Please note: A PDF version of this guide is available for download at the bottom of the article.

Within IACUC Review Board Administration you can set up configuration lists, define Outcome Letters, define Meeting Agenda and Minutes templates, and setup automatic review board related notifications. Due to this high level of control, the Review Board Administration section of the IACUC Assistant module is typically reserved for Review Board Administrators.

System Setup

The first section of Review Board Administration is the System Setup tab. This section allows review board administrators to manage the general setup for the IACUC Assistant module. As a Review Board Administrator, you can define review board details, setup review board roles, and define board member access in iRIS. You can also create the templates for Outcome Letters, Minutes, and Agendas, as well as set up system-generated notices that will send to study or board users based on certain events in the system.

Copy Configurations

Note: This is a tool designed to help with the initial setup of iRIS. It is not recommended that this be used once your review boards are set up or once your system is live. This also must be used in conjunction with other IACUC review board modules. Configurations cannot be copied from review boards that are different types (IRB to IBC, IRB to IACUC) but can only be copied to review boards that are the same type (IRB to IRB, IBC to IBC, IACUC to IACUC).

If you have two review boards that have similar configurations, you can copy configurations that are set in one review board to another review board of the same type.

Click on the Copy Configurations button to get started.

A new screen will open, displaying the available configurations that can be copied to the other review board.

At the top of the page, the source is listed. This is the review board you are currently working in. You will need to select a Destination review board. Only review boards of the same type will populate in the Destination drop down list. When a destination is selected, checkboxes will populate next to each configuration option.

*Note: certain configurations of the IACUC cannot be copied:

• Board Definition
• Setup Review Board Roles
• Role Access
• Setup Correspondence Template
• Review Cycle
• Study Status Configuration List

Select the checkbox next to the configuration items that you would like to copy to the other review board. If you do not wish to proceed, click the Cancel Copy button to return to the Review Board Administration list. To proceed with the copy, click the Copy Configuration button.

The screen will refresh and update. Any item successfully copied will turn green, and items that did not copy successfully will turn red. An item may not copy over if there is no data in the first place or if that field is not turned on in the destination review board.

Note: when performing a copy from one board to another, if any field is populated in the destination board, it will be overwritten.  

Good practice for successful copying is to have each item in the source review board completely configured and ready to copy so you only copy one time. iMedRIS recommends only performing the copy one time to the destination review board.

Board Definition

The first item in the Review Board System Setup list is the Board Definition.

This page allows you to specify details regarding the review board. There are two required information fields: Review Board Name and Review Board Type. The Review Board Type is a list of predefined board types as specified in your contract with iMedRIS Data Corporation. For more information on the different types of available review boards, please contact iMedRIS. This list will be grayed out on this page, as the review board type has already been defined.

You can enter or edit information about the Assurance Number and Assurance Expiration, any Comments, and contact information for the review board. After updating or changing this information, click the Save Definition button on the top right of the page.

Board Configuration Options

This page lists some of the features that you can set within the Review Board. Before changing these properties it is a good idea to have a working knowledge of your system and of any potential changes. It is also good to verify changes with iMedRIS personnel before applying them to a live system.

The properties are divided into categories and these categories are displayed on the left panel of the screen. To view the properties in a category, click the category in the left panel, and all the properties related to that category will display. The ‘Yes’ and ‘No’ radio buttons indicate that the properties are on/off. Any other value indicates that the property is a variable.

Please see the IACUC Properties manual for specific information related to each property.

You can use the Download Properties Script button to download a .sql script containing the configurations for the review board properties, which can be used to import the configurations into another iRIS system.

Broadcast Notice

Broadcast Notice is a tool that will allow you to send an email to review board members and users associated to the review board (users on studies that are associated to the review board). Use this tool from within the review board to send out alerts and messages that pertain to this group of users. There is another Broadcast Notice that can be set up and sent from System Administration, however, this will send to all users in iRIS.

When you open the Broadcast Notice page, the system will display any broadcasts previously set up/sent out. The first time you open this page, the page will be empty.

Click on the Add a New Notice button.

A new page will open, allowing you to provide a Subject for the notice, enter the Content, and attach any documents, if necessary.

Click on the Return to List button to cancel and return to the list of broadcast notices.

If you have started the broadcast notice but are not ready to send it as an email yet, you can save the notice without sending by clicking on the Temp Save Notice button. Doing this will save the notice and return you to the list of broadcast notices. You can return to the notice by locating it in the list of notices and then clicking on the Edit/View icon.

Within the detail of the notice, only the Subject line is required. This is so that you can temporarily save your notice without any detail provided in the Content section. You can type in the Content, or copy and paste.

If you need to attach a document to the notice, click on the Add a new Attachment button.

A new page will open. Enter the Title of the document and click the Upload button to search your computer for the document you wish to upload. 

Once you upload a document, the page will refresh and display an icon to the left of the Title. Click the Save and Return button to associate the document to the notice. 

The associated document will display in a table in the Attachments area. You can add multiple attachments to the broadcast; however, your email server may have a restriction on the max file size for documents attached to outgoing emails. You may want to check with your email administrator on any limitations before sending large documents through the broadcast. You can remove an associated document by selecting the checkbox next to the document and then click the Delete Selected Attachment(s) button. 

Once you have defined the Subject, entered Content, associated any necessary documents, and are ready to send the broadcast notice, click on the Send button. A small popup window will open, allowing you to choose the recipients of the broadcast notice. *Note, when you click Send, and the popup displays, iRIS defaults the first selection, “Send to KSPs and review board members”. To change the recipients of the email, uncheck this option, and the two other options will display. Make your selection and click Send within the popup window, or click Cancel to exit without sending.

You will then be returned to the list of broadcast notices. Your broadcast notice will populate in the list. The Date Sent column will update with the date you sent the notice. You can view the notice to see the content, but you will not be able to edit or delete sent notices. You are only able to edit/delete notices that have not been sent out.

Setup Committee List

Committee Setup lists the current committees for the review board. From the committee setup list page you can add new committees and edit/delete existing committees.

Opening the Committee List page will display a list of current committees in your review board. This is a list of the committees only. Access to committees is defined in a user’s account. Once a committee is set up, you will be able to associate users to the committee through user access in the system.

If your review board is set up for Committee Submissions (property rb.use_submission_by_committee set to “Yes”), the system will be setup to route submissions to individual committees and not the review board as a whole. The committees in this list are the committees that will receive the submissions. When your review board is set up for Committee Submissions, members of one committee will not be able to access submissions that were not sent to their committee.

Most systems are not setup for Committee Submissions; rather, all submissions arrive in the review board submission queue. When the submission is processed it will be placed on the appropriate committee’s meeting date. Each committee will have its own set of meeting dates.

Committees can be added, removed, and renamed from this area.

Click the Add a Committee button, enter the committee name in the Description, then click the Save Committee button.

To delete a committee, select the checkbox next to the committee name, and then click on the Delete Selected Committee(s) button.

To rename a committee, click on the Edit icon next to the committee name.

A new page will open. You can modify the name by changing the Description. Click the Save Committee button to save your changes.

The changes will display in the list of committees.

If your account has been assigned to more than one committee within the review board, you will be able to flip between the committees by selecting the appropriate committee from the review board assistant menu.

Each committee will have its own unique information. Switching committees will show you details for that committee when you click on certain screens in the review board assistant menu: Meeting Agenda, Meeting Minutes, and Meeting Manager will all display information only for the committee you are currently in.

If your system is setup for Committee Submissions, the submissions queue will only contain forms sent to the committee you are currently in.

Setup Review Board Roles

Your review board will be preset with review board roles that you can associate to users within your review board. These roles are listed in Setup Review Board Roles. From here you can rename certain roles or add new roles as needed. Each role you define in this list can then be configured in the Setup Role Access area to have access to only certain screens within the review board. This is covered in Setup Role Access, below this section.

Opening the page will list all the current roles for your review board. These are iRIS predefined review board roles and you can rename these as needed (if you want to call a role something else). However, you will not be able to delete the iRIS predefined review board roles. These predefined iRIS roles will say “Yes” in the Reserved column and you will not see a Delete icon next to the role name.

To change an existing role name or change the order in which it is displayed, click the Edit icon.

A new page will open. From here you can change the Order Number and Role Name. When you are finished making changes, click the Save button. To return to the list of roles without making changes, click on the Back to List button.

To add a new role, click on the Add a New Board Role button.

Enter the Order Number and Role Name.

In Use - When adding a brand new role to the review board, you will also be able to specify if the role is in use. This tells the system whether to activate the role or not. If In Use is set to “Yes,” then you will be able to assign a user this role. If In Use is set to “No,” then you won’t be able to assign a user this role. The reason for this function is to discourage deleting a role that has been used and is assigned to users. Rather than deleting the role, you can set In Use to “No,” which will preserve the history of this role and will remove the role from future use. If a role that has been used in the past is deleted, links and historical records associated to the role may not display properly.

Allow Alternate for Meetings – Set this flag to “Yes” to allow members assigned this role to be assigned an alternate at a meeting. Any user given the Alternate Member role or a role with this flag set to “Yes” will be included in the Alternate For list within Grant User Access & Define Roles as shown in the screenshot below.

When you are finished adding the details for the new role, click on the Save button.

If there are more than ten roles in the list, you will need to use the page navigation to see the role you added. At the top right of the table is a list 1-10 with a green arrow. Click on the green arrow to view the next page.

Any role added outside of the existing roles will read “No” in the Reserved column.

Setup Role Access

Setup Role Access gives you the ability to allow user(s), by role on the review board, read/write privileges within certain screens.

This page will list available screens on the left side of the matrix. The top of the page displays a list of current review board roles. Within each role are checkboxes for Read and Write. Each of these cells represents access for that user to the screen name on the left.

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

If “Read” is selected, but “Write” is not selected, that means the user has been granted read-only access 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 first giving them 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 review board will have access to that screen. This is recommended for use if you do not want to see a particular screen within your review board.

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.

If you had set up a role in Setup Review Board Roles, you would need to setup that role’s access in the Role Matrix. Any new role added to Review Board Roles 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 would need to review the role within the matrix and setup the appropriate Read and Write access for that role.

Be sure to click the Save Changes button after making any changes to this screen.

Note: This page may take a few moments to save. After clicking on the Save Changes button it is recommended that you wait for the page to finish loading before navigating away.

Setup Electronic Document Stamp

The Document Stamp Setup page is used to setup the document stamp details. The document stamp is applied to documents that have been approved by the review board.

The Document Stamp Setup page can be used to set up different document stamps.

The document stamp is used on Study Documents that require approval of the IACUC. Required fields are marked with red asterisks (*).

To add a new stamp, click the Add a New Stamp button.

The following screen will display:

Title – Indicate the Title of the stamp by filling out the Title text box.

Type – Choose the type of stamp. Types available are General Purpose (used for all documents, consent and other study document alike), Informed Consent (used only on consent forms), and Study Document (used only for other study documents). *Consent form is not an option for IACUC modules.

Category – When the Study Document Type is selected, the user will need to select a category.

Comments – Add any necessary comments in the Comments text area.

Show Stamp On –Specify if the stamp appears on all pages or the last page only

Use Placeable Stamp – Checking this box will allow you to place the stamp on the document using exact coordinates.

Stamp Position On Page – When the exact coordinates are not known, checking the desired position can be done in this field.

Font Type – You can change the font type of the words appearing in the stamp. The preview at the top right will adjust to the selected font.

Font Size – You can change the font size of the words appearing in the stamp. The preview at the top right will adjust to the selected font size.

Font Color – You can change the font color of the words appearing in the stamp. The preview at the top right will adjust to the selected font color.

Opacity – You can change the opacity of the stamp. The preview at the top right will adjust to the selected opacity.

Scale Image to Fit – Checking this box is highly recommended when an image is included in the stamp. This checkbox will scale any uploaded images to fit the small size of the stamp.

Upload – Click the Upload button to browse your computer for the image that will be used with the stamp.

After clicking the Upload button, a dialog box displays. If the location of the image is known, type it into the Document Location text box. Or, click the Browse button to search for the image. When finished locating the image, click the Save selected file button to upload the image, or click the Cancel button to cancel out of uploading an image. 

