The Conflict of Interest Assistant allows for processing of iRIS™ user conflict matches that have been generated by answers on COI forms. It’s possible to complete many tasks from the Conflict Matches area of the system, including reviewing the match, adding documents, assigning reviewers, and sending out letters and Management Plans. This document covers steps to process Conflict Matches.

Conflict Matches

When a conflict match is found in an annual COI submission, it is routed to the Conflict Matched Objects processing area of the Conflict of Interest Assistant.

This page can be accessed via the Conflict of Interest Assistant > Conflict Matches menu link, or the Conflict Matches icon in the Conflict of Interest Workspace.

The Conflict Matched Objects page lists any conflict match found in any form submitted to the COI Review Board. The COI submission queue is split up into six tabs: Submission Prereview, Not Assigned, Assigned, Completed Matched Objects, Completed Forms, and Agendas.

Submission Prereview

The page initially loads with the Submission Prereview tab open. This tab provides a summary view of conflict matches.

Click the icon in the Open column for a match to open the corresponding submission.

Open Form

When a form is opened from the Open column in the Submission Prereview tab of the Conflict Matched Objects page (see screenshot above), a read-only version of the form opens in the Annual COI Form page (shown below).

The different sections of the form are accessed via the menu tabs at left. By default, this page loads with the General Information tab open.

Covered Person Submission History

A function to view users’ historical COI data is available via the Covered Person Submission History link in the Miscellaneous menu, as shown below.

Clicking the Covered Person Submission History link opens the new Conflict of Interest Submission History page, shown below.

Note that the example shown is from a test user. In common practice most users will not have more than a few line items here.

Notice the items highlighted with black, blue and purple boxes.

A search form is provided at the top of the page (black box in screenshot above), to enable filtering results by COI Form Type, Date Received range or Submission Status.

The results section provides drill down access to view-only information as follows:

Track Location – click this button to view location information for the corresponding line item, including the processing flow node diagram

View Components – click this button to view submission components (documents) for the corresponding line item

Compare Forms – in this column, click to select the checkboxes of form versions to be compared, then click the Compare Forms button in the column header to open the comparison page

View Submission – click this button to view Submission Prereview records, documents and information for the corresponding line item

Show Matches (#) – the number specified indicates the number of matched objects; click this button to view all of the matched objects for the corresponding line item

Interest 1

The Interest 1 column (left hand column in the screenshot above) populates with details of the first conflict match identified by the Covered Person, as follows.

Show Form—where available, click this icon to view the form where the conflict match was identified to open the associated form (Annual COI or Study COI form); where a Print icon is present next to the Show Form icon, click it to view a print-friendly version of the information provided in the List of Match Object(s) for Review section

Covered Person’s Name—name of the person who has indicated a conflict match

Reported Interest Type—type of interest, as noted within the form (e.g., Financial Interest, Financial Commitment, Gifts from a Biomedical Company, etc.)

Reported Interest Third Party—name of the indicated third party interest (the Sponsor with which the user indicated an interest)

Business Status—indicates whether the business is in the database, whether it’s a Sponsor, and whether it’s white- or blacklisted

Reported Role—role indicated by the Covered Person for this conflict match

Reporting Action—where the match originated (e.g., COI Individual Annual Reporting Form, Study COI)

Date Submitted—date the conflict form was submitted into the workflow

Interest Ref Number—reference number of the COI form

Interest 2

This area only populates with information if the Covered Person has a conflict with a certain sponsor, and has a role on a study with that same sponsor. Information about that study populates in the Interest 2 area.

Covered Person’s Name—name of the person who has indicated a conflict match

Reported Interest Type—type of interest, as noted within the form (e.g., Financial Interest, Financial Commitment, Gifts from a Biomedical Company, etc.)

Reported Interest Third Party—name of the indicated third party interest (the Sponsor with which the user indicated an interest)

Reported Role—role indicated by the Covered Person for this conflict match

Reporting Action—where the match originated (e.g., COI Individual Annual Reporting Form, Study COI)

Date Submitted—date the conflict form was submitted into the workflow

Interest Ref Number—reference number of the COI form

Protocol Number—protocol number of the corresponding research study

Study Status—current status of the corresponding research study, where applicable; where inapplicable, the field does not display

View Status Tracking Map

A status tracking map for the submission, including previous rounds, is accessible via the Miscellaneous > Submission History drop down item at the upper left.

