IACUC Assistant Overview

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

The IACUC Assistant is available to streamline and assist in an institution’s entire Review Board management. The IACUC Assistant works similarly to other review boards. The IACUC Assistant is used during the process of submission reviews, signoffs, member reviews, meetings and more.

Find a Study

The Find a Study item allows users to search the entire system for studies. Find a Study is a tool used by System Administrators and IACUC Coordinators, allowing them to search the system for certain studies. Depending on system settings, Find a Study within IACUC Assistant may or may not allow the search to expand across the entire system; it may be configured to search only for studies within the IACUC.

You are able to use the available filters to search for a study or you can click the Find button to return all studies in the system.

You can also change the display of the study numbering by selecting from the Display Projects By drop-down list. The numbers available here depend on what modules are configured in to your system. The example below shows the page when IACUC Number is selected from the drop-down list. The page reflects IACUC information, as opposed to the default, IRB Number information.

Some of the search fields are auto-populating fields. You begin by typing the name, and the system returns any resulting matches for you to select. Sponsor, Principal Investigator, Department, and IACUC Number are all auto-populating fields.

The Principal Investigator field allows you to flip between Active and Inactive PI’s. Inactive PI’s are any user accounts in the system that have been flagged as Inactive and are also listed as Principal Investigators on studies. Active PI’s are any user accounts that are flagged as Active and also are listed as Principal Investigators on studies.

Also available are dropdown menus of available Study Statuses and Study Classifications that you can choose from.

The Reference Number field allows you to search for studies by Submission Reference Number. Enter a reference number for a specific submission form. When you filter the results, the study matching the reference number will populate in the results.

Note: You must enter the entire Reference Number in this field, except for the leading zeros. Example, a submission is Reference Number “000288” you would need to enter “000288” or “288” to filter the results correctly.

You can search by an expiration date range by entering in the appropriate information in the IACUC Expiration Date and IACUC Full Renewal Expiration fields.

Reset Find Options – This button will allow you to reset the study filters and begin a new search.

For more advanced search options, click on the Advanced Search Options button.  

This allows you to filter by study drugs, devices, issue reports and key words in the Study Title. You can choose to use one or all options in the Advanced Search Options by selecting an item from a drop-down list and/or typing in the keywords. When you are finished, click Apply.

When you click the Find button, the system will return any matching studies, depending on the filters you selected. If you added Advanced Search Options, the button will update with a yellow border to indicate extra filters are in use.

Once you find the study you are looking for, you can click the icon in the Open column to open the study record.

The other columns on this page are as follows:

Study Status - This displays the current status of the study (i.e. Open, Pending, Draft, Completed).

IACUC Number- If an IACUC Number has been associated with a study, it displays here. This column changes to whatever you choose to display the studies by, when you are using the “Display my Projects by:” filter.  

IACUC Expiration Date- If an expiration date is associated with a study, it displays here. This column also changes with whatever you choose to display the projects by, when using the filters.  

IACUC Full Renewal Expiration – If a Full Renewal Expiration date has been associated to the study, it displays here. This column will not display if you choose to display the projects by another type of number, using the filters.

 

Study Title- This displays the Study Title given to the study in the initial section of the Study Application.

Study Number- This displays the Study Number/Nickname given to the study in the initial section of the Study Application.

Principal Investigator- This displays the name of the Principal Investigator on the study.

Sponsor – This displays the name of the Sponsor on the study.

To view a study, click the icon in the Open column and you are brought to the Study Management page. By default, this page opens to the Submissions tab, which looks similar to the screen shot below.

The Submissions tab displays any forms available for viewing by the IACUC. These are typically items that have been submitted for review previously. You can also access the study’s Other Study Documents, view Submission History, and view Study Correspondence from this tab.

From the Submissions History Link, you can track the workflow of the initial submission and any other submission forms processed by the review board (as seen in the screenshot below).

Clicking on the Study Correspondence link provides you with a list of all notifications, signature requests, and notices that pertain to the Study (see screenshot below).

If there are any outstanding submissions that are awaiting approval or signoff, they appear in the Outstanding Submission(s). Here you can see the location of the submission within the workflow, you can edit/view the submission, or you can Retract Submission.

Clicking on the Study Management tab brings you to a screen where you can access all information regarding the Study.

By selecting the icons under one of the main headings (e.g. Study Details, Sponsors & Subrecipients, you are linked to various information that is complete for this particular Study.  