Preview Stamp Layout – When all the options are set as desired, you can click this button and a new window will pop up containing a preview of how the stamp will look in a document. It is highly recommended that you do this because some fonts might be too big and words might get cut off.

When you are finished setting the details of the document stamp and uploading an image, click the Save Stamp Details button to save all changes made.

Additionally, you can edit or delete existing stamps. To delete existing stamps, check the boxes next to the desired stamps. There is an option to select or deselect all by clicking the icon. Click the Delete Stamp(s) button.

Setup Study Numbering

This feature is used to set up automated IACUC numbers. From this area you can set up the configuration for that auto-numbering.

To use this feature, select “Yes” to Use Sequence for IACUC Number. Even if the numbering is configured, the system will not use the numbering without this option being set to “Yes.”

To set up variables in automated IACUC numbers, click the checkbox in the Use in Number column to indicate use in the number. In this case, Constant Prefix, Calendar Year, and System Generated Number are being used to create the IACUC number. These are listed in the second column, Description of Number Part. The next column, Number Part Information, is where data values are given to the auto generated number. The last column specifies which separator to use between the chosen number parts.

The Constant Prefix will begin all IACUC numbers with the prefix as specified in Number Part Information. It will be followed by a separator (-), as indicated in the Separator column. A School Code can also be used. This code is added when setting up the department list in System Administration (See System Administration manual). The school code will be pulled from the primary department listed on the study. The Calendar Year will use the year, displaying either all four digits, or only the last two, depending on which is selected. The last row indicates that a System Generated Number will be used. The first text box is used to specify where the number should begin. In this example, the auto-generated number will start at 1 and then increase each time a new IACUC number is created. The Number of Digits specified indicates how many digits will be used. In this case, the auto generated number will start at GH-14-001, and increase one digit each time it is assigned to a study, e.g. GH-14-002, GH-14-003, GH-14-004, etc.

If you make any changes to this screen, be sure to click the Save Numbering button.

Setup Agenda Categories

You can create agenda categories to use in the Finalized Agenda and Agenda Revision templates. These categories will be created using assigned unique merge codes that identify each category. You will be able to associate submission types to each category. This allows you to create agendas for each type in either the Finalized Agenda Document Template section or the Agenda Revision Document Template section (see screenshot below).

This is where you define the categories that will be included in the agendas (finalized and revision) and in the meeting minutes templates. The categories are for the different types of submission that will be made to the review board and will come up on an agenda or meeting. After you create a category, you can go into Setup Finalized Agenda Document Template, Setup Agenda Revision Document Template or Setup Meeting Minutes Template to create the template for this category. For more information on creating these templates refer to that section of the manual.  

This section is only available if rb.use_meeting is set to “Yes” (See Board Configuration Options).

The name of the group will be displayed under Group Name. The code that will be used to reference this group will be displayed under Merge Code. The order in which the sections will appear in the Setup Finalized Agenda Document Template, Setup Agenda Revision Document Template, and Setup Meeting Minutes Template sections will be displayed under Group Display Order. Two groups may have the same group number – the most recently added will be listed after the older group.

Before creating a new group, you must add the appropriate filters to the agenda. To do so, select the Add Agenda Filter button.

A new page will be displayed with a list of filter types (if already defined). To delete one or more filters, select the checkbox next to the filter(s) to be deleted. Select the Delete Filter(s) button. A confirmation dialog will appear; select OK button to complete the deletion or select the Cancel button to cancel the deletion. To edit a filter, click the Edit icon next to the appropriate filter. Make the necessary changes. When you are finished editing the filter, click the Save All Changes button.

This column displaying the type of the filter will be displayed under Filter Type. The name of the filter will be displayed under Filter Name. To add a new filter, select the Add Filter button.

A new page will be displayed, prompting you to enter the Filter Type and Filter Name (both are required fields). The Filter Types that can be added are Designated Reviewer, Expedited, Exempt, Processed Administratively, Previously Reviewed, Conflict of Interest, Board Chair COI filter, and User Defined. The Filter Name field will be auto-populated when a type is selected unless the Filter User Defined is selected. In that case, the name will have to be entered manually and rules for this filter will have to be defined (see below).

The checkbox will be used to delete a clause. If there is more than one clause to a filter, they can be ordered in a sequence of which Order they will be run by the system. Order number 1 will run first, then 2 and so on. The first dropdown menu under the What to Filter column contains the items that may be selected for the system to check.

1. Applic. Form all columns – This will allow you to select the desired application if you have multiple applications in your system, and will list all of the data values for the selected application in the Data Value column.

2. Submission Form all columns – This will list all of the submission forms in a drop down list. When a form is selected, all the data values in that form will populate in the Data Value column.

The Data Value column will populate depending on whether you select application form or submission form from the dropdown list in the What to Filter column. The What Form? dropdown menu allows you to select the specific form that you would like to base your filter off of. The What Form Column? menu allows you to select the data value from the form, identified by its database column name. Once you have selected a form and a column, a space will appear to enter your needed value to create the filter. In the example below, the data value is a Yes/No selection. In other cases, you will have a text box in which you can type your needed value (see the above screenshot for an example).

The second row in the What to Filter column is the comparator for the filtering item selected. You can select EQUAL to indicate that the response in the form for the chosen data value should equal the value you select, or NOT EQUAL to indicate that the answer given in the form should not equal the value you select.

The “Join by, if any” dropdown menu is used when you wish to define more than one clause. The AND value signifies that all clauses have to be true for the filter to be true. The OR value signifies that only one clause has to be true for the filter to be true. Select –none- when there is only one clause in the filter.

A new clause can be created by selecting Add a new Clause button. To delete a clause, select the box(es) next to the appropriate clause(s) and select the Delete Clause(s) button.

After all values for the filter have been defined, click the Save All Changes button. This will return you to the filter list screen with the new filter listed. Add new filters as needed, or select the Back button to go back to the agenda group list.

To create a new group, click the Add Group button.

The 3 required fields are:

1. Group Name –This is what will be displayed in the Setup Finalized Agenda Document Template, Setup Agenda Revision Document Template and Setup Meeting Minutes Template sections, and within the Agenda page.
2. Group Order - This determines in which place in the list of groups this will appear. It must be a positive integer.
3. Group Merge Code - This is the code that the system will use to refer to this group when inserting it into the master template for the Setup Finalized Agenda Document Template, Setup Agenda Revision Document Template, and Setup Meeting Minutes Template sections.

There is a table underneath these fields. This is used to add submission types to this group. This means that any type of submission that is categorized with this group will pull into the section that uses the Merge Code created for this group. This will not display the entire form that is submitted, but only the information (e.g., PI, Study Title) that is specified in the Setup Finalized Agenda Document Template, Setup Agenda Revision Document Template, and Setup Meeting Minutes Template sections.

To add a submission type, click the Add button found above the right side of the table. A pop-up will open. This lists all of the available submission forms defined in your system. You may add one or more by checking the box(es) next to the form(s) that you would like to select. Click the Select button to add these forms to the group. Click the Cancel button to close the pop up without adding any forms.

The added form(s) will appear in the table with the filters created previously listed under it. Each filter will have a drop down menu with three selectable options: “No Match Required,” “Include if this Type is found,” and “Not Included if this Type is found.”

No Match Required – Select this option to indicate that you want this submission status filter to be included in this group.

Not Included if this Type is found – Select this option to indicate you do not want any submissions with this status filter to be included with this group.

Include if this Type is found – Select this option to indicate that you want submission types with this status to be included in the group, and also exclude all undefined status filters from the group. It will also exclude the status filters that are defined as No Match Required.

When you are finished adding the form definitions for the group, click the Save All Changes button to add this group to the agenda categories list. To remove a form from the group, check the box next to the form to be deleted and click Remove.

After returning to the main Agenda Category screen, if you wish to delete one or more groups, check the boxes next to the group(s) to be deleted. There is an option to select or deselect all by clicking the icon. Click the Delete Group(s) button. A confirmation dialog box appears; click the OK button to complete the deletion. To cancel, click the Cancel button.

To edit a group, click the icon next to the appropriate group. Make the necessary changes. When you are finished editing the group, click the Save All Changes button.

This list will be viewable on the Meeting Agenda screen.

Setup Finalized Agenda Document Template

You can create a master template for your Meeting Agenda document. This template will store your meeting agenda outline. You can use merge codes to pull in submission information as well as other key study elements into the agenda.  (See the IACUC Assistant – Meetings manual for instructions on how to generate the agenda for a specific meeting).

The Finalized Agenda Templates page lists the Agenda Template Master, which is used to describe the general layout of the agenda document, and the different sections that can be added to the master template. You can setup the template for these sections, which will merge data from each submission into the Master Agenda Template.

You will first define the content of the Agenda Template Master. To do so, click on the Setup Agenda Template button.

A new page will open, containing an embedded Word editor. If the template master has already been created, it will be displayed similar to the example above. If the master was not created, this is where it can be created using the features of the text editor and inserting merge codes. To insert a merge code, click the Insert Merge Code button. A window will pop up listing the available merge codes. Select the merge code to insert, and then click the OK button.

A merge code is a programmed label that will pull information into the document when the document is generated. In the example above, when the Agenda is generated for a specific meeting date, the merge code for the meeting date will populate with the date of the meeting.

You can set up your Agenda template in any way, using the tools available in Word and with the use of the merge codes.

You will want to pull your agenda sections into the Agenda Master Template, which are found towards the bottom of the list of merge codes.

Merge codes are used to tell the Agenda Template Master to pull in specific information about the submissions being reviewed at a particular meeting.

These merge codes are setup in the Agenda Master Template and will pull in information from the sections set up in the Section Information.

When you are finished editing or creating the template master, click the Save Changes button (top of the screen).

When a Meeting Agenda is generated for the review board, the general information listed in the Agenda Template Master will display. Then, the agenda will list each of the submissions assigned to the meeting based on the section merge codes set up in the Agenda Template Master.

You will set up what the Agenda Template Master should display for each type of submission in the appropriate Section Information. To edit a submission type template, click on the Setup Section Information button.

Edit or create this section as explained in creating/editing the Agenda Template Master, except this information will be specific to the type of submission, not the general Meeting Agenda information.

When you generate a Meeting Agenda for a specific meeting date, the system will generate one document using the Agenda Template Master and the Agenda Template subsections.

Validate MergeCode Formatting

Validate MergeCode Formatting is a functionality that allows you to test whether the merge codes in your template contain invalid RTF content that will prevent them from populating correctly in your documents. For example, if the text in part of a merge code, but not the entire merge code, is bolded, this is the type of error that Validate Merge Code Formatting will correct.

When you click Validate MergeCode Formatting, one of three things will occur. If all the merge code formatting in your template is valid, you will see the following message:

If any of your merge codes contain invalid content, as seen below, you will get a popup message displaying the merge codes that the system could correct for you.

In the example given, you can see that part of one merge code is bolded and the other is partially italicized. When you click Validate MergeCode Formatting, you will see the following popup:

When you look at the document again, the merge codes are corrected. If you need to, you can click the Undo Changes button to revert to the previous version of the merge codes.

If there is an incorrect merge code that cannot be validated, the system will return an error message. For example, if ”[%” or “%]” is entered in the template with no other associated merge code content, you will receive the following error:

You can go in and remove any incorrect merge code data as described above or follow the instructions in the error message to manually clear merge code formatting.

When you have finished editing the template, click Save Change, or click Back to return to the main setup screen without changes. On the Consent Template Master Setup screen, click Save Template to finish completing your template and return to the main list of templates.

Setup Agenda Revision Document Template

This has the same concept as the Finalized Agenda Document Template page. It has an Agenda Revision Master Template and subsections to set up details for different submissions. The Revision Agenda Template is used to generate an addendum in the case that a new submission is placed on the agenda after the main Agenda has been published for the meeting date.

The Agenda Revision Templates page lists the Revision Master Template (describes the general layout of the agenda’s document) and the different sections that can be added to the master template. You can set up the template for these sections individually, which will merge data from each submission into the Master Agenda RevisionTemplate.

You will first define the content of the Agenda Revision Template Master. Click on the Setup Revision Template button.

A new page will open, containing an embedded Word editor. If the template master has already been created, it will be displayed similar to the example above. If the master was not created, this is where it can be created by using the features of the text editor and inserting merge codes. To insert a merge code, click the Insert Merge Code button. A window will pop up listing the available merge codes. Select the merge code to insert, and then click the OK button.