Click the Miscellaneous > Submission History to open the Submission History page (shown below).

The page has two tabs: Submissions in Process and Completed Submissions. Click either tab to toggle between them and view either completed submissions or those still in process. The interactive elements on the tabs of this page are the icons in the Track Location column, a link to view the form (Request Type column), and an icon to access Details.

Click the icon in the Track Location column to open the Workflow – Submission Tracking page, where a location tracking map and summary information for the selected form are displayed.

Specific information and page elements shown will vary according to the type of COI form under review, its current processing status, and any customizations made in Review Board Administration settings. For example, the Retract Submission button shown in the screenshot above will not be available for all forms at all stages of match processing.

Click the plus signs at the far left to expand status details for each Task Status section. Alternatively, click any step in the workflow process diagram at top to expand details specific to that step.

In the following screenshot, all available sections have been expanded by clicking the plus signs.

Where a View Signoff button is present, click it to load the Submission Routing Signoff page, which is used to view and print signoff details. Click the Include in PDF Packet checkbox to select items, then click the Printable Version button.

Note that at least one checkbox must be selected in order to print. If multiple items are selected, the option to re-order them in the PDF packet before printing is available.

Where a Retract Submission button is present, click it to retract the submission. A confirmation popup displays, providing the option to either CONFIRM or CANCEL.

Submission Components

Back on the page where a selected form is open (in the example below, it’s an Annual COI Form), the second menu tab is Submission Components. On this tab, details of forms and related documentation that comprise the submission are presented.

Click the Items in List View button at the right to toggle between Items in List View and Items in Folder View. Folder View is only applicable where the submission includes grouped forms and/or documents.

To create a PDF packet, click the checkbox in the Include in PDF Packet column for items to be included, then click the Create PDF Packet button at the right. If multiple items are selected, it will be possible to re-order them before printing the PDF Packet.

View details of a specific item in the list by clicking the plus sign icon in the More Details column for that item. To expand the details section for all items in the list, click the plus sign in the More Details column header.

Use the Print Friendly button to open a simplified list in a new window.

Submission History

Back on the Open Form page, click the Submission History tab to view submission history for the selected open form.

The Status column shows an icon representative of the associated item’s current processing status. A green checkmark indicates the associated item is complete. The circle of fading dots indicates the associated item is still in process.

The View Details column displays an icon for items that have associated forms or related documentation. Where an icon is present, click it to view details of the form or associated documentation.

The Date Received / Date Completed column contains the date received for the item, followed by a forward slash, followed by the date completed for the item. If processing for the item is not yet complete, only a date received and forward slash are shown.

The Event Description column contains a brief description of the item.

Click the plus sign to the left of any item to view Submission Type and Reference Number for that item.

Pre-review Screening

Back on the Open Form page, click the Pre-review Screening tab to enter the results of the screening.

The title of the form, document or object appears in the page header, and its Ref Number appears in red at the upper left of the page.

Status options are as follows:

Not Determined—keep the item in Pre-review Processing and make an entry to the file notating that decision

Proceed with matched objects review—move the item to the Not Assigned tab of the Conflict Matches home page, where its matched objects can be assigned for further review

Review Complete Close all matches—close all matches pertaining to this item and move the item to the Completed Matched Objects tab of the Conflict Matches home screen

Pre-review changes requested—at least one change has been requested, processing cannot continue until the request has been addressed

Process Administratively—opens a special version of the Submission Complete page with a Pre-Review Outcome field; see the Submission Complete section of this manual for more information

Stipulation

Back on the Open Form page, the next tab is Stipulation. There are three ways to add stipulations: Add Multiple, Add New and Add Pre-defined.

Add New Stipulation

Click the Add New button to manually enter a stipulation line item.

The Review Management Strategies page opens. Type or paste in desired text for the stipulation in the provided rich text editor.

Select a Strategy Type and Strategy Category at left, then click the Save the Strategy button to add the strategy to the stipulations list.

