fields pertaining PDF settings are unlocked with default selections set to “No”.

Note that Create PDF must be set to “Yes” for any document to which an electronic document stamp will be applied.

Use Approved Stamp – This option is only available where the review board property “rb.stamp_study_doc” (under IRB Assistant > Review Board Administration > Board Configuration Options > Document Processing) is turned on. When this option is set to “Yes”, the study document PDF with this outcome assigned will have an electronic approval stamp applied.

Use Void Stamp – When this option is set to “Yes”, the study document PDF with this outcome assigned will have an electronic VOID watermark applied.

Start From Original Document - When this option is set to “Yes”, the assigned outcome is applied to the original document. When this option is set to “No”, the assigned outcome is applied to a PDF of the original document that was previously created as part of a prior outcome.  

This setting is useful in cases where the review board needs to revisit a study document and assign a different outcome. For example, when a PDF document with a VOID watermark is subsequently approved, Start from Original Document must be set to “Yes” to ensure the VOID watermark is removed from the document.

Fill the form as desired and click the Save Study Document Outcome button.

The outcome is added on the Setup Protocol Document Outcome list page.

Edit Study Document Outcome

Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Study Document Outcome / Outcome Configuration List link.

The Setup Protocol Document Outcome page is opened. Click the icon in the Edit column for the applicable record.

The record is opened in an edit a review outcome panel.

When “Yes” is selected for Create PDF, indicating that the document given this outcome is to be converted to a PDF, three additional fields pertaining PDF settings are unlocked with default selections set to “No”.

Note that Create PDF must be set to “Yes” for any document to which an electronic document stamp will be applied.

Use Approved Stamp – This option is only available where the Review Board Property “rb.stamp_study_doc” (under IRB Assistant > Review Board Administration > Board Configuration Options > Document Processing) is turned on. When this option is set to “Yes”, the study document PDF with this outcome assigned will have an electronic approval stamp applied.

Use Void Stamp – When this option is set to “Yes”, the study document PDF with this outcome assigned will have an electronic VOID watermark applied.

Start From Original Document - When this option is set to “Yes”, the assigned outcome is applied to the original document. When this option is set to “No”, the assigned outcome is applied to a PDF of the original document that was previously created as part of a prior outcome.  

This setting is useful in cases where the review board needs to revisit a study document and assign a different outcome. For example, when a PDF document with a VOID watermark is subsequently approved, Start from Original Document must be set to “Yes” to ensure the VOID watermark is removed from the document.

Edit the record as desired and click the Save Protocol Document Outcome button. The edit panel is closed, and the record is revised on the Setup Protocol Document Outcome list page.

Delete Study Document Outcome

 Navigate to IRB Assistant > Review Board Administration > List Maintenance Setup tab and click the Study Document Outcome / Outcome Configuration List link.

The Setup Protocol Document Outcome page is opened. Select the checkbox(es) in the far-left column for the record(s) to be deleted and click the Delete Selected Status(s) button.

A confirmation popup window displays.

Click CANCEL to close the popup without deleting the record.

Click CONFIRM to complete deletion of the record. The record is deleted from the Setup Protocol Document Outcome page.

Study Dashboard(s) Tab Allocation

The iRIS™ system allows institutions to configure the order in which study status tabs appear on study dashboards. Configuration of this feature is accessed via RB Assistant > Review Board Administration > List Maintenance Setup tab > Study Dashboard(s) Tab Allocation link.

See the Document Management manual for more information about this feature.