A merge code is a programmed label that will pull information into the document when the document is generated. When the Agenda is generated for a specific meeting date, the merge code for the meeting date will populate with the date of the meeting.

You will want to pull your agenda sections into the Agenda Revision Template Master, which are found at the bottom of the list of merge codes.

Merge codes are used to tell the Agenda Revision Template Master to pull in specific information about the submissions being reviewed at a particular meeting.

Merge codes are entered in the Agenda Revision Master Template, and will pull in information from the sections set up in the Section Information.

When you are finished editing or creating the template master, click the Save Changes button.

When a Meeting Agenda Revision is generated for the review board, the general information from the master template will display. Then, the agenda will list each of the submissions assigned to the meeting based on the section merge codes set up in the Agenda Revision Template Master.

You will setup what the Agenda Template Master should display for each Submission in the appropriate Section Information. To edit a submission type template, click on the Setup Section Information button.

Edit or create this section as explained in creating/editing the Revision Agenda Template Master, except this information will be specific to the submission, not the general Meeting Agenda information.

When you generate a Meeting Agenda Revision on a specific meeting date, the system will generate one document using the Revision Template Master and Agenda Template subsections.

Setup Expedite Report Template

Generate a report to attach to a meeting date that will summarize Expedited Reports. This feature is only available if the review board property rb.use_expedited_report is set to “Yes” within the Meeting Settings group.

The Expedite Report Template works similar to the Meeting Agenda and Minutes Templates. You can define text and merge codes within an embedded Word document. The Expedited Report Template does not contain sections like the Agenda and Minutes templates. The Expedited Report Template will contain one section to set up, as shown in the screenshot below. Click the Setup Template button.

This will open the embedded Word document. Click on Insert Merge Codes to add the Expedited Group merge code. Your Expedited submission information must be set up in the Expedited section when you are setting up the Finalized Agenda. Click on Save Changes when you are done.

To generate an Expedited Report, you must go to a finalized meeting agenda within Review Board Assistant > Meeting Manager. Start by clicking Generate an Expedite Report under the Expedite Report group. The system will generate a document based on any Expedited submission placed on this particular meeting date. (Note: The system will identify Expedited submissions based on the rules set up when creating agenda categories.)You can edit the document before publishing by checking out the document to your desktop (Check-Out the Expedite Report For Editing In Word) or you can make your changes within the browser (Edit the Expedite Report Within The Browser). When you are finished, click Publish the Expedite Report to convert the Word document to a PDF document.

Once you publish the Expedited Report, a PDF file will populate on the Meeting Agenda in the Expedite Reports section. This table will also contain the number of Expedited submissions included in the report.

Setup Meeting Minutes Template

You can create a master template for your Meeting Minutes document. This template will store your meeting minutes outline. With the use of merge codes you can pull in specific information regarding the meeting when you generate the minutes for that meeting (see documentation on the Meeting Manager for instructions on how to generate the minutes for a specific meeting).

The Minute Templates page lists the Minutes Template Master and the different sections that can be added to the master template. You can set up the template for these sections, which will merge data from each Submission into the Master Minutes Template.

You will first define the content of the Minutes Template Master. Click on the Setup Minutes Template button.

A new page will open, containing an embedded Word editor.  If the template master has already been created, it will be displayed like the example in the above screenshot. If the master was not created, this is where it can be created by using the features of the text editor and inserting merge codes. To insert a merge code, click the Insert Merge Code button. A window will pop up listing the available merge codes. Highlight the merge code to insert, and then click the OK button.

A merge code is a programmed label that will pull information into the document when the document is generated. In the example above, when the Minutes document is generated for a specific meeting date, the merge code for the meeting date will populate with the date of the meeting.

You can set up your Minutes template using the tools available in Word and the available merge codes.

You will want to pull your agenda sections into the Minutes Master Template, which are found at the bottom of the list of merge codes.

Merge codes are used to tell the Minutes Template Master to pull in specific information about the submissions being reviewed at a particular meeting.

The section merge codes entered into the Minutes Master Template will pull in information from the sections set up in the Section Information.

When finished editing or creating the template master, click the Save Changes button.

When Meeting Minutes are generated for the review board, the general information will display in the Minutes Template Master. Then, the document will list each of the submissions assigned to the meeting based on the section merge codes set up in the Minutes Template Master.

You will set up what the Minutes Template Master should display for each submission in the appropriate Section Information. To edit a submission type template, click on the Setup Section Information button.

Edit or create this section as explained in creating/editing the Minutes Template Master, except this information will be specific to the submission, not the general meeting information.

When you generate Meeting Minutes on a specific meeting date, the system will generate one document using the Minutes Template Master as well as the subsections.

Setup Outcome Letter Groups

The Outcome Letter Groups are defined and listed in this screen.  The groups created here will be listed in the Letter Types dropdown list on the Setup Outcome Letter Templates screen, as shown below.

The list of Outcome Letter Groups will be similar to this screen below.

To delete existing groups, check the boxes next to the desired group(s) and click the Delete Group(s) button. It is possible to select or deselect all checkboxes by clicking on the icon at the top of the column of checkboxes. To edit a group, click the Edit icon.

To add a new group, click the Add Group button.

Type in the Group Name, as this is a required field. To associate this particular outcome letter type to a submission type, click the Add button.  The following screen will display:

Check the box next to the desired submission form(s) types to include in this category, and then click the Select button.

The selected form(s) will be added to the Outcome Letter Group. Listed in columns next to the submission form name will be several columns listing different review processes, depending on your system settings. This allows you to specify which review process any letter associated to this group should display for. If a letter group applies to a Full Board review, no selection is needed. The form being listed in the group will cause the letter to display. Select the checkbox in the columns that are applicable, then click the Save All Changes button.

To remove unwanted forms, check the box next to the desired form in the table and click the Remove button.

In the above screenshot, the Group Name is called “Incidents.” In the Setup Outcome Letter Templates screen, outcome letter templates can be created and associated to this letter type by selecting the “Outcome-Incidents Type,” from the dropdown list. Any template that is saved in the Outcome Letter Templates list that is of the type “Incidents” will then appear in the Notification Letter dropdown list when an incident submission (using the submission form listed above) has been assigned to a Full Board review.  

Setup Outcome Letter Templates

You can setup your review board’s Outcome Letters here. Letter templates are created using merge codes that will pull information specific to the submission when the letter is generated.

When you open the page, any letter already defined for the review board will list on the page, displaying the Title, Letter Type, Last Modified By, and Date Modified information. You can edit an existing letter by clicking on the Edit icon or you can add a brand-new letter by clicking on the Add a New Template button.

If the number of letter templates exceeds ten results, a small green arrow will display on the top right of the letter templates table. Click this arrow to move to the next page of letter templates.

When you add a new letter template, a page will open containing an embedded Word editor. If you had chosen an existing template, the Word editor would contain the content of the letter template. Enter the Title of the template and select a Letter Type from the drop down list. Any of the Outcome Letter Groups created will populate in this list, along with two other standard letter types: Submission and Outcome – General.

Selecting the Letter Type from the dropdown list will cause the letter template to be listed among the templates available in the Outcome tab in the submission processing screens, depending on the submission form and the review process selected.

The other letter types, Outcome – General and any of the custom Outcome Letter Groups created will cause a letter associated to its group to display within the Outcome tab. Filters associated to the custom Outcome Letter Groups will cause a letter to appear or not appear in the dropdown list, but a letter associated to the Outcome – General Group will always be available. For example, a letter associated to the group called “Outcome – Full Renewal Approval” will only be available when a Full Renewal Submission type is being completed, because the filter is associated to the Full Renewal Submission type. If you are processing any other submission type, this letter will not be available.

Add content to the template by inserting merge codes (click the Insert Merge Code button) and using features of the embedded Word editor.

When finished creating the template, click the Save the Letter Template button to save.

Setup Canned Motion

You can setup a list of canned motion text that you can use to pull into a motion for a submission. You can have any number of canned motions in this list.

When you open the page, a list of any canned motions will display. If canned motions have not yet been added, this page will not list any records. You can click the Add a New Motion to add a new canned motion to the list.

When you add a new canned motion, you will need to provide the Name of the motion and the Item Number (order in which the canned motion is displayed). To add the content of the canned motion, click on the link ‘Click here to edit/view the motion text’.

This will open a new page containing an embedded rich text editor. You can copy and paste or type in your canned motion text. Click the OK button when you are ready to add the text to your motion.

After adding the Name, Item Number and text for the canned motion, click the Save Changes button and the record will be added to the list of canned motions.

Canned motions can be edited by clicking on the Edit icon next to the name of the motion. This will open a new page allowing you to modify the Name, Item Number, and text for the canned motion.

You can delete a canned motion by selecting the checkbox next to the appropriate canned motion and clicking on the Delete Selected Motion(s) button.

Any canned motion added will display in the Precanned Motion text dropdown list when you are adding a motion to a submission on the Vote tab of the Submission processing screens.

Setup Template Language

When you generate Minutes, Agendas, and Outcome Letters you have the ability to merge in template language. This is in case you have specific language you want to pull into multiple different documents. You can set up a list of template language under Setup Template Language and pull in any template language to your Minutes or Agenda or Outcome Letter as needed.

When you open the page, a list of any template language defined will display. If templates have not yet been added, this page will not list any records.

You can click the Add a New Approved Text button to add new template language to the list.

When you add a new template language, you will need to provide the Name of the template language and the Code (the merge code iRIS uses to insert language into a document). The Code must be alpha-numeric and cannot contain spaces or special characters. To add the content of the template language, click on the link ‘Click here to add the language text’.

This will open a new page containing an embedded Word editor. You can copy and paste or type in your canned motion text. Click the Save Changes button when you are ready to add the text to your template language.

After adding the Name, Code, and text for the template language, click the Save Approved Text button and the record will be added to the list of template languages.

Template Language can be inserted into Outcome Letters, Meeting Minutes, and Meeting Agendas. Above the embedded Word editor of the generated letter, agenda, or minutes you will see an Insert Template Language button.

First, position your mouse cursor in the document where you would like to insert the language.

Clicking the Insert Template Language button will open a small popup window that will link to your list of template languages. Click on the language you wish to insert into the document.

The popup will refresh, displaying the text of the template language. You can highlight the text of the language and copy and paste it into your document, or you can click the Insert Template Language button. Doing this will close the popup window and insert your language into the document.

Setup Correspondence Templates

You can set up templates that you can pull into correspondence generated for a submission. You can have any number of templates and pull any template into correspondence within the submission processing screens.

When you open the page, a list of any correspondence templates defined will display. If templates have not yet been added, this page will not list any records. You can click Add Template to add a new template to the list.

When you add a new template language, you will need to provide the Title of the template language. Beneath the Title field is an embedded rich text editor where you can copy and paste or type in the content of your correspondence template. You can also insert merge codes that will pull in specific information when the correspondence template is added to a specific submission. Click on the Insert Merge Code button for a list of available merge codes. To insert a merge code, position your mouse cursor in the document where you would like the code to be inserted, click the Insert Merge Code button, and click the code you want to insert.

When you are finished adding content to the correspondence template, click the Save Template button.

Correspondence Templates are used when you create a correspondence record for a submission within the submission processing screens. Above the embedded rich text editor, a dropdown will contain the available templates.

Setup Review Cycle

You can create review cycles that can be used to calculate the expiration date on the Outcome tab of the submission processing screens. If you have an IACUC Submission Approval Date, the IACUC Expiration date can be calculated based on your pre-defined review cycles. Please note that the review cycle calculates based on ‘x’ number of months.  

When you open the page, a list of any review cycles defined will display. If review cycles have not yet been added, this page will not list any records.

You can click Add a Review Cycle to add a new record to the list.

This will open a new page containing information related to the review cycle.

Enter the Name of the Review Cycle and the number of months in the Review Cycle Number in Months field. Click the Save Review Cycle button and the record will be added to the list of review cycles.

The Review Cycle is available in the Outcome tab within the Submission Processing screens. Once the approval information is entered, you may select a Review Cycle from the drop down list, as shown in the screenshot below.

Based on the Submission Approval date and the number of months associated to the Review Cycle selected, the IACUC Expiration will auto-populate.