There are three Management Strategy Types:

Strategy must be addressed— the covered person must follow the strategy and respond to the COI office with an acknowledgement

Comments that must be addressed— when this type is selected from the drop down list the page refreshes, adding a field to specify a follow-up due date; the Covered Person must respond to the item before the specified date, outside of the main management plan follow-up due date (this is assigned when the management plan is sent to the Covered Person, which is covered later in this manual)

Comments— adds recommendations for the Covered Person; the comments are merged into the Management Plan and require acknowledgement from the Covered Person

Strategy Category — configurable list set up under Review Board Administration; the institution can use this list to categorize strategies as desired

Associate Component(s)

If there are submission components available for the matched object (e.g., COI Study Disclosure Form), an Add Component(s) link is available at the lower left of the text editor page where stipulations are added (red arrow in the screenshot below).

Submission components are associated where possible in order to provide reviewers with a link to the item referenced by a stipulation, to streamline the review process.

Click the Add Component(s) link to associate the applicable component with the stipulation. This opens the Associate Submission Component(s) to your Stipulation page.

Buttons shown on this page vary according to the matched object under review, its available components and stage of processing.

In the screenshot below, the Associate Existing Component button has been clicked. The Associate Submission Component(s) to your Stipulation page opens, listing components available for association.

Click to select the radio button for the item to be associated with the applicable stipulation (red arrow in screenshot above).

Depending on the type of item, one or more drop down lists may appear for specification of a location in the associated submission component (blue arrow in screenshot above). Making a selection in these drop downs, where available, opens the item to the specific section and/or question associated with the stipulation when the reviewer clicks the component link provided with the stipulation.

Click the Return to List button to close the form without saving changes.

Click the Add Link to Selection button to associate the selected submission component. The dialog box updates with details of the component associated with the stipulation.

Click the Done button to confirm the association and return to the Review Management Strategies text editor, where the stipulation remains in draft form.

The left sidebar of the page updates to include details of the associated submission component. Click the red Delete icon in that section to remove the associated component.

Click the Save the Strategy button to save the stipulation.

The Stipulation tab updates with the added stipulation.

Add Multiple Stipulations

Click the Add Multiple button in the Stipulation tab to add multiple stipulations at once.

Copy stipulations that have been formatted as a numbered list in a Word document, then paste the copied, numbered list into the text editor box. Select a Management Strategies Type and Management Strategies Category at left, then click the Save the Management Strategies button to add the pasted list of strategies to the list of stipulations on the Stipulations tab.

Add Pre-defined Stipulations

If certain stipulations are commonly applied, they can be saved to the Pre-defined Strategies list under Review Board Administration > List Maintenance Setup > Predefined Strategies.

Note that this single Strategies list is used for both stipulations and management strategies.

Click the Add Pre-defined button in the Stipulation tab to open a panel listing all available predefined strategies. Select one or more strategies, then click the Save Selected Strategies button.

The stipulation(s) is/are added as a “Strategy must be addressed” type.

All stipulations added, regardless of the method used to add them, appear in the Stipulations to be sent for Response table in the Stipulation tab.

Click the Delete icon next to the applicable stipulation to delete that item.

Click the icon in the Edit column next to the applicable stipulation item to open it for modifications.

Stipulations are displayed in the order added. To reorder them, change the numbering in the Sorting Number column. Change the numbers to re-order the stipulations as desired, then click the Save Stipulation button. Numbering starts at one (1) and continues in descending order (e.g., 2, 3, 4, etc.).

Submission Complete

Back on the Open Form page, click the Submission Complete link to set status to complete for the item currently under review.

The Ref Number for the form, document or object under review is shown in red at the upper left. The top section title reflects the most recent status update on the item. In the example shown below, the title is Returned for Correction. This section contains the following fields:

Review Process—reflects the most recent status of the item

Additional Information required—displays “Yes” if more information is required, “No” if no additional information is required

Submission processing complete—select this box to set processing status to ‘complete’ for the form, document or other object identified by the Ref Number

When the Submission processing complete box is checked a message displays, reminding the user to click the Save the Submission Complete button and describing what will happen to the object next as a result of being marked complete.

Use the Display Submission components status section in the lower half of the form to view, comment on, or package listed items into a PDF.

If there are any grouped items in the list, click the Items in List View button to toggle between List and Folder view.

Click the checkbox next to items to be included in the PDF packet, then click the Create PDF Packet button to generate a PDF Packet of the selected items. Note that if multiple items are selected, there will be an opportunity to re-order them in the PDF Packet.