The Study Summary/Profile link contains basic information about the study such as personnel, review board information, study details, etc. The screenshot below should look similar to your Study Summary screen, but might contain extra fields about the study. Certain fields may or may not be in use and are turned on or off in the System Configuration Properties.

Submissions

The Submissions menu item allows you to view all submissions sent to the IACUC, as well as process those submissions. Your instance of iRIS may display either Submissions or Committee Submissions in the IACUC Assistant list, depending on how your system is set up (Review Board property “rb.use_submission_by_committee”. See the IACUC Assistant – Properties manual for more information).  

When you click on the Submissions or Committee Submissions link, a page opens displaying all submissions, divided into four tabs: Not Assigned, Assigned, Completed, and Agendas. Upon opening the Submissions link, the system automatically defaults to the Not Assigned tab. Information regarding each submission populates in sortable columns so you can easily view as well as search for pertinent information pertaining to individual submissions. See the IACUC Assistant - Submission Processing manual for more information.

Analyst Dashboard

The Analyst Dashboard allows you to search for and access studies in the system. Within the Analyst Dashboard you can view your specific analyst assignments and open the associated submissions, which will allow you to access study-related information, determine a review process, assign reviewers, add stipulations, designate a submission outcome and approval dates, generate outcome letters, access upcoming meeting dates, and more. You can also view the agendas for upcoming and past meeting dates.

See the IACUC Assistant - Analyst Dashboard manual for more information.

Reviewer Assignment

The Reviewer Assignment area of IACUC Assistant allows you to view and open your current Incomplete and Complete reviewer assignments. By default, the Reviewer Assignment screen opens to the Incomplete tab.

By clicking the icon in the “Click to open” column, you will be directed to your reviewer assignment. You can choose to display submissions by IACUC Number or by another type of study numbering using the “Display Submissions by:” dropdown menu.  

On the Complete tab, you can enter a number in the “Reviews Completed within the last:” text box. This will determine how far back your completed review assignments will be displayed. Opening an assignment will take you to your completed form.

Reviewer Dashboard

Reviewer Dashboard allows you to access any submission you have been assigned to review, access internal submission routing assignments, and review any upcoming meetings.

See the IACUC Assistant – Reviewer Dashboard Manual for more information.

Meeting Management

Meeting Manager

Meeting Manager allows you to view meeting agendas, set meeting availability, and set items to be reviewed at the meeting. Access to this menu item is controlled through the Role Access Matrix in Review Board Administration. The Meeting Manager is typically reserved for a review board administrator. You can view current agendas and publish/create Word document versions of Agendas and Meeting Minutes to send to board members. The Agenda and Meeting Minutes templates are created in Review Board Configuration. For more information on creating Agenda and Minutes templates, see the IACUC Assistant – RB Administration Manual.

See IACUC Assistant - Meetings Manual for more information on how to manage meetings within Meeting Manager.

Meeting Agenda

Meeting Agenda allows you to view information related to a specific meeting date. You can access past and future meetings from this area. If you have a review board administrator role, come to this area to prepare for an upcoming meeting. If your role does not have this administrative privilege, come to this area to look at submissions placed on a particular meeting date. Read/write access for the meeting agenda is configured in Setup Role Access in Review Board Administration.

The meeting agenda page will open to the next upcoming meeting. Flip to a different meeting date by clicking on the arrows by the meeting date at the top of the page. See the IACUC Assistant - Meetings manual for more information.

Meeting Minutes

Meeting Minutes allows you to access published meeting minutes for any past meeting. This is an area where board members go to pull minutes from a past meeting.

This page displays a link for each board meeting that has been held from newest to oldest. If minutes have been generated and a Finalized version has been published, a View Finalized Minutes button populates next to the meeting link. If a Draft version of the minutes has been published, the button reads View Draft Minutes. If the meeting minutes have not been published yet, no button displays. You can click on the View Finalized Minutes or View Draft Minutes button to view the PDF document for that meeting. You can also open to the meeting agenda by clicking the link reading the meeting name and meeting date.

When you click to view the draft or finalized minutes, they open in a new screen displaying the information entered from the meeting. The fields in the minute’s document reflect what was defined in the Meeting Minutes Template. If it is a Draft version of the minutes, a watermark appears with the word DRAFT across the minutes. See IACUC Assistant - Meetings Manual for more information.

Meeting Availability

The Meeting Availability tool allows a user to indicate their availability for any future board meetings.