Available to Purge

This area of Review Board Administration will populate with study records when they are ready to be archived in the database.

Studies can be archived and hidden from the user interface when certain conditions on the study are present. To archive a study, click the checkbox next to the record, and then click the Purge Selected Studies button. A popup box will open asking you to confirm the purge. If you confirm, the study will be removed from the list of studies available for purge. The study will also be removed from all study screens (Find a Study, My Studies, etc.) and will no longer be visible to any user. If you choose not to continue with the purge, the study will remain in the list of studies available to archive.

In order for a study to be available to purge, the following conditions must be in place for the study:

1. The study must belong to the IACUC board.
2. The study must be in a Study status that has the flag “Available to Archive” set.
3. The study must have a Termination Date set in the Study Profile that is 3 years prior to the date the study was set to the Study Status with the “Available to Archive” flag.

Once a study is purged, it will no longer be searchable in iRIS. The study will be kept in the database but will be flagged as deleted/archived.

Review Board Notification Setup

Review Board Notifications can be set up to send to study personnel as well as to members of the board. These notifications include such notices as Reviewer Assignments and Letter Signoff notifications.

Notifications can all be set up in the same way, by entering the content of the email and using merge codes to pull in specific information. Start by clicking the button to add a notification.

All notifications will require a Title. This will be the subject line of the email.

Certain notifications will require a number of days. This is typically how many days prior to a certain date you want the notification to send.

You will also be able to specify whether to send the email notification by selecting “Yes” or “No” in the Send E-Mail Notification column. If “Yes” is set, the notification will send to the recipient. If “No” is set, the notification will not send. You would set a notification to “No” if you do not want the notification to be sent by email but you do not want to delete it from the system.

Some notifications will allow you to select additional recipients if there is a Send To column. Click the Add button and you will be able to search the database for a user to add as a recipient. You can have any number of additional recipients for the notification. To remove an additional recipient, click the checkbox next to the name then click the Delete button.

Other Send To options specify the Principal Investigator and Study Contact. These notification types default to both being selected, however, if you need to limit the notification from sending to either study role, uncheck the recipient before saving the notification page.

Within the E-Mail Content portion of the notification you can enter the body of the email. You can type in or copy and paste text and use the system merge codes to pull in specific information when the notification is generated. Click the Insert Merge Code button and a small popup window will open, allowing you to select the merge code you wish to use.

Submission Notification Setup

The Submission Notifications will generate and send to the study when the review board returns a submission for pre-review or post-review changes. You can also define reminder notifications when the study does not respond within a certain amount of time to these requested changes.

Submission Types

These two notifications will generate and send when the review board requests changes. The Submission Correction notification will generate and send when the review board indicates there are pre-review changes. The Review Response notification will generate and send when the review board adds stipulations and sets the Submission Outcome to an outcome that will return to the study.

Response Pending Notification

The Response Pending notification will send a certain amount of days after a submission has been returned to the study and works with the Review Response Request. This notification will send ‘x’ amount of days after the Review Response Request has been sent if the study has not responded.

Continuing Review Notification Setup

The Continuing Review Notification will alert selected users of an upcoming Continuing Review. An e-mail will be sent out as specified in the screenshot below. There are currently three notifications set up: one to be sent 90 days prior to the expiration date, one 60 days prior, and one 30 days prior. These can be modified, deleted, and new notifications can be added.

The notifications will be sent out in the amount of days specified before the Review Board Expiration Date set for the study by the IACUC in the Outcome Tab.

Expiring Study Notification

The Expiring Study Notification is sent to selected iRIS users once a study has expired.

Renewal Notification

This notification will generate based on your IACUC study expiration date, and it will be sent out when your entire study is about to expire.

Board Members Notification Setup

IACUC study notifications can be sent to the entire board committee, other than assigned reviewers.

To setup this functionality, System Administrators can navigate to: IACUC Assistant > Review Board Administration > System Setup. There will be a setup configuration called: Board Members Notification Setup. Clicking on the Board Members Notification Setup, then clicking “Edit”, and selecting “Yes” to the field “Send E-mail Notification”, gives board members the ability to send notifications to just the board members added to the submission.

When reviewing the submission, board members can navigate to the “Pre-review Screening” tab, select “Assign to Review Committee Agenda”, and then select a “Committee Name”. After this a “Send Full Board Review Notification” button will appear. After selecting this button, the notification will be sent to all full board members. A full board member is a board member who appears under “User Management > Grant User Access > Define Roles, and whom also has “Board Member” as a role.

Reviewers Notification Setup

Reviewers Notifications are programmed to send to the assigned reviewers of a submission. There is also a notification you can set up to let the assigned analyst of a submission know when reviewers have completed their review.

Reviewers Complete Notification

This notification will trigger and send to the assigned analyst when reviewers have completed their reviews for a submission.

Reviewer Assignment Notifications

These notifications will generate and send to an assigned reviewer based on the review process of the submission. You can also set up a notification to send to the reviewer if they have been removed from the review.

Agenda Reviewer Assignment Notification

This notification will send to a full board reviewer. Note that you must also have Enable Reviewer Notifications set to “Yes” for the Meeting Date in Meeting Manager before any full board review notifications will send.

Expedited Reviewer Assignment Notification

This notification will send to an expedited reviewer as soon as you assign them to review the Submission.

Designated Reviewer Assignment Notification

This notification will send to a Designated Reviewer as soon as you assign them to review the Submission that has been assigned the review process “Designated Reviewer.”

Designated Review Member Assignment Notification

This notification will send to a board member who has been assigned to a Designated Member Review for a submission.

Exempt Reviewer Assignment Notification

This notification will send to an exempt reviewer as soon as you assign them to review the submission.

Process Administrative Reviewer Assignment Notification

This notification will send to an administrative reviewer as soon as you assign them to review the Submission.

Reviewer Unassignment Notification

This notification will send if you delete a reviewer assignment task.

Reviewer Assignment Reminder

You can set up a notification that will send out every time a specified number of days after the review assignment has passed to remind the reviewer of their task.

Internal Routing Notification

These notifications will send to a user assigned an Internal Routing task and also to the Assigned Analyst when an Internal Routing task is completed.

Internal Routing Assignment Notification

This notification sends to a user assigned an Internal Routing task.

Internal Routing Complete Notification

This notification will send to the assigned analyst when all assigned users have completed their Internal Routing tasks for a submission.

Pre Review Assignment Notification

The Pre-Review Assignment Notifications will send an e-mail to the study when a submission has been assigned a certain review process. Each notification listed on this page matches a process in the Pre-Review Screening tab of the Submission Processing screens.

Pre Review Agenda Assignment Notifications

The Pre Review Agenda Assignment Notification is sent when a submission has been placed on the agenda for full board review.

Pre Review Expedited, Exempt, and Administrative Notifications

The remaining notifications are sent when a submission has been processed a certain way (Expedited, Exempt, Administratively Processed) by the review board. Depending on your system settings, you may or may not have all these notification types listed on this page.

Pre Review Denied Notification

This page allows E-mail notifications to be sent out as a reminder when a Pre-Review has been denied. You can enter a number of days after which the reminder will be sent.

Meeting Agenda and Minute Notification

The Meeting Agenda and Minutes notifications send out to board members when you generate, publish, and then indicate to the system to send out the agenda or minutes for a specific meeting date in the Meeting Manager. These include the PDF published versions of the appropriate document as an attachment, and will send to all board members or to members present at a specific meeting, depending on what notification is sending out.

Final Meeting Agenda Notification

This notification will generate when you send the published Meeting Agenda for a specific meeting date in the Meeting Manager. It will attach the PDF Meeting Agenda and send to all committee board members.

Revised Meeting Agenda Notification

This notification will generate when you send a published Revised Meeting Agenda for a specific meeting date in the Meeting Manager. It will attach the PDF Meeting Agenda Revision and send to all committee board members.

Final Meeting Minute Notification

This notification will generate when you send the published Meeting Minutes for a specific meeting date in the Meeting Manager. It will attach the PDF Meeting Minutes and send to all board members present at the meeting.

Draft Meeting Minute Notification

This notification will generate when you send a copy of the Draft Meeting Minutes for a specific meeting date in the Meeting Manager. It will attach the PDF Draft Meeting Minutes and send to all board members present at the meeting.

Meeting Attendance Notification

You can set up notifications that will send to board members a certain amount of days prior to a meeting date, asking them to log in to the system and set their meeting availability. You can also set up a notification that will send to the board Coordinators if any member changes their availability within a certain amount of time prior to a meeting date.

Meeting Attendance Notifications

If you would like to send notifications to board members to alert them to set their availability for upcoming meetings, you can set up reminders here. These notifications will send a certain amount of days prior to a meeting date to let the member know they need to set their availability. You can have any number of notifications set up.

Member Attendance Change Notification

This notification will send to the board Coordinators a certain amount of time prior to the meeting date if any member has changed their availability.

Designated Review to be placed on the Agenda Notification

This notification will send to the submission’s assigned analyst when the assigned Designated Reviewer indicates that a submission is recommended for full board review.

Outcome Letter Notification

Notifications related to Outcome Letters are set up here. These notifications send to Outcome Letter recipients, to users assigned to sign an Outcome Letter, and to alert analysts that signoffs on letters have been completed.

Outcome Letter Notification

This is the notification that will generate and send to selected recipients when you send an Outcome Letter. This notification will attach the PDF Outcome Letter.

Outcome Signoff Letter Notification

This is the notification that will generate and send to a user assigned to sign off on an Outcome Letter.

Outcome Signoff Complete Notification

This is the notification that will generate and send to an assigned analyst when all signoff tasks for the letter have been completed.

Outstanding Stipulations Notification

These notifications are sent to the PI, Study Contact, and Assigned Analyst on the defined number of days before the follow up due date defined by the review board for a specific stipulation. There are three notifications shown below as examples in this group of notifications. One is designed to be sent one day before the due date of the stipulation, and the others are designed to be sent five days and 30 days before the due date of the stipulation. These notifications will not be sent if the Review Board has closed the stipulation and assigned a Date Closed prior to the day the notification would be triggered.  

When the review board defines a stipulation, the stipulation type “Comments that must be addressed” causes the Follow-up Due field to appear. The notification will fire based on the Follow-Up Due date provided for the stipulation.

If the study returns the submission correction form with the stipulations addressed and the review board takes an action and assigns a Date Closed before the day that the notification has been set up to send out, then the notification will not be triggered.

Internal Documents Notification

The review board has the ability to upload documents to a study record that are specific to the study and internal to the review board. When documents are uploaded, you have the ability to email that document to another user of the system. Notifications defined here will attach the uploaded document and send to the selected recipient.

From this page you will be able to add the title and define the recipients for the notification.

The recipient of this notification is specified within the notification template, or any additional recipients can be manually added at the time you send the notification. The screenshot below shows an example of a template about to be sent from a study within the review board. The Recipients column pulled in the recipient as defined in the notification setup, and you can manually add additional recipients here.

The notification will send when you access Internal Documents within a study record within the review board. Select the checkbox next to the document you wish to send and then click the Send Email button.

This will cause the Internal Documents Correspondence page to open. You can type in content for the notification, change the recipient list, or change the Subject line for the email. When you are done and ready to send the notification, click on the Save & Send Correspondence button.

List Maintenance Setup

List Maintenance Setup contains a list of configurable dropdown lists available for you to setup. Most of these configuration lists are specific to the IACUC module, but some lists are shared with other review boards and will be noted as such.

Animal Species Configuration List

The Animal Species Configuration List allows you to define the list of species for your institution. Species added to this list can then be pulled in to specific studies.

When you open the Animal Species Configuration List, any current species will be listed. If you want to find a specific Species in this list, you can use the Species Browse / Find field to type in part or all of the Species Name. Click the Find button to filter your results.

To delete any unnecessary Species, click the icon in the Delete column. If you need to delete a Species because it is already listed as a separate record, it is recommended that you use the Merge Species Record feature so that the records are combined and any study records using the unwanted Species will update with the correct Species.

Merge Species

Listed at the top of the page is the Merge Species Records button. This will allow you to manage your list of species by merging duplicate records into one record as needed. Users adding species to a study are able to add a species to the master list if they cannot find the species they need on the study. Merging species allows you to manage the list of user-added species in the case that a species already exists in the master list. To merge species records, click the Merge Species Records button.