Click on the name of an item in the Current Submission Components (All Rounds) column to open it for review as read-only. Depending on the item, it may be possible to add comments. After an item is viewed the Submission Complete page updates with the addition of visual and text cues demonstrating the item has been viewed, as well as a Clear Viewed Item(s) button:

In cases where numerous items are listed here, the table makes it easy to see at a glance which items have been viewed, and which have not. Click the Clear Viewed Item(s) button to clear the green highlight bar(s) and You already viewed this item message(s).

Click the More Details plus sign to the right of an item name to view its submission details.

If there are any grouped items in the list, click the Items in List View button to toggle between List and Folder view.

It is also possible to generate outcome letters during the Pre-review screening process of a COI submission form.

As shown above, once a review process has been selected, the user is presented with the Outcome Letter tab allowing them to send a response letter to the covered person and add additional recipients as needed. The templates available are configured in the same area as the outcome letter while processing conflict matches.

Group Matches During COI Prereview (Optional)

A Group COI Match Objects property is available to enable grouping of COI Match Objects during submission Pre Review.

Property Name — rb.use_group_matchobjects_prereview

Property Pathway — [COI Assistant > Review Board Administration > Board Configuration Options > Submission Review Properties]

Default Setting — “No”

When this property is set to “No” the system functions as before and no option to group COI match objects is provided to users.

When this property is set to “Yes” and COI matched objects are identified during submission processing, the users now have the option to group matched objects during “Proceed with matched objects review” processing.

A Group Match Objects checkbox populates on the Submission Complete tab when the Submission processing complete checkbox is selected, as shown in the screenshot below.

When the Group Match Objects checkbox is selected a Create Group button and Add to Group button populate, as shown below. These are the same buttons as those used during review of Conflict Matched Objects, and they function in the same way.

Clicking the Create Group button opens the Create Matched Object Group popup dialog for creation of the new group, as shown below.

Clicking the Add to Group button opens the Add Object(s) to Group popup dialog for selection of the desired group, as shown below.

When the user confirms a group selection in the popup dialog (button is obscured by the drop down list in screenshot above), the applicable matched object is assigned to the selected group.

Not Assigned

Any new match that is unprocessed populates within this tab. There can be multiple conflict matches within each Annual COI form submitted to the Conflict of Interest submission queue. Each match is broken out into its own separate entry within the queue, as opposed to being contained within a single form.

By default, the Not Assigned tab loads with a search form at the top. Use the fields in this form to filter the list of records by Form Name, Match Object Number, Group Name, Covered Person Name, Reported Interest Type, Reported Interest Third Party, Department Name, Keyword Search, Reported Role, Reporting Action, Date Submitted range, Reference Number, Assigned Reviewer or Assigned Analyst.

Click the Close Search link at the upper left to close the search form.

Notice that in the screenshot above, the columns under the blue header labeled Interest 1 are truncated at the right. This is because there are more data elements to display than will fit in a single page. Use the scrollbars at the right and bottom of the form to view the rest of the Interest 1 column and the Interest 2 column (not shown in screenshot).

The columns in the Not Assigned tab are as follows.

—select the checkbox to add matches to a group; see the Grouping Matches section of this manual for more information about grouping matches

Open—click this icon to open a match for processing

Matched Object Number—unique reference number assigned by the iRIS™ system, used to identify the individual match or match group; note that this is not the same reference number used with submission forms in iRIS™.

Group Name—after matches are added to a group, the name of the group displays in this column

Proposal Number — proposal number, where applicable

RB Number — RB number, where applicable

Interest 1

Show Form—where available, click this icon to view the form (Annual COI or the Study COI form ) where the conflict match was identified; where a Print icon populates next to the Show Form icon, click it to view a print-friendly version of the information provided in the List of Match Object(s) for Review section

Form Name — name of the form on which the match is reported

Covered Person’s Name—name of the person who has indicated a conflict match

Reported Interest Type—type of interest, as noted within the form (e.g., Financial Interest, Financial Commitment, Gifts from a Biomedical Company, etc.)

Reported Interest Third Party—name of the indicated third party interest (the Sponsor with which the user indicated an interest)

Reported Role—role indicated by the Covered Person for this conflict match

Reporting Action—where the match originated (e.g., Annual COI Individual Annual Reporting Form, Study COI)

Date Submitted—date the conflict form was submitted into the workflow

Ref Number—reference number of the COI form

Interest 2

Show Form—where available, click this icon to view the form where the conflict match has been identified to open the Annual COI or the Study COI form submitted; there may also be a Print icon next to the Show Form icon, if so, click it to view a print-friendly version of the information provided in the List of Match Object(s) for Review section

Form Name — name of the form on which the match is reported

Covered Person’s Name—name of the person who has indicated a conflict match

Reported Interest Type—type of interest, as noted within the form (e.g., Financial Interest, Financial Commitment, Gifts from a Biomedical Company, etc.)