If you log in to Meeting Availability as a system administrator, each meeting date appears on a single page. Each member of the board displays on the page with three columns to the right of their name. You can set a member’s availability for a certain meeting date by marking a response in the three columns.

Will be Present – Select this if the member will be at the meeting.

Will Not be Present – Select this if the member will not be attending the meeting. If this selection is flagged, the user’s name will flag in Member Attendance on the Meeting Agenda page that they may not be present.

Available for Review – If a member has indicated that they will not be available for reviewer assignments, set this from “Yes” to “No”. When a member indicates they are unavailable for review, their name will be removed from the Reviewer Assignments area for any submission associated to this meeting date.

If you log in a non-review board administrative role, when you view this page, you will only be allowed to set your availability for upcoming meetings.

Each meeting is listed with the same options – Will be Present, Will Not be Present, and Available for Review. Another column, View Calendar, is also available.

Clicking this icon opens a new window with a calendar view displaying the month of the meeting. Click the Close button when you are finished viewing the calendar.

After setting your availability for a meeting date, be sure to click the Save the Availability button.

Monitoring

Continuing Review Monitor

Continuing Review Monitor allows you to access the study management page of the submissions that are up for continuing review and full renewal expiration. Submissions that are within 120 days of their continuing review date populate in this list.

Display the list by the IACUC number, IRB Number, or IBC Number (depending on which modules are setup in your instance of iRIS) by selecting the desired option from the Display By: drop down list. The Study Title/Study Number, IACUC Number (or other selected number from Display By), IACUC Initial Approval, IACUC Expiration, Full Renewal Expiration, Principal Investigator, and whether the Submission Posted displays for each study in the list.

This list allows your IACUC team to monitor any studies coming up for Full Renewal, as well as take action on any study that missed the Full Renewal deadline. A study record displays in this list until the study record is updated by either closing it for lack of a Continuing Review or Full Renewal submission or updating the IACUC Expiration date to a later date.

Clicking the Open icon next to any submission brings you to the Study Management Page.

From here you can access the Study Profile, which allows you to make any necessary changes to the study record.

Outstanding Responses

Outstanding Responses allows you to manage submissions that have been sent back to the PI for corrections.

The Outstanding Responses menu group provides a way for the Coordinator to manage submissions that were sent back to the KSP for changes. The determination of a submission status is set in the Outcome tab (see box below). Here the status of the Review Outcome, along with a “Yes/No” for Additional Information Required, is set. If a submission has an outcome with Additional Information required set to “Yes,” then this submission remains in Outstanding Responses until a new version of the submission is received.

The submissions in the list can be displayed by their IACUC Number or other type of study number (depending on which modules are setup in your instance of iRIS). Other Outstanding Response Filters can be used at the top of the screen to narrow down your results. You can search by Form, which will list all of the submission, submission correction, and submission response forms in your iRIS system. You can also search by the Analyst or Reviewer assigned to the submission, as well as submission outcomes.

There are also date range fields that you can use to search for submissions based on the Follow-Up Due date and the Date Sent. Enter a beginning and end date to search for submissions that fall within a particular date range. After you have set your desired filters, click the Find button. To start your search over, click Reset Find Options.

Click on the icon to access the original submission; this icon will take you right to the Outcome tab of the submission. From here, you can track the location of the submission, status the submission, or send correspondence to the KSP.

The following columns populate for the submissions:

Letters - If an outcome letter was created and sent, an icon appears in this column. Hover the mouse over the icon and the type of letters will appear (see below).

Outcome - The review outcome/ status of the submission.

IACUC Number - The review board number used to reference the study.

Ref Number - The iRIS-generated reference number for the submission.

Type – The type of submission form.

Follow-up Due - The follow-up date associated to the submission, if any.

Principal Investigator - The Principal Investigator assigned to the study.

Department / Study Number – The Primary Department and Study Number associated to the study populates in this column.

Analyst Assigned – The analyst, if any, assigned to the submission.

Reviewer(s) - The reviewer(s), if any, that were assigned to the submission.

Meeting Date - If the submission was put on the agenda, the meeting date displays here.

Stipulations Tracking

Stipulations Tracking allows you to track and edit the stipulations for each submission.

When clicking on the Stipulations Tracking icon in the menu, you will be brought to a screen similar to the one below.