A new page will open, listing the available species. Choose two or more records to merge, and then click the Merge Selected Records button.

The page refreshes to list only the species you selected. At this point, you need to indicate which species record to keep by selecting the radio button next to the Species Name. Then, click the Merge button. If you do not want to merge any records, click the Cancel button and you will be returned to the previous page.

When you merge two or more records, the species you selected to keep will remain in the master configuration list and will also be applied to any study records using the other species’ records. Example: the above case is merging two species, “Mouse” and “Mice.” The correct species in the master list is “Mouse;” however, a user added “Mice” to a study, and the species record was created in the master list. When these two records are merged, “Mice” is no longer found in the master list and is replaced by “Mouse” within the study that had referenced “Mice.”

Adding Species to the Master List

If you need to add a Species to the configuration list, click the Add a New Species button. A new page will open, allowing you to input information about the species. Species Name, Scientific Name, and Common Name are required fields. Category Type is optional. When you are finished entering the necessary information, click the Save Changes button.

Any Species you add will then be added to the configuration list.

Functionality

Any Species added to the Animal Species Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the selection of the species, as shown in the screenshot below. The user can click the Add a New Species to the Study button.

A window will open within the browser, allowing the user to search the system for the appropriate species. The user can use the Species Name field to find a particular species; otherwise, leaving that field blank and clicking the Find Species button will return all results.

If the desired species is not found in the list, the user has the option to add a species by clicking on the Add a New Species button.

The window will change, allowing the user to input the same species information gathered when adding a species through the Animal Species Configuration List. Once the necessary information is added, the user will click on the Save Species Info button and the Species will be added to the study as well as the Animal Species Configuration List.

Animal Species Category Configuration List

This configuration list will allow you to specify a pre-defined list of Species Categories that you can then associate with a Species record in the Animal Species Configuration List.

When you open the page, a list of any Species Category previously defined will display. If categories have not yet been added, this page will not list any records. You can click the Add a New Record to add a new Animal Species Category to the list.

When you add a new record, you will need to provide the Species Category name and then click the Save Record button.  The record will be added to the list of Animal Species Categories.

Records can be edited by clicking on the Edit icon next to the name of the category. This will open a new page, allowing you to modify the Species Category.

You can delete a record by clicking the Delete icon next to the record name.

Animal Species Sex Configuration List

This configuration list will allow you to specify a pre-defined list of Animal Species Sex that you can then associate to a species within a study record.

When you open the page, a list of any Animal Species Sex previously defined will display. If records have not yet been added, this page will not list any records. You can click the Add a New Record to add a new Animal Species Sex to the list.

When you add a new record, you will need to provide the Species Sex and then click the Save Record button. The new record will be added to the list of Animal Species Sex.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Animal Species Sex.

You can delete a record by clicking the Delete icon next to the record name.

The Species Sex information is available to end users when adding a species to a study. The screenshot below displays a screen that captures additional study-specific Animal Species detail, with the Species Sex dropdown list highlighted.

Animal Procedure Type Configuration List

This configuration list will allow you to specify a pre-defined list of Animal Procedure Types that you can then associate to a study record.

When you open the page, a list of any Animal Procedure Types previously defined will display. If records have not yet been added, this page will not list any records. You can click the Add a New Procedure Type button to add a new Animal Procedure Type to the list.

When you add a new record, you will need to provide the Procedure Type and then click the Save Procedure button. The record will be added to the list of Animal Procedure Types.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Procedure Type.

You can delete a record by selecting the checkbox next to the appropriate Procedure Type and clicking on the Delete Procedure Type(s) button.

Animal Procedure Configuration List

This configuration list will allow you to specify a pre-defined list of Animal Procedures that you can then associate to a specific species, and then pull that information into a study. You can also capture billing information related to these procedures.

When you open the page, a list of any Animal Procedures previously defined will display. If records have not yet been added, this page will not list any records. You can click the Add a New Procedure to add a new Animal Procedure to the list.

When you add a new record, you will then be able to specify the details for that procedure. Fields marked with an asterisk denote a required field.

Species Name – This dropdown list will contain the species defined in the Animal Species Configuration List. You must choose which species the Procedure applies to. If you have a Procedure that applies to more than one species, you can add additional records with the same information, but associate a different species.

Procedure – This is the name of the Procedure.

Procedure Type – This drop down list will contain the Procedure Types defined in the Animal Procedure Type Configuration List. This allows you to categorize your Procedures.

Procedure Description – This field allows you to describe the Procedure, if necessary.

Is Billable – Select “Yes” if the Procedure is billable. This will allow you to flag a Procedure for billing (if using the ARC Module). If a Procedure is not billable, leave this option set to “No.”

Billing Code – If the Procedure is billable, you may enter the Billing Code in this field.

Cost – If the Procedure is billable, you may enter the Cost of the Procedure in this field.

Administrative Cost - If the Procedure is billable, you may enter the Administrative Cost of the Procedure in this field.

Once you enter the necessary information, click the Save Procedure button.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the details related to the Procedure.

You can delete a record by selecting the checkbox next to the appropriate Animal Procedure and clicking on the Delete Procedure(s) button.

Any Procedure added to the Animal Procedures Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the selection of the procedures, as shown in the screenshot below. The user can click the Add a New Procedure to the Study button.

A window will open within the browser, allowing the user to search the system for the appropriate Procedure. The user can use the Procedure Type drop down list and the Procedure Name field to find a particular Procedure; otherwise, leaving that field blank and clicking the Find Procedure button will return all results.

Note: If more than one Species is specified on the study, the Species Name field in the filters will be presented as a drop down list, allowing you to filter the results based on the desired Species.

You can select a Procedure to add to the study by clicking on the icon in the Select column.

The selected Procedure will display within the form. You can remove the Procedure by clicking on the icon in the Delete Procedure column. You can view additional details related to the procedure by clicking on the icon in the View Description column.

Procedures added to the study can also be pulled in to the Procedure Summary data value, as shown in the screenshot below. Note: The Procedures listed here are only Procedures that have been added to the study first.

If using the Experiment Data Value, the Procedures listed on the study will also display for Common Procedures and Variable Procedures, as shown in the screenshot below.

Animal Service Type Configuration List

This configuration list will allow you to specify a pre-defined list of Animal Service Types that you can then associate to a study record.

When you open the page, a list of any Animal Service Types previously defined will display. If records have not yet been added, this page will not list any records. You can click the Add a New Service Type to add a new Animal Service Type to the list.

When you add a new record, you will need to provide the Service Type and then click the Save Service button. The record will be added to the list of Animal Service Types.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Service Type.

You can delete a record by selecting the checkbox next to the appropriate Service Type and clicking on the Delete Service Type(s) button.

Animal Service Configuration List

This configuration list will allow you to specify a pre-defined list of Animal Services that you can then associate to a specific species, and then pull that information into a study. You can also capture billing information related to these services.

When you open the page, a list of any Animal Services previously defined will display. If records have not yet been added, this page will not list any records. You can click the Add a New Service button to add a new Animal Service to the list.

When you add a new record, you will then be able to specify the details for that service. Fields marked with an asterisk denote a required field.

Species Name – This drop down list will contain the species defined in the Animal Species Configuration List. You must choose which species the Service applies to. If you have a Service that applies to more than one species, you can add additional records with the same information, but associate a different species.

Service – This is the name of the Service.

Service Type – This drop down list will contain the Service Types defined in the Animal Service Type Configuration List. This allows you to categorize your services.

Service Description – This field allows you to describe the Service, if necessary.

Is Billable – Select “Yes” if the service is billable. This will allow you to flag a Service for billing (if using the ARC Module). If a Service is not billable, leave this option set to “No.”

Billing Code – If the Service is billable, you may enter the Billing Code in this field.

Cost – If the Service is billable, you may enter the Cost of the Service in this field.

Administrative Cost - If the Service is billable, you may enter the Administrative Cost of the Service in this field.

Once you enter the necessary information, click the Save Service button.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the details related to the Service.

You can delete a record by selecting the checkbox next to the appropriate Animal Service and clicking on the Delete Service(s) button.

Animal Study Type Configuration List

This configuration list will allow you to specify a pre-defined list of Animal Study Types that you can then associate to a study record.

When you open the page, a list of any Animal Study Types previously defined will display. If records have not yet been added, this page will not list any records. You can click the Add a New Record button to add a new Animal Study Type to the list.

When you add a new record, you will need to provide the Study Type and then click the Save Record button. The record will be added to the list of Animal Study Types.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Study Type.

You can delete a record by selecting the icon in the Delete column.

Anesthetic Configuration List

This configuration list will allow you to specify a pre-defined list of Anesthetic records that you can then associate to a specific Species on a study.

When you open the page, a list of any Anesthetic records previously defined will display. If records have not yet been added, this page will not list any records. You can click Add a New Record to add a new Anesthetic to the list.

When you add a new record, you will first need to select a Species from the drop down list. This list will contain the list of Species configured in the Animal Species Configuration List. Once you select a Species, select the Anesthetic from the dropdown list. If the specific Anesthetic you need to add for this species is not listed, you can create the Anesthetic by typing it in to the Create New field to the right of the Anesthetic drop down list. Associate the Route in the same way; select the proper Route from the drop down list. Otherwise, enter a new record in the Create New field. Once you have selected the appropriate records from the dropdown lists or created new records, specify the Dose and, if applicable, enter Monitoring information. Click the Save Changes button and the record will be added to the list of Anesthetic records.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Species, Anesthetic, Route, Dose, and Monitoring information.

You can delete a record by selecting the checkbox next to the appropriate Anesthetic record and clicking on the Delete Record(s) button.

The Anesthetic records added to the Anesthetic Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Anesthetic, as shown in the screenshot below. The user can click the Add a New Anesthetic to the Study button.

A window will open within the browser, allowing the user to associate Anesthetic information. Because the Anesthetic records have been configured to specific Species, only information associated to the selected Species in the drop down list will display. Also note, that only Species associated to the study will display in the Species drop down list.

Once an Anesthetic is selected for the Species, the remaining supplied information will populate on the page. The user has the ability to change any of this information as needed, and the user can also add any Anesthetic or Route that may not have been configured in the Anesthetic Configuration List.

Once the information has been added, the user will click the Save Anesthetic Info button at the bottom of the window.

The Anesthetic record will display in the table below the Add a New Anesthetic to the Study button. If additional Anesthetic records need to be added to the study, the user can click this button again to repeat the process.

Analgesia Configuration List

This configuration list will allow you to specify a pre-defined list of Analgesia records that you can then associate to a specific Species on a study.

When you open the page, a list of any Analgesia records previously defined will display. If records have not yet been added, this page will not list any records. You can click Add a New Record to add a new Analgesia record to the list.

When you add a new record, you will first need to select a Species from the drop down list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a species, select the Analgesia from the dropdown list. If the specific Analgesia you need to add to this Species is not listed, you can create the Analgesia by typing it in to the Create New field to the right of the Analgesia drop down list. Associate the Route in the same way; select the proper Route from the drop down list. Otherwise, enter a new record in the Create New field. Once you have selected the appropriate records from the dropdown lists or created new records, specify the Dose and Frequency and, if applicable, enter Monitoring information. Click the Save Changes button, and the record will be added to the list of Analgesia records.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Species, Analgesia, Route, Dose, Frequency, and Monitoring information.

You can delete a record by selecting the checkbox next to the appropriate Analgesia record and clicking on the Delete Record(s) button.

The Analgesia records added to the Analgesia Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Analgesia, as shown in the screenshot below. The user can click the Add a New Analgesia to the Study button.

A window will open within the browser, allowing the user to associate Analgesia information. Because the Analgesia records have been configured to specific species, only information associated to the selected Species in the drop down list will display. Also note that only Species associated to the study will display in the Species drop down list.

Once an Analgesia record is selected for the species, the remaining supplied information will populate on the page. The user has the ability to change any of this information as needed, and the user can also add any Analgesia or Route that may not have been configured in the Analgesia Configuration List.

Once the information has been added, the user will click the Save Analgesia Info button at the bottom of the window.

The Analgesia record will display in the table below the Add a New Analgesia to the Study button. If additional Analgesia records need to be added to the study, the user can click this button again to repeat the process.