Reported Interest Third Party—name of the indicated third party interest (the Sponsor with which the user indicated an interest)

Reported Role—role indicated by the Covered Person for this conflict match

Reporting Action—where the match originated (e.g., Annual COI Individual Annual Reporting Form, Study COI)

Date Submitted—date the conflict form was submitted into the workflow

Ref Number—reference number of the COI form

Proposal Number—proposal number of the corresponding research study

Project Status— status of the corresponding project

Protocol Number—protocol number of the corresponding research study

Study Status—status of the corresponding research study (e.g., Draft, Pending – Submitted for Initial Review, Approved, etc.)

Reporting Action PI—Principal Investigator of the corresponding research study

All SSF Comp?—flag to indicate when all Study Specific Forms are complete

All PSF Comp?—flag to indicate when all Project Specific Forms are complete

If the quantity of matches shown is large, a small gear icon appears at the upper right hand of the screen, as shown in the screenshot above. Click the icon to set the number of records to display per screen.

Grouping Matches

Conflict matches that populate in the Conflict of Interest submission queue can be grouped together to be processed as a group on Not Assigned tab, instead of individually. This can be done for any conflict match, but is typically used to group matches for the same Covered Person.

Create Group

To create a Group for future use without adding any matches to it, ensure none of the checkboxes at the far left of the match list are selected and click the Create Group button.

The Create Matched Object Group dialog opens. Enter the desired Group Name and click the OK button to save the Group.

To create a Group and simultaneously add records to it, click the checkboxes next to the records to be added to the Group and click the Create Group button. The Create Matched Object Group dialog opens.

After a Group Name is entered and the OK button is clicked to confirm, the selected items are added to the newly created Group and the Not Assigned tab display updates to reflect the new grouping.

In the example that follows the first two records in the list were selected and the Create Group button was clicked. In the Create Matched Object Group dialog the Group Name “PRE-19-0089 Awarded” was entered and the OK button was clicked.

The Matched Object Number for the first item added to the Group is now the Matched Object Number for the entire Group. Click the yellow folder icon to view the matches within a Group. The items within the Group can now be processed together.

All Groups created via the Create Matched Object Group dialog are added to the Groups list (see Add to Group, next section).

Add to Group

After a Group is created, other matches can be added to it.

Select the checkboxes for records to be added to a Group and click the Add to Group button.

The Add Object(s) to Group dialog displays. Click to select an item in the Select Group drop down list and click the OK button to add the selected matched objects to that Group.

Back on the Not Assigned tab the selected items longer display as individual line items, but are included in the assigned Group.

Note that match items can only be part of one Group at a time. To change the Group assignment for a given item, it must first be removed from its current Group and then added to the desired Group (see next section, Remove from Group).

Remove from Group

If an item was added to a Group by mistake or needs to be moved to a different Group, it is possible to remove the item from its current Group. Once removed, the item can be added to a different Group if desired. Start by clicking to open the yellow folder for the Group, to view all matches within the Group.

Select the applicable checkboxes in the far left column for the record(s) to remove, then click the Remove from Group button.

A confirmation dialog displays. Click Confirm to remove the item from the group.

The matched objects removed from the Group now display as individual line items on the Not Assigned tab. To confirm the item(s) have been removed, click on the applicable Folder icon to open it and verify the removal.

Click Cancel in the confirmation dialog to return to the Not Assigned tab without making any changes.

Correspondence

Depending on their stage of processing, matched objects opened from within the Not Assigned, Assigned or Completed Matched Objects tab of Match Processing may include a Correspondence link in the menu at the left side of the screen.

The Correspondence tab provides access to view, add, reply to, or forward correspondence items attached to the open form or object.

Add a New Correspondence

Click the Add a New Correspondence button at the upper right (shown in screenshot above) to open the Submission Correspondence form (shown in screenshot below). This form is used to process correspondence attached to the selected, open form.