The stipulations display by Open Stipulations and Closed Stipulations tabs. You can filter the stipulations using the options at the top of the screen in either tab. You have the ability to filter by the Review Board Number (which depends on the selection made from the Display by dropdown), Reference Number, Follow-up Date Range, and Stipulation Type. Display the stipulations by one of the following: IACUC Number, Proposal Number, or IBC Number (or other review board numbers depending on the configuration of the dropdown list).

The columns in the Open Stipulations tab display as follows:

IACUC/IRB/IBC Number – The review board number assigned to this study displays in this column.

Ref Num – The submission’s reference number displays in this column.

Type – This column displays the type of submission form in which this stipulation was entered.

Principal Investigator – The Principal Investigator associated with this study displays here.

Stipulation Type – The type of stipulation displays here.

Follow-up Due – If the stipulation type is “Comments that must be addressed”, then this area populates with the date that the follow-up is due.

Response Acknowledge – This area displays whether or not the PI accepted the stipulation.

The actual Stipulation entered by the Review Board and the Response from the study side displays in the green highlighted area. Note: Study Management will NOT be able to create a Response to the stipulations if the submission has not been returned to the study by the review board.

Select the Open icon next to the appropriate stipulation to open the submissions screen (shown below).

Selecting the Edit icon opens the Process Stipulation screen (shown below). From this area you can choose a Review Board Action and provide a date that the stipulation was closed in the Review Board Date Closed field.

You can also add memos to the stipulation. Click the Add Memo button. A new page opens, allowing you to enter the text for the memo. Click the OK button when you are done.

The memo adds to the Stipulation record. Memos allow you to keep a log of comments from different review board users with information specific to the Stipulation. When you are finished setting information on this page, click the Save Stipulation button to return to the Stipulations Tracking page. If you entered a Review Board Action and a Review Board Date Closed, the Stipulation moves from the Open Stipulations to the Closed Stipulations tab.

Select the Closed Stipulations tab. A screen similar to the Open Stipulations tab displays, listing all of the stipulations that have been closed (see below).

Two additional columns appear in the Closed Stipulations tab – Action and Date Closed. The information in these columns populated with the selections made in the Process Stipulation screen as explained above. The submissions corresponding to the stipulation can be opened or edited here as well, as previously explained.  

Correspondence and Notifications

Correspondence

The Correspondence tool allows you to view all IACUC correspondence that has been sent out through the system as well as add and reply to correspondence.  

The Correspondence menu group is typically available only to Review Board Coordinators and Administrators. However, read/write access can be granted to any role on the board through Review Board Administration – Setup Role Access.

Clicking the Correspondence icon brings you to the following screen. Any correspondence generated through the IACUC Assistant module or sent to the IACUC Assistant module creates a log within this screen.

View Message – Click on this icon next to the correspondence you want to view. The correspondence displays in read-only format. The subject title, IACUC Number, the recipients of the correspondence, additional recipient(s) and attachments that might be included with the correspondence also display here.  

To reply to a correspondence, select the Post a Reply to this Topic link above the correspondence. A new page displays (see below).

Send Email – When checked, this correspondence is sent to the recipients via email as well as posting to the Correspondence area under My Assistant. If your reply should not be sent as an email, deselect the checkbox.

Subject – This displays in the subject field of the correspondence. This is modifiable.  However, since this is a reply, it defaults to the original correspondence’s subject.

IACUC Number – If this correspondence is associated to a study, the IACUC Number of that study displays here.

Recipient(s) – The recipient(s) of the correspondence displays here. This is pre-populated with prior recipient(s) and/or author of the original correspondence EXCEPT if the recipient/author is the current user. This field is required and can be configured by selecting the heading link. A new page displays (see below).

If the correspondence was associated to a study, the Key Study Personnel are listed. User roles are listed with a checkbox next to each. To add personnel to the recipient’s list, select the checkbox next to the appropriate user. You may select or unselect all by clicking on the Select All icon above the checkboxes. After the appropriate user(s) have been selected, click on the Save Changes button.

Additional Recipient(s) – Select this link to send this correspondence to person(s) outside of iRIS. A new page displays when this link is selected. (See below.)

Select the Add A New Contact button. A new row will appear, allowing you to add the contact information.  (See screenshot below.)

The Name and E-mail Address fields are both required. Note: The E-mail address must be entered in the name@domain.com format or an error message will display.

You may add more contacts by repeating the steps above. Delete a contact by selecting the checkbox next to the appropriate contact(s) and clicking the Remove Selected Contacts button.