Stipulation Category

If you would like to categorize your stipulations, you can create a list here and associate a stipulation to a specific category when you create the stipulation. To use categories for stipulations, the review board property rb.use_stipulation_category must be set to “Yes.”

When you open the page, a list of any categories will display. If you have not set up any categories, the page will not list any records. You can add a new category by clicking on the Add a Stipulation Category button.

Type the Stipulation Category name, and click the Save Stipulation Category button to add the new category to the list.

You can edit existing categories by clicking the Edit icon next to the category name. This will open a page that will allow you to modify the name.

Any category you add to the list will populate in the Stipulation Category dropdown list when creating a stipulation for a submission.

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 that 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 information into three fields. Only the first field, “Device Name,” is required. Clicking Save Changes 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 set up 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 a known location on your computer 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 -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.

Restraint Device Configuration List

The Restraint Device Configuration List allows you to add or edit all the Restraint Devices that can be associated to a study record.

After selecting this link, the master list of existing restraint Devices will display. You will have the ability to Edit existing Restraint Devices as well as Merge Restraint Device Records, Add a New Restraint Device, and Delete existing records.

This page contains a Search By filter which allows you to search for specific Restraint Devices within the list.

Add a New Restraint Device

Add a New Restraint Device will allow you to add a new restraint device to the master device list within iRIS. To add a new restraint device, you will need to provide the Restraint Device Name. Optionally, you may include the Restraint Device Mode and Restraint Device Serial Number. After entering the Restraint Device details, click the Save Changes button. Saving the record will update the master device list with the new entry.

Merge Restraint Device Records

Also listed at the top of the page is the Merge Restraint Device Records button. This will allow you to manage your list of Restraint Devices by merging duplicate records into one record as needed. Users adding Restraint Devices to a study can add a Restraint Device to the master list if they cannot find the Restraint Device they need on the study. Merging Restraint Devices allows you to manage the list of user-added Restraint Devices in the case that a Restraint Device record already exists in the master list. To merge Restraint Device records, click the Merge Restraint Devices Records button.

A new page will open, listing the available Restraint Devices. Choose two or more records to merge, and then click the Merge Selected Records button.

The page refreshes to list only the Restraint Device records you selected. At this point, you need to indicate which Restraint Device record to keep by selecting the radio button next to the Restraint Device Name. Then click the Merge button. If you do not want to merge any records, click the Cancel button and you will be returned to the previous page.

When you merge two or more records, the Restraint Device you selected to keep will remain in the master configuration list and will also be applied to any study records using the other Restraint Device records. For example, the above case is merging two Restraint Devices, “Restraint Device 1” and “restraint device 1.” The correct Restraint Device Name in the master list is “Restraint Device 1;” however, a user added “restraint device 1” to a study, and the Restraint Device record was created in the master list. When these two records are merged, “restraint device 1” is no longer found in the master list and is replaced by “Restraint Device 1” within the study that had previously referenced “restraint device 1.”

Restraint Device Functionality

Any Restraint Devices added to the Restraint Device Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the selection of the Restraint Devices, as shown in the screenshot below. The user can click the Add a New Restraint Device to the Study button.

A window will open within the browser, allowing the user to search the system for the appropriate Restraint Device. The user can search using the Device Name, Device Mode, and/or Device Serial Number fields to find a particular Restraint Device; otherwise, leaving that field blank and clicking the Find Device button will return all results.

If the desired Restraint Device is not found in the list, the user has the option to add a Restraint Device by clicking on the Add a New Restraint Device button.

The window will change, allowing the user to input the same Restraint Device information gathered when adding a Restraint Device through the Restraint Device Configuration List.

Once the necessary information is added, the user will click on the Save Device Info button and the Restraint Device will be added to the study as well as the Restraint Device Configuration List.

Drug Configuration List

The Drug Configuration List allows you to add or edit all the Drugs within iRIS that would be available to be associated to a Study, regardless of module.

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

This page contains a Search By filter which allows you to search for specific drugs that has been previously added.

Add a New Drug

Add a New Drug will allow you to add a new drug to the master drug list within iRIS. To add a new drug, you must enter the Trade Name, Generic Name, or Investigational Name. Only one of the three drug names is needed to add a new record to the system. Clicking the Save Changes button will add this drug record and update the master drug list.

Download/Upload Drug

The Download/Upload Drug features give you the ability to 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. The 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.

Once you upload drug records to the list, the system will confirm the number of records listed and they will be displayed in the Drug Configuration List.

Merge Drug Records

Also listed at the top of the page is the Merge Drug Records button. This will allow you to manage your list of Drugs by merging duplicate records into one record as needed. Users adding Drugs to a study are able to add a Drug to the master list if they cannot find the Drug they need on the study. Merging Drugs allows you to manage the list of user-added Drugs in the case that a Drug record already exists in the master list. To merge Drug records, click the Merge Drug Records button.

A new page will open, listing the available Drugs. Choose two or more records to merge, and then click the Merge Selected Records button.

The page refreshes to list only the Drug records you selected. At this point, you need to indicate which Drug record to keep by selecting the radio button next to the Drug. Then, click the Merge button. If you do not want to merge any records, click the Cancel button and you will be returned to the previous page.

When you merge two or more records, the Drug you selected to keep will remain in the master configuration list and will also be applied to any study records using the other Drug records. Example: the above case is merging two Drugs, “Bayer” and “ASPIRIN.” The correct Drug in the master list is “Bayer;” however, a user added “ASPIRIN” to a study, and the Drug record was created in the master list. When these two records are merged, “ASPIRIN” is no longer found in the master list, and is replaced by “Bayer” within the study that had referenced “ASPIRIN.”

Drug Functionality

Any Drug records added to the Drug Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the selection of Drugs, as shown in the screenshot below. The user can click the Add a New Drug to the Study button.

A window will open within the browser, allowing the user to search the system for the appropriate Drug record. The user can use the Drug Name field to find a particular Drug; otherwise, leaving that field blank and clicking the Find Drug button will return all results.

If the desired Drug record is not found in the list, the user has the option to add a Drug by clicking on the Add a New Drug button.

The window will change, allowing the user to input the same Drug information gathered when adding a Drug through the Drug Configuration List. Once the necessary information is added, the user will click on the Save Drug Info button and the Drug will be added to the study as well as the Drug Configuration List.

Euthanasia Method Configuration List

This configuration list will allow you to specify a pre-defined list of Euthanasia Methods that you can then associate to a specific Species on a study.

When you open the page, a list of any Euthanasia Methods previously defined will display. If Euthanasia Methods have not yet been added, this page will not list any records. You can click the Add a New Record to add a new Euthanasia Method to the list.

When you add a new record, you will first need to select a Species from the drop down list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a species, select the Euthanasia Method from the dropdown list. If the specific Euthanasia Method you need to add to this species is not listed, you can create the record by typing it in to the Create New field to the right of the Euthanasia Method drop down list. Associate the Route in the same way; select the proper Route from the dropdown list, or enter a new record in the Create New field. Once you have selected the appropriate records from the dropdown lists or created new records, specify the Dose, and, if applicable, enter Monitoring information. Click the Save Changes button and the record will be added to the list of Euthanasia Methods.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page allowing you to modify the Species, Euthanasia Method, Route, Dose, and Monitoring information.

You can delete a record by selecting the checkbox next to the appropriate Euthanasia Method and clicking on the Delete Record(s) button.

The Euthanasia Methods added to the Euthanasia Methods Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Euthanasia Methods, as shown in the screenshot below. The user can click the Add a New Euthanasia to the Study button.

A window will open within the browser, allowing the user to associate Euthanasia Method information. Because the Euthanasia records have been configured to specific species, only information associated to the selected Species in the dropdown list will display. Also, note that only species associated to the study will display in the Species drop down list.

Once a Euthanasia Method is selected for the species, the remaining supplied information will populate on the page. The user can change any of this information as needed, and the user can also add any Euthanasia Method or Route that may not have been configured in the Euthanasia Method Configuration List.

Once the information has been added, the user will click the Save Euthanasia Info button at the bottom of the window.

The Euthanasia record will display in the table below the Add a New Euthanasia to the Study button. If additional Euthanasia records need to be added to the study, the user can click this button again to repeat the process.

Fluid Extract Configuration List

This configuration list will allow you to specify a pre-defined list of Fluid Extract records that you can then associate to a specific species on a study.

When you open the page, a list of any Fluid Extract records previously defined will display. If Fluid Extract records have not yet been added, this page will not list any records. You can click the Add a New Record to add a new Fluid Extract record to the list.

When you add a new record, you will first need to select a Species from the drop down list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a species, select the Fluid Extraction from the dropdown list. If the specific Fluid Extraction you need to add to this species is not listed, you can create the record by typing it into the Create New field to the right of the Fluid Extraction drop down list. Associate the Frequency in the same way; select the proper Frequency from the drop down list, or enter a new record in the Create New field. Once you have selected the appropriate records from the dropdown lists or created new records, specify the Volume and enter Method of Collection information. Click the Save Record button and the record will be added to the list of Fluid Extract records.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page allowing you to modify the Species, Fluid Extraction, Frequency, Volume, and Method of Collection information.

You can delete a record by selecting the checkbox next to the appropriate Fluid Extract record and clicking on the Delete Record(s) button.

The Fluid Extraction records added to the Fluid Extract Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Fluid Extraction records, as shown in the screenshot below. The user can click the Add a New Fluid Extract to the Study button.

A window will open within the browser, allowing the user to associate Fluid Extract information. Only Species associated to the study will display in the Species drop down list.

Once a Fluid Extraction is selected for the Species, the remaining supplied information will populate on the page. The user can change any of this information as needed, and the user can also add any Fluid Extraction or Frequency that may not have been configured in the Fluid Extract Configuration List.

Once the information has been added, the user will click the Save Fluid Extract Info button at the bottom of the window.

The Fluid Extract record will display in the table below the Add a New Fluid Extract to the Study button. If additional Fluid Extraction records need to be added to the study, the user can click this button again to repeat the process.

Internal Document Category

You can create categories for any Internal Documents you upload to a study within the review board.

When you open the page, a list of any categories will display. If you have not set up any categories, the page will not list any records.

You can add a new category by clicking on the Add a Document Category button.

Type in the Document Category name, and click the Save Document Category button to add the new category to the list.

You can edit existing categories by clicking the Edit icon next to the category name. This will open a page that will allow you to modify the name.

Any category you add will populate in the Category dropdown list when you are uploading a document in the Review Board Internal Documents area within a study.

Internal Routing User Roles

When you are assigning a user to an Internal Routing task, you can specify a role for that user. To use the roles feature, the review board property rb.useReviewRouting_user_role must be set to “Yes.”

When you open the page, a list of any roles will display. If you have not set up any roles, the page will not list any records. You can add a new role by clicking on the Add a User Role button.

Type in the User Role name, and then click the Save User Role button to add the new role to the list.

You can edit existing roles by clicking the Edit icon next to the role name. This will open a page that will allow you to modify the name. To delete a role, check the box next to the record in the list and click Delete Selected Role(s).

Any role you add to the list will populate in the dropdown list next to the user assignment when you are making an Internal Routing assignment for a Submission.

Member Specialty Configuration List

This is where you define the review board member specialties. This list of specialties is available to determine each review board member’s specialty. This list is shared between other review board modules. Any changes made to this list will be reflected across all modules.

You can add a new specialty by clicking the Add a New Record button. You will be able to enter in the Specialty. Once you are finished, click the Save Record button to have the Specialty added to the list.

The specialties can also be edited or deleted here as well.

To delete a record, click the icon in the Delete column. Click the OK button to continue and delete the record(s). Click the Cancel button to cancel the deletion.

To edit, click the Edit icon next to the specialty to be edited and a new page will open. Change the name of the specialty, and then click the Save Record button. The changes will be saved to the record. To return to the list without saving the changes click the Back button.

The Specialty column displays the title of the specialty as it will display for the reviewers to choose from.

The member specialty list is available when adding guests to the meeting attendance in the agenda (see below), as well as being available to choose from when entering information into user accounts.

Paralyzing Agent Configuration List

This configuration list will allow you to specify a pre-defined list of Paralyzing Agents that you can then associate to a specific species on a study.

When you open the page, a list of any Paralyzing Agents previously defined will display. If Paralyzing Agents have not yet been added, this page will not list any records. You can click Add a New Record to add a new Paralyzing Agent to the list.

When you add a new record, you will first need to select a Species from the drop down list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a species, select the Paralyzing Agent from the drop down list. If the specific Paralyzing Agent you need to add to this species is not listed, you can create the record by typing it in to the Create New field to the right of the Paralyzing Agent dropdown list. Associate the Route in the same way; select the proper Route from the dropdown list, or enter a new record in the Create New field. Once you have selected the appropriate records from the dropdown lists or created new records, specify the Dose and, if applicable, enter Monitoring information. Click the Save Changes button and the record will be added to the list of Paralyzing Agents.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page allowing you to modify the Species, Paralyzing Agent, Route, Dose, and Monitoring information.

You can delete a record by selecting the checkbox next to the appropriate Paralyzing Agent and clicking on the Delete Record(s) button.

The Paralyzing Agent records added to the Paralyzing Agent Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Paralyzing Agent records, as shown in the screenshot below. The user can click the Add a New Paralyzing Agent to the Study button.

A window will open within the browser, allowing the user to associate Paralyzing Agent information. Because the Paralyzing Agent records have been configured to specific species, only information associated to the selected Species in the dropdown list will display. Also note that only species associated to the study will display in the Species drop down list.

Once a Paralyzing Agent and Route are selected for the species, the remaining supplied information will populate on the page. The user has the ability to change any of this information as needed, and the user can also add any Paralyzing Agent or Route that may not have been configured in the Paralyzing Agent Configuration List.

Once the information has been added, the user will click the Save Paralyzing Agent Info button at the bottom of the window.

The Paralyzing Agent record will display in the table below the Add a New Paralyzing Agent to the Study button. If additional Paralyzing Agent records need to be added to the study, the user can click this button again to repeat the process.

Predefined Stipulations

If you have a list of commonly used stipulations, you can set them up in Predefined Stipulations.

When you open the Predefined Stipulations page, a list of any predefined stipulations will display. If you have not set up any stipulations, the page will not list any records. You can add a new predefined stipulation by clicking on the Add a New Stipulation button.

If you have set your system to use Stipulation Categories, the Category field will populate at the top of the page containing the list of categories you have created. You can associate the category to the stipulation by making a selection from the dropdown list.

Type in the Stipulation Content and specify an Order, and then click the Save Stipulation button to add the predefined stipulation to the list.

You can edit existing stipulations by clicking the Edit icon next to the record. This will open a page that will allow you to modify the Stipulation Content and the Order.

When you are creating a stipulation for a Submission, you will be able to select the option to Add Pre-defined Stipulation.

Clicking the Add Pre-defined button will open the list of predefined stipulations that exists in the configuration list.

Review Outcome/Outcome Configuration List

Set up the Outcome list for submissions here.

When you open the page, a list of any existing review outcomes will display. If you have not set up any review outcomes, the page will not list any records.

You can add a new review outcome by clicking on the Add a New Action button.

Enter in the Review Outcome name.

You can also specify which flags to apply to this Outcome.

Response Required – When this option is set to “Yes,” the system will return a submission to the study for corrections once this Outcome is set.

Submission Copy Required – When this option is set to “Yes,” the system will place a copy of the submission back into the Not Assigned queue. This setting is typically used to flag Tabled submissions so you can flag a tabled item and then assign it to another meeting from the Not Assigned queue.

Action indicates an Approved Status - When this option is set to “Yes,” the system will flag this submission as Approved and mark any submission form associated to the submission as approved. Note: this does not include study documents; those must be approved and stamped separately.

You can edit existing review outcomes by clicking the Edit icon next to the record. This will open a page that will allow you to modify the Review Outcome.

The list of Review Outcomes will populate in the Review Outcome list in the Outcome tab within the submission processing screens.

Reviewer Rank Configuration List

You can define your reviewer ranks here.

When you open the page, a list of any reviewer ranks will display. If you have not set up any reviewer ranks, the page will not list any records.

You can add a new reviewer rank by clicking on the Add a New Rank button.

Type in the Reviewer Rank and specify whether the rank represents an Ad Hoc reviewer by selecting “Yes” or “No.” You must also specify a number for the rank. Specify 1, 2, 3, or 0 (for Ad Hoc reviewer ranks). These numbers tell the system how to treat the reviewer rank. “1” indicates a Primary Reviewer in the system. “2” indicates a Secondary Reviewer. “3” indicates any other review level. “0” indicates Ad Hoc. Click the Save Reviewer Rank button to add the record to the list.

You can edit existing reviewer ranks by clicking the Edit icon next to the record. This will open a page that will allow you to modify the record.

Reviewer rank populates in the Reviewer Role column when you are assigning a reviewer to a submission.

If the reviewer rank you selected is an Ad Hoc rank, you will be able to select a named board member from the dropdown list in the Reviewer column, or you can type in the first name and last name of the user (for specialty reviewers who do not have a user account in iRIS).

Setup Review Board Stipulation Actions

Review Board Stipulation Actions are applied to Stipulations once a study responds and reports back to the review board. Stipulation Actions determine whether or not the Stipulation can be closed/complete or must be copied and applied back to the study.

When you open the page, a list of any Stipulation Actions will display. If you have not set up any Stipulation Actions, the page will not list any records.

To delete existing Stipulation Actions, click the checkbox next to the item desired and click the Delete Selected Stipulation Action(s) button. To edit a Stipulation Action, click the Edit icon next to the desired Stipulation Action. To add a new Stipulation Action, click the Add a Stipulation Action button.

Type in the Action and specify whether or not to Automatically Copy Stipulation from Previous Submission to Current Submission. This setting controls when the Stipulation should be closed, or, if it has not been addressed, it will be copied to the current submission under review, meaning it will return back to the study again. Choosing “Yes” for this option will cause any Stipulation given this Action to copy and return to the study. Choosing “No” will cause any Stipulation given this Action to be closed. If you would like Stipulations to default to a closed Action without having to manually assign an Action, select the checkbox for Default Stipulation Review Outcome when the Submission is Complete. Click the Save Stipulation Action button to add the record to the list.

Setup Training Courses

The Setup Training Courses page lists the current training courses that a user can be assigned. Training Course information is typically se tup within System Administration; however, the review board can create Training Courses if needed.

To delete a record, click the icon in the Delete column. Click the OK button to continue and delete the record(s). Click the Cancel button and the record will not be deleted.

To edit a course, click the Edit icon next to the course to be edited. After a new page opens, you may change the name of the course, and then click the Save Training Course button to save the changes. Click the Back button to return to the list without saving any changes.

The Course Name column displays the name of the course that will be displayed.

Click the Add New Training Course button to add a course to the list.

Enter the name of the course. Click the Back button to return to the Training Course list page without saving any changes. Click the Save Training Course button to add the course to the Training Course list page.

Business Associate List

The Business Associate List contains a list of the institutions you may 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, 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 Download/Upload the Associate Configuration Template, 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 associate’s name is a required field.

Status – Displays the internal status of the record. Once you save the record, this status changes to an Active status.

Associate Group – Allows the designation of the group the business associate belongs to. 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.

Download/Upload Associate Configuration gives you the ability to easily upload an Excel file with as many business associate records as needed at one time.

Download Associate Configuration Template – This feature will allow you to download a spreadsheet template; this template is set up in the proper format for uploading associate records, with instructions for the input of data in each field. When downloading, be sure to Save the file to a known location on your computer, so the data can be input and saved for future uploading. Below you will find a screenshot of this spreadsheet template.

Upload Associate Configuration– Selecting to upload the device configuration will open a popup window, where you will be able to browse for the correct Excel file containing the associate records you wish to upload.

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 business associate.

Sponsor Type

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 can 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 of 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 that 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.

Click Save Category to save the sponsor type. It will be added to the master list and will be made available to associate to a sponsor record.

Study Document Outcome/Outcome Configuration List

You can create Outcomes for any Study Documents reviewed by the board.

When you open the page, a list of any current Study Document Outcomes will display. If you have not set up any outcomes, the page will not list any records.

You can add a new outcome by clicking on the Add a New Status button.

A new page will open allowing you to input the Outcome Status information.

Create PDF – Set this option to “Yes” if you need the document given this outcome to convert to a PDF. This option should be set to “Yes” for any document that you want to apply your electronic document stamp to. Leave this set to “No” to leave the document as it was submitted.

Once you set Create PDF to “Yes”, three additional options will be available, described below.

Use Approved Stamp – This option will not be available if the Review Board Property “rb.stamp_study_doc” under the Document Processing Category is not on. When this property is on, and the option here is set to “Yes,” then a study document assigned with this outcome will be stamped with an Approval Stamp (stamps can be set up for particular categories in the Review Board Administration).

Use Void Stamp – Setting this option to “Yes” will create a VOID watermark on the study document when it is converted to PDF.

Start From Original Document - This option will specify whether the outcome set and saved will apply to the original document or a PDF already created from the study document outcome being set in the past. This option is applicable if review boards often return to the study document to re-process it and assign it another outcome. For example, when setting a document stamp to void, and a void watermark is stamped, then later on approving the document, this “Start from Original Document” option should be set to “Yes” so that the VOID watermark is no longer present on the document.

When you are finished entering the necessary information, click the Save Study Document Outcome button.

The Study Document Outcomes will populate in the Outcome drop down list when you are approving a Study Document on a study within the submission processing screens.

Study Status Configuration List

This will create and maintain the status for studies as well as 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 moment the study is first drafted until the study is inactive.

The IACUC review board has access to maintain the Study Status list; however, this list is shared between System Administration and any other review board set up in the system. Typically it is the study’s overseeing review board that maintains the study status of a particular study but the IACUC office can have the ability to modify the Study Status for a study if the review board property rb.allow_change_of_study_status is set to “Yes.”

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 for them.

The Sort Order column determines not only how the statuses are grouped here, but also in what order they appear to the Review Board and when viewing studies in Find a Study or My Studies in Study Assistant.  

The 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.

The 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 COI Match 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 submission with a sponsor on the study and the study is in a status that includes the COI check, a Submission 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 a New Study Status button.

The Setup System Study Status page opens. 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 list 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 for Conflict of Interest Match – 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, has indicated a conflict with a sponsor on that study, and the study is in a status that includes the COI check, a conflict match will trigger. *Used with the COI Module

Available to Archive – select “Yes” to indicate whether or not you can archive studies in this status.

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 have access to the study while the study is in this status. If the first checkbox (Allow Study Management Access) is checked, any KSP associated to the study can open the study and make changes. If the second option (Allow Study Management Access But Read Only) 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 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 – With this status active, if this is checked, then KSP can send a submission to the Review Board. If it is not checked, forms cannot be submitted.

Allow Key Study Personnel Change – If this is checked the KSPs associated to the study can be added or removed from the study.

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.

`All the study statuses that are in this list will appear on the Review Board side. In the screenshot above, the IACUC Coordinator will set the status of the study based on the outcome determined in a review board meeting. The dropdown list contains the study statuses. The study status appears along with the Study Title and Expiration Date for the study in the header.

The study status will also appear next to studies when you are in Find a Study both on the Review Board side and Study Assistant. The screenshot above is for Find a Study on the IACUC Assistant and lists all of the studies for a particular Principal Investigator.

The study status also shows in any screen associated with a study.

Within the IACUC Review Board, if the review board property rb.allow_change_of_study_status is set to “Yes,” you will be able to change the study status for a particular study by accessing the study through Find A Study. Navigate to the Study Summary/Profile and the Study Status drop down list will be available for you to set.

Substance Configuration List

This configuration list will allow you to specify a pre-defined list of Substances that you can then associate to a specific species on a study.

When you open the page, a list of any Substances previously defined will display. If Substances have not yet been added, this page will not list any records. You can click the Add a New Record button to add a new Substance to the list.

When you add a new record, you will first need to select a Species Name from the drop down list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a Species Name, select the Substance from the drop down list. If the specific Substance you need to add for this species is not listed, you can create the record by typing it in to the Create New field to the right of the Substance dropdown list. Associate the Route in the same way; select the proper Route from the dropdown list. Otherwise, enter a new record in the Create New field. Once you have selected the appropriate records from the dropdown lists or created new records, specify the Dose and enter the Frequency, Expected Effect, and Possible Side Effect information. Click the Save Changes button, and the record will be added to the list of Substances.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Species Name, Substance, Route, Dose, Frequency, Expected Effect, and Possible Side Effect information.