After the appropriate contacts have been entered, select the Save and Return button. Note: If this button is not selected, any changes made will not be saved.

Reply To(s) - This list is the group of users that will be placed in the recipients list when a reply is posted to this correspondence, either from iRIS or from an inbox.

Additional Reply To(s) - This is the group of users that will be placed in the additional recipients list when a reply is posted to this correspondence, either from iRIS or from an inbox.

Attachments – Select the Add Attachments button to add any documents to the correspondence. A new page displays allowing you to upload the document.

A Title must be entered for the attachment. Select the Upload button to upload the document. The upload dialog box displays. (See below.)

Select the Browse button to look for the document to be uploaded on your computer. Select the OK button after the document is located or select the Cancel button to cancel the upload. After the appropriate document is uploaded, select the Save and Return button. This section appears as displayed in the screenshot below.

Select the attachment name or icon to view the attachment. To delete an attachment, select the checkbox next to the appropriate attachment(s) then select the Delete Attachment button. You may add more attachments by selecting the Add Attachment button again. Note: Though there is no limit on the size of the documents uploaded, certain email systems will have a limit on the size of incoming mail; therefore it is advisable that the uploaded documents do not exceed a total of 1 MB when sending the correspondence as email.

Content – Enter the content of the correspondence here.

Select the Save and Send Correspondence button when you are finished entering the necessary information, or click Save Correspondence as a Draft to save your message to send later. The correspondence appears directly above the original correspondence.

Forward a correspondence record by clicking the Forward this Topic link, located next to the Post a Reply to this Topic link.

When you forward a correspondence, a page similar to the one shown below opens. The Content of the correspondence pulls in the original correspondence Content, allowing you to add to the Content before sending. The fields provided in this area are the same as described above. Before you forward the correspondence, you need to select a Recipient.

To add a new correspondence, select the Add a New Correspondence button. This displays a page similar to the Post a Reply page, except there is no pre-populated data.

Except for correspondence that is sent out as email, the correspondence may be deleted only when they are first created and saved as a draft. You will NOT be able to delete correspondence that has been sent out as an email at any time. A checkbox will appear next to the correspondence indicating that it may be deleted. Select the checkbox and click on the Delete Selected Correspondence button.

Drug/Device Email

The Drug/Device Email tool allows you to send a study-related drug or device email to the contacts of that study. To begin, click on the Drug/Device Email link in your IACUC Assistant. Access to this menu item is controlled for certain roles through the Review Board Administration - Role Access Matrix.

Note: This tool is typically used for pharmaceutical recalls, or notes that need to go out to all Study Contacts who are utilizing a specific drug or device.

A user can search for the drug/device from one of the four drop down menus: Select a Drug by Trade name, Select a Drug by Generic name, Select a Drug by Investigation name, or Select a Device. Once you have made your selection from the dropdown menu, all studies associated with your selection populate with a checkbox next to each one. Click the checkbox next to the study you wish to send an email regarding. Enter in a Subject and any necessary content. When you have finished, click the Send Email button in the upper right hand corner.

This triggers the email and all study contacts on the selected studies will receive the drug/device related email.

Audit System Notifications

The Audit System Notifications tool allows you to search through and view system notifications.

The Audit System Notifications menu item is usually accessible to Review Board Coordinators and Administrators.  However, its accessibility is controlled for all roles through the Setup Role Access matrix found in Review Board Administration.  

Every notification that is sent out by the iRIS system is logged and can be tracked. Since the system automatically generates the notifications, this notification audit tool is very useful for Coordinators who need to check on notifications for other members of their review board or study personnel. All system notifications can be audited here to ensure that they are sent.

Clicking on this icon opens the following Audit Notifications screen with several filters to pull up the notifications you want to see:

Notifications are displayed with fifty items per page. Selections are made using the following filter tools:

Notification Type – Select a notification type from the dropdown list to filter by Notification Type.

Recipient(s) – Use this field if you wish to perform an audit for a specific user in the system that would have received the notification for which you are searching. Only user(s) with entered criteria that have received notifications display.

When the Select User button is clicked, a new screen displays (see below). Enter the search criteria, and click the Find button.  Use the “%” to perform a “wildcard” search.

When you have found your selection, click the Select User icon next to his/her name. Once added to the search filter, you can clear a name by selecting the Clear User button. This tool only allows for reporting of one user at a time; if you happen to select more than one user on a page, only the topmost user is selected and inserted into the search tool.

Select additional filtering from the other fields on the page.

Date Range – If the approximate date of a notification were known, then this would be the best filter.  

IACUC/IRB/IBC Number – This depends on the selection made from the Display Projects by dropdown list.

Subject – Enter a key word or phrase that appears in the subject. Use the “%” to do a “wildcard” search.

Content – Enter a key word or phrase that would appear within the content of the notification. Use the “%” to perform a “wildcard”search.

Provide information for one or all of the search fields to locate the necessary notification, or click Search with no filters entered to return all IACUC notifications in the system. After clicking the Search button, all of the results display in the table under the search engine, with the most recent notification being at the top of the page. You can further sort the notifications displayed in ascending or descending order by clicking in the column headings (as shown below). This feature is not included in the View and Recipient(s) columns.

The following columns populate for your search results: View, Notification Type, IACUC Number (or IBC, depending what you chose to Display Study by), Date Posted, Subject, Recipient(s), and Additional Recipient(s).

Click the View icon to view the actual notification that was sent.  A screen similar to the screenshot below opens, containing information that is read only.

User Management

Grant User Access and Define Roles

This page lists any users who currently have a role on the review board.

Any user who has a role on the IACUC review board populates in this list. The list contains their name, what committee(s) on the board they belong to, what their role is, and if they are a voting member. If their account has the information set up, their Specialty and Affiliation displays as well.

You can change a user’s access by clicking on the icon in the Edit column.

A page listing their contact information as well as their role information opens. You can change their role by selecting another role within a committee. Click on the Save Member Info button if you make any changes before returning to the list.

You can also add a new member to the board if their account has already been created in iRIS. Click on the Add a New Member button. This takes you to a search list of all other users in the database who do not have a role on the board. You can select a user and click on the Save Selected Members button to add them to the board.

Once you choose a user and add them to the board, navigate to that account to setup their specific role on the board, in the same way you would edit the current access of a current board member, as described above.

User Training

The User Training tool allows you to view and set each user’s training record. For additional information aside from what is described here, please see the Sys Admin – User Training - Full manual.

User training can be part of your system’s workflow to check if Key Study Personnel are up-to-date with the review board’s required training or education. If your site does not involve your Training verification in the workflow, it is not required that you enter this information into the system. Contact your system administrator for questions concerning your system’s workflow.

The opening screen initially displays a list of all the study personnel in the system as well as the users associated with your review board. This screen is one of the many methods to view a user’s contact information in the system. The table displays User Name, UIN, Primary Department, Training Group, and Status of the training (Active, Never Active, or Expired), and Override (indicates whether or not the system ignores the user status and treats the user as always “Active”). The icon signifies that the user has at least one active training record on file, which is not expired. The icon represents that there is no valid training record on file. The icon signifies that this user’s training record has expired. Find specific users by adding any known information into the search options at the top of the screen and clicking the Find User button.

To set up the training record for a user, select the Edit/View icon next to the appropriate user or select the Name of the appropriate user. A new page displays (see below). The user’s information displays in read-only format.

The above screen shows the users Training Group Status. Listed on this page are Training Groups associated to the user. Next to each group is a list of courses the user has taken applicable to that group. From this screen you can Edit/View User Training Courses, Reevaluate Training Status, Add a New Training Group, or Delete Training Group(s).

If you click the Edit/View icon next to a Training Group, you are brought to the following screen:

Within this screen, the Group Name is read-only, but you are able to edit the Override Flag or the (Training) Status.

Override Flag – Set this to “Yes” to override any necessary training rules setup for the group for this user only (This feature is applicable for administrator accounts in the system). This means that the system would overlook the user’s current Status when conducting a training status check, so the user would appear as always Active in training and never Expired or Not Active.

(Training) Status – Drop down list contains:

1. Never Active: This means that the training was never set. When a User is created, this is the default setting.
2. Active: This means your training is currently active.
3. Expired: This means your training has passed its expiration date.

If changes are made, click the Save Training Group button and you will return to the previous page.

Clicking the Reevaluate Training Status button revalidates the current user’s training.

To add a new training group, click the Add a New Training Group button, which brings you to the following page (this is the same page you would see if you were to click Edit/View next to a Training Group).

Group Name – Select your desired training group from the drop down list. (This is a configurable list that can be updated from System Administration > List Configuration and Maintenance, under Define Training Groups).

Override Flag – Set this to “Yes,” to override any necessary training rules set up for the group for this user only.