You can delete a record by selecting the checkbox next to the appropriate Substance record and clicking on the Delete Record(s) button.

The Substance records added to the Substance Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Substance records, as shown in the screenshot below. The user can click the Add a New Substance to the Study button.

A window will open within the browser, allowing the user to associate Substance information. Because the Substance records have been configured to specific species, only information associated to the selected Species in the dropdown list will display. Also note that only species associated to the study will display in the Species drop down list.

Once a Substance and Route are selected for the Species, the remaining supplied information will populate on the page. The user can change any of this information as needed, and the user can also add any Substance or Route that may not have been configured in the Substance Configuration List.

Once the information has been added, the user will click the Save Substance Info button at the bottom of the window.

The Substance record will display in the table below the Add a New Substance to the Study button. If additional Substance records need to be added to the study, the user can click this button again to repeat the process.

Strain Configuration List

This configuration list will allow you to specify a pre-defined list of Species Strain records that you can then associate to a study.

When you open the page, a list of any Species Strain records previously defined will display. If Species Strain records have not yet been added, this page will not list any records. You can click Add a New Record to add a new Species Strain to the list.

When you add a new record, you will first need to select a Species Name from the drop down list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a Species Name, enter the Strain. Click the Save Changes button, and the record will be added to the list of Strains.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Species Name and Strain.

You can delete a record by selecting the checkbox next to the appropriate Species Strain record and clicking on the Delete Record(s) button.

The Strain records added to the Strain Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Strain records, as shown in the screenshot below. The user can click the Add a New Strain to the Study button.

A window will open within the browser, allowing the user to associate Strain information. Because the Strain records have been configured to specific species, only information associated to the selected Species in the drop down list will display. Also, note that only species associated to the study will display in the Species drop down list.

Once a Species and Strain are selected, the remaining information can be input on the page. The user can change any of this information as needed, and the user can also add any Strain that may not have been configured in the Strain Configuration List.

Once the information has been added, the user will click the Save Strain Info button at the bottom of the window.

The Strain record will display in the table below the Add a New Strain to the Study button. If additional Strain records need to be added to the study, the user can click this button again to repeat the process.

IACUC Drug Configuration List

The IACUC Drug Configuration List allows you to add or edit drug records specific to the IACUC. These IACUC Drug records can be associated to an IACUC study.

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

This page contains a Search By filter which allows you to search for specific drugs that have been previously added.

Add a New IACUC Drug

Add a New IACUC Drug will allow you to add a new drug to the master IACUC Drug list within iRIS. To add a new drug, you must enter the Trade Name, Generic Name, or Investigational Name. Only one of the three drug names is needed to add a new record to the system. Clicking the Save Changes button will add this drug record to the master IACUC Drug list.

Merge IACUC Drug Records

Also listed at the top of the page is the Merge IACUC Drug Records button. This will allow you to manage your list of IACUC Drugs by merging duplicate records into one record as needed. Users adding IACUC Drugs to a study can add a drug record to this master list if they cannot find the IACUC Drug they need on the study. Merging IACUC Drugs allows you to manage the list of user-added IACUC Drugs in the case that an IACUC Drug record already exists in the master list. To merge IACUC Drug records, click the Merge IACUC Drug Records button.

A new page will open, listing the available IACUC Drugs. Choose two or more records to merge, and then click the Merge Selected Records button.

The page refreshes to list only the IACUC Drug records you selected. At this point, you need to indicate which IACUC Drug record to keep by selecting the radio button next to the IACUC Drug. Then, click the Merge button. If you do not want to merge any records, click the Cancel button and you will be returned to the previous page.

When you merge two or more records, the IACUC Drug you selected to keep will remain in the master configuration list and will also be applied to any study records using the other IACUC Drug records. Example: The above case is merging two drugs, “IACUC Drug1” and “IACUC drug 1.” The correct IACUC Drug in the master list is “IACUC drug 1;” however, a user added “IACUC Drug1” to a study, and the IACUC Drug record was created in the master list. When these two records are merged, “IACUC Drug1” is no longer found in the master list, and is replaced by “IACUC drug 1” within the study that had referenced “IACUC Drug1.”

IACUC Drug Functionality

Any IACUC Drug records added to the IACUC Drug Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the selection of the Drugs, as shown in the screenshot below. The user can click the Add a New Drug to the Study button.

A window will open within the browser, allowing the user to search the system for the appropriate Drug record. The user can use the Drug Name field to find a particular drug; otherwise, leaving that field blank and clicking the Find Drug button will return all results.

If the desired Drug record is not found in the list, the user has the option to add a Drug by clicking on the Add a New IACUC Drug button.

The window will change, allowing the user to input the same Drug information gathered when adding a Drug through the Drug Configuration List. Once the necessary information is added, the user will click on the Save Drug Info button and the Drug will be added to the study as well as the Drug Configuration List.

Tranquilizing Drug Configuration List

This configuration list will allow you to specify a pre-defined list of Tranquilizing Drugs that you can then associate to a specific species on a study.

When you open the page, a list of any Tranquilizing Drugs previously defined will display. If Tranquilizing Drugs have not yet been added, this page will not list any records. You can click Add a New Record to add a new Tranquilizing Drug to the list.

When you add a new record, you will first need to select a Species Name from the dropdown list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a Species Name, select the Tranquilizing Drug from the dropdown list. If the specific Tranquilizing Drug you need to add to this species is not listed, you can create the record by typing it in to the Create New field to the right of the Tranquilizing Drug drop down list. Associate the Route in the same way; select the proper Route from the drop down list. Otherwise, enter a new record in the Create New field. Once you have selected the appropriate records from the dropdown lists or created new records, specify the Dose, and enter the Monitoring information. Click the Save Changes button, and the record will be added to the list of Tranquilizing Drugs.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page allowing you to modify the Species Name, Tranquilizing Drug, Route, Dose, and Monitoring information.

You can delete a record by selecting the checkbox next to the appropriate Tranquilizing Drug record and clicking on the Delete Record(s) button.

The Tranquilizing Drug records added to the Tranquilizing Drug Configuration List will be available to add to an IACUC study. Within the IACUC Application, users will be presented with a data value that will allow the association of Tranquilizing Drug records, as shown in the screenshot below. The user can click the Add a New Tranquilizing Drug to the Study button.

A window will open within the browser, allowing the user to associate Tranquilizing Drug information. Because the Tranquilizing Drug records have been configured to specific species, only information associated to the selected Species in the drop down list will display. Also, note that only species associated to the study will display in the Species dropdown list.

Once a Tranquilizing Drug and Route are selected for the Species, the remaining supplied information will populate on the page. The user can change any of this information as needed, and the user can also add any Tranquilizing Drug or Route that may not have been configured in the Tranquilizing Drug Configuration List.

Once the information has been added, the user will click the Save Tranquilizing Drug Info button at the bottom of the window.

The Tranquilizing Drug record will display in the table below the Add a New Tranquilizing Drug to the Study button. If additional Tranquilizing Drug records need to be added to the study, the user can click this button again to repeat the process.

USDA Class Configuration List

USDA Classes can be configured and then associated to IACUC study records in the system. You can manage the current list of USDA Class records by accessing this page.

When you open the page, a list of any USDA Class records previously defined will display. If USDA Class records have not yet been added, this page will not list any records. You can click the Add a New Record button to add a new USDA Class record to the list.

When you add a new record, you will need to enter the USDA Class and click the Save Changes button. The record will be added to the list of USDA Class records.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the USDA Class information.

You can delete a record clicking the icon in the Delete column.

USDA Class information can be set for a specific study within the Outcome tab of the Submission Processing screens.

This information will also display within the Study Profile.

Vaccination Configuration List

Vaccination records can be configured and then associated to IACUC study records in the system. You can manage the current list of Vaccination records by accessing this page.

When you open the page, a list of any Vaccination records previously defined will display. If Vaccination records have not yet been added, this page will not list any records. You can click the Add a New Record to add a new Vaccination record to the list.

When you add a new record, you will first need to select a Species Name from the drop down list. This list will contain the list of species configured in the Animal Species Configuration List. Once you select a Species Name, enter the Vaccination information. Click the Save Changes button, and the record will be added to the list of Tranquilizing Drugs.

Records can be edited by clicking on the Edit icon next to the name. This will open a new page, allowing you to modify the Species Name and Vaccination information.

You can delete a record by selecting the checkbox next to the appropriate Vaccination record and clicking on the Delete Record(s) button.

Vaccination Records added to the Vaccination Record Configuration List are available to associate to users within IACUC’s User Vaccination History. For more information, see the IACUC Assistant Manual.

Issue Reporting Types

The Issue Reporting Types page lists the current issue types that can be assigned to the study.

You can add a new Issue Type by clicking the Add an Issue Type button.

This will bring you to the Issue Type setup page. You will be required to enter the order number and the issue type. Once you have entered this information, click the Save Item Order button and the issue will be added to the Issue Type List.

You can add the issue to a study from the Study Summary information page from the Miscellaneous menu tab on the submission processing screens. Once you are on the Study Summary page, click the Add button next to the Study Issue Report section.

This will open the study issue reporting details window, where you can specify the Issue Type, Issue Date, and Issue Details. After you are done entering the Issue details click the Save Details button to add the issue to the study.

Clean-up

This tab within Review Board Administration contains a link that will allow the review board administrator to transfer tasks from one staff member to another. In addition, the Document Management functionality allows you to

Transfer Outstanding Tasks

This area allows you to reassign a user’s incomplete tasks to another user. This can be used when an IACUC Coordinator leaves the institution and all their tasks needed to be transferred to their replacement.

To use this option, click the Transfer outstanding tasks link. This will populate a new page where you can select the user whose tasks need to be transferred. The system will pull all their incomplete tasks and put them in a list:

Then, check the box next to the tasks desired for transfer and select the user that will accept these tasks from the dropdown menu.  Click the Transfer Task to New User button at the top right of the screen.

The user who has accepted the tasks will be able to open and complete the task from their home screen.

Document Management

The Document Management functionality allows you to manage the documents associated with a study.

When you click the link, you will be brought to the IACUC – Find a Study screen. You can use the filters at the top of the screen to locate the study you wish to manage documents for. In the screenshot below, the IACUC Number filter was used to find a study. Enter the desired search terms in the Find a Study Filters and click Find.

Click the in the record for the study you wish to open. This will bring you to the Document Management screen. Different review boards may also want to select Consent documents on this screen, which can be selected using the Document Type radio button. You can also filter by document/consent Category, Version Number, Approval Date range, document Title, Document Outcome, and Expiration Date range.

In the Select Root Document column, you will see all the study documents associated with the study you selected that are version 1.0. These are the root documents that you will be merging other documents into. Click the icon next to the document that you wish to be your root document.

Checkboxes will populate in the Select Document column, allowing you to select the document(s) that you wish to merge with the root document.

Make your selection(s), and click Prepare Changes. 

The following window will open. Here, you can see that the versions of the document you selected as your root document are already selected for you. The documents called “ACORP Diagram”, which you selected with checkboxes in the previous step, are listed below the root versions with unchecked boxes next to them, which you can select if you decide to merge these documents into the root document.

The columns in this window are as follows:

Document Title – When the window first opens, this field displays the original names of the documents. These are editable if you wish to change the name of any of your document versions.

Current Version – This column lists the current versions of the documents in the list.

Proposed Version – This column displays the suggested versions of the documents once they have been merged. These are editable if you wish to change any of the current version numbers.

Category – This column shows that all listed documents have been associated with the category of the root document.

In the scenario in the screenshot above, you can check the boxes next to the two documents titled ACORP Diagram to select them to merge with the versions of the root document. If you wish for these versions to have the same name as the root document, change their names in the Document Title field.

Click Merge Documents to proceed.

This opens the Prepare Changes window, where you can view the proposed changes to the documents. Click Confirm to continue with the merge, or Cancel if you do not wish to proceed. A dialog will open; click OK to confirm the action or Cancel if you do not wish to reorganize the documents.