(Training) Status – Select from the drop down list as defined above.

Upon making your selections, click Save Training Group and you will be brought back to the user’s Training Record List.

To delete a training group, check/select the box to the left of the training group you wish to remove from the list and click the Delete Training Group(s) button. By clicking the button at the top of the column in the table, you have the option to select/deselect all groups if needed.

Within the Training record list for the user you have selected, there is a tab for User Training Courses. Click this tab and you will be brought to the following screen displaying a Training Record List with specific courses taken by the user:

This screen displays a table that includes the Course Name, Course Date, Expiration Date, Score, and a Description of the course. By clicking the Edit/View icon to the left of a course, you are brought to the screen below:

This screen displays with the Course Name as read-only. However, you are able to update the Course Date, Expiration Date, Score, Description, Comments, and Delete or Add New Document(s) (e.g. a training certificate). After making any necessary changes, click Save Training Course and Back.

To add a new training course for the selected user, click the Add New Training Course button and you will be brought to the following screen:

Course name – Contains a drop down list of all the courses that are defined in System Administration > List Configuration and Maintenance > Define Training Courses. This is a required field.

Course Date – The date the course was taken.  

Expiration Date – The date that the training course expires. If you do not specify an Expiration Date, the user remains in good standing with the associated Training Group indefinitely.

Score – If you received a score in the training course, record it here.

A Description of the course and Comments can be added as well, if needed.

When finished adding the necessary information, click the Save Training Course button. This causes the document field to display (as shown below).  

Here you can add document(s) associated with the particular training course for you (e.g. training certificate). When you save the course, it will be added to the list of courses within that group for that user.  

To delete a training course, click the checkbox next to the course record, and then click the Delete Training Course(s) button.

The system automatically checks the expiration dates for training courses and automatically updates the status of the course (based on the rules defined for a particular training group setup by the System Administrator).  

User Vaccination History

User Vaccination History is an area where you can go to manage and view Study Personnel and their current vaccination records on file. When a user has a record they would like to track in the system, a review board administrator can come to this page to log their vaccination record into the system.

Listed in this area are current records. A user can have multiple vaccination records, depending on what type of vaccination and when the dates the vaccination was administered, so it is common to see one user listed multiple times.

You can use the filters at the top of the page to locate a particular user, status (Active or Expired), or vaccination type. If you do use the filters, be sure to click the Filter Users button at the top of the page in order for the chosen filters to take effect.

The columns on this page are as follows:

Status – This column displays one of two icons. Theicon indicates that the user has an active vaccine status. The icon indicates that the user’s vaccination record has expired.

Select – If you need to delete a user’s vaccination record, you would first select the record in this column, and then you would click the Delete Vaccination Record button.

Edit/View – To edit or view more details related to the user’s vaccination record, click the icon in this column.

Name – The first name, last name, and any degrees associated to the user display in this column.

User ID – The User ID displays in this column.

Vaccination Name – The Vaccination Name displays in this column.

Administered Date – The date recorded for the vaccination administration displays in this column.

Expiration Date – If the vaccination expires, that date displays in this column.

Auto-Expire Record – When you enter a vaccination record, you can indicate whether or not the vaccination ever expires, and if the system should automatically update the user associated to the record as expired. This information displays in this column.

You can add a new vaccination record to this list by clicking on the Add Vaccination Record button.

A new page opens. You will first need to associate a user to the record. Click the Select User button from the top right corner of the screen.

A Search User Directory page will open. From here use the Last Name and First Name fields to find the user, then click the icon in the Select User column.

You will be returned to the previous page, with the user displayed in the User Selection column.

Complete the rest of the information on the page. Associate the Vaccination Name from the drop down list. Vaccination List is a configurable list within Review Board Administration > List Maintenance Setup > Vaccionation List. Next, indicate the status of the vaccination record. This is typically left as Active, and the system automatically sets the Status to Expired when the Expiration Date passes when Use Automatic Expiration of Vaccination flag is set to “Yes.”

Also enter the Administered Date and the Expiration Date in the provided fields.

Click the Save Vaccination Record button when the necessary information is supplied. Note: You will be unable to save a record until the User Selection is applied to the record.

The record will be added to the list.

If a certain vaccination calls for a series of administration, or to renew an expired vaccination record, you can edit the existing vaccination record and update it with the new administration information. Locate the user and vaccination record and click the icon in the Edit column.

The Vaccination Record List for the user opens. The top of the page displays the user’s information, including contact information. Next, the Vaccination information displays: Vaccination Name, Vaccination Status, and Use Automatic Expiration of Vaccination flag. You can change the status or the override flag, if necessary. If you change this information, be sure to click the Save Vaccination Record button at the top right of the page before exiting.

Below this are any records of vaccination administration. This is reflected with the Administered Date and Expiration Date. Modify this information by clicking the icon in the Edit column.

Records are also deleted by clicking on the checkbox next to the administration record, then clicking on the Delete Vaccination Record(s) button on the top right of the page.

Add a new record by clicking on the Add a New Vaccination Record button.

This allows you to capture an Administered Date and Expiration Date. Click the Save Vaccination Occurance Record button when this information is added.

The Vaccination Record List updates with the new administration record, as well as retains previous administrations. This allows you to keep a running history for this user’s vaccination.

Letter Signoff

Letter Signoff allows you to electronically sign any outcome letters that have been routed to you for approval.

You may be assigned to electronically sign an outcome letter. From your homepage, select Letter Signoff in the IACUC Assistant. Signoff for individual letters can also be accessed through the tasks displayed on the home screen. The screen opens with two tabs: Incomplete and Complete. All submission letters that are awaiting your signature are listed under the incomplete tab.

The submissions in the list are displayed by one of the following: the IACUC Number, IRB Number, IBC Number, or other number (depending on which modules are setup in your instance of iRIS) using the dropdown box in the top right of the screen.  

The Letter Title, Study Title, IACUC Number (or the number chosen to display by), Ref Number, Type, Review Process, Date Letter Created, Continuing Review Due, Expiration Date, PI, and Assigned Analyst of the study submission all display in the table. The list can be filtered by Batched only or Non-Batched only (Batched or non-batched is set when the letter itself is created) by changing the Filter Letters By to the desired option (as shown below).

To review the submissions before signing these letters, select the icon in the Click to open column. The submission processing screens will open. If you are the IACUC Coordinator, then all the tabs display. Otherwise, only the tabs your role has access to display.

You can apply your electronic signature using one of the following two methods:

1. Batch: Review and sign off on all required items at once (the quickest method).

When you are ready to sign off on all the letters select the items’ checkboxes in the first column and click the Sign all selected Letters button. You are then prompted with the alert message below.

Select the OK button to confirm the signoff. The screen displays as shown below.

Apply your iRIS user ID and password (electronic signature) and select the Save button. The screen below displays for a few moments; this screen displays whether or not the letter is already in PDF form or if the letter still has to be routed for signature.

2. Non-Batch Review and signoff item-by-item (longer method).

Select the Edit/View Letter icon and the screen similar to the screen shot below displays.

If you are allowed to change the content of the letter, the contents will appear in Word format; if not, the letter will appear in PDF format.

The submission information (Reference Number, Submission Type, and Approve/Deny) appears on the left side of the screen. You are allowed to add comments to the letter by selecting the Click here to add comments link. A dialog box displays (see below). Enter your comments and click the OK button.

You can approve or deny the letter by selecting the appropriate choice from the dropdown menu. A new field for your electronic signoff appears after you make your selection (see below).

Enter your iRIS User ID and Password (electronic signature) and select the Save Letter Review button. After all the above operations are completed your main Assigned Letter Signoff list will read, “No Letters to Review and signoff.”

The Complete tab displays all the letters for which you have a completed signature. This list can be filtered to a specific date range using the Start and End Date Fields. When the date range is set, click the Refresh page button to update the screen according to the filtered dates.

Reports

The Reports tool allows you access and the ability to run the Pre-canned Reports that come with the IACUC Assistant module. (See the IACUC Assistant -Reports Manual for more information)

The Reports page lists the available reports grouped into a variety of categories. Clicking on a report link allows you to run and set specific parameters for the report. The parameters and filter options for each report will vary based on the requested information.

Within each report you have the option to display the report in PDF, HTML, and Excel format.

When you click the Helpful Information button, the Report Generation Help window populates. The Helpful Information window displays notes that assist you in running the report and displays the description of the report.

Review Board Administration

The Review Board Administration tool allows you to setup configuration lists, define Outcome Letters, define Meeting Agenda and Minutes templates, and setup automatic review board related notifications. Review Board Administration is typically reserved for Review Board Administrators. See the IACUC Assistant – RB Administration manual for more information.