This page includes the following elements:

Send Email— select this checkbox to send the email when it is saved, de-select this checkbox to save the correspondence for archive purposes without emailing it; selected by default

Subject—subject line of the email message

Recipient(s) / Reply To(s) — click these links to open a list containing the names of everyone assigned by the system as eligible to receive Correspondence related to the selected, open form (see screenshot below)

When adding a recipient or reply-to, select the checkbox(es) next to the name(s) to be added to distribution for the message, then click the Save Changes button to return to the Submission Correspondence page.

Additional Recipient(s) / Additional Reply To(s)— to add more email recipients or reply recipients, click on either of these links to open the Correspondence Additional Contacts form (shown below)

Click the Add A New Contact button to add a name and email address to the list. The form populates an editable Name and E-mail Address field, and a Remove Selected Contacts button is added to the form. Add as many additional recipients as desired.

In the example shown below, Add A New Contact was clicked to populate the Name and E-Mail Address fields in the first row. After the desired text was entered in each field, the Add New Contact button was clicked again to add another row, where another Name and E-Mail Address can be entered.

After all desired names and email addresses are added, click the Save and Return button. The names saved here are available for selection as Additional Recipient(s) or Reply To(s) as long as they remain in the list.

If any names are added to the Additional Contacts list in error, click the checkbox(es) next to the name(s) to be removed (area indicated by a yellow box in the screenshot above) and click the Remove Selected Contacts button.

Attachment—click this button to add attachments to the email message

Template—if the system has pre-configured email correspondence templates set up, select the desired email template from the Template drop down list; those with the necessary access rights can also use the Import template button to import new, pre-formatted message templates

Content—rich text editor used to compose the email message; use the icons on the toolbar at the top of the Content area to apply formatting, insert images or links, insert special characters, or print the message

Save & Send Correspondence—click this button to save a copy of the message to the file and where applicable, send a copy to everyone included in the Recipient(s) and Additional Recipient(s) lists; names specified as Reply To(s) or Additional Reply To(s) are included in the list of people who will receive replies to the message

Managing Correspondence

After one or more correspondence items have been created, they are managed on the Correspondence tab.

To open a correspondence item to view it, reply to it or forward it, click on any of the items highlighted by orange boxes in the screenshot above: Forward Email icon (envelope with green arrow), Open icon (notepad with pencil), Post a Reply to this Topic link, or Forward this Topic link.

If the logged in user is the author of an email listed here, AND that email is either still in draft form or has been delivered by the mail system, a Delete icon is available for that email (highlighted by green boxes in the screenshot above).

A Delete icon is provided next to the first email in the list (highlighted with green boxes in the screenshot above) because “Administrator” is the logged-in user (highlighted with a blue box in the screenshot), AND “Administrator” is the author the first email (green box), AND that email has been delivered (see Posted details, second green box).

There is no Delete icon next to the second email authored by “Administrator” (highlighted by a yellow box in the screenshot), because that email has not yet been delivered to all recipients (see Posted details, second yellow box).

There is no Delete icon next to the third email because while Posted details show that the email was delivered, the email author is someone other than “Administrator” (highlighted by red boxes in the prior screenshot).

Note that while deleting an item here removes it from the list, a permanent record of any correspondence that has been sent from within the system will be retained with the associated form or document (item opened from the main Conflict Matches page).

Assigned

After a process is assigned to a Conflict Match, the record moves from the Not Assigned tab to the Assigned tab and can be accessed from this tab until Conflict Match processing is completed.

This page contains the same columns, information, and interactive page elements as the Not Assigned tab, with the exception of the Grouping buttons. On this page the Grouping buttons have been removed and a Print Friendly button appears in the same page location. Click it to view a print friendly version of the matched objects list.

See the Not Assigned section of this manual for more information about page elements and functionality.

Completed Matched Objects

Matches for which processing is complete are listed in the Completed Matched Objects tab. This tab contains the same columns, information, and interactive page elements as the Assigned tab, with one exception: the search panel includes a Review Process (e.g., Expedited, Processed Administratively, etc.) search option.

Items shown in the Review Process drop down list vary according the specific system installation and Review Board Administration settings.

Note that here on the Completed Objects tab, the search form includes a Sort by Date Accessed select box (see screenshot above). Select this box to sort the result set in order by most recently accessed.

See the Assigned section of this manual for more information about page elements and functionality.

Agendas

The Agendas tab opens to the next scheduled meeting of the COI Office and lists any conflict reviews assigned to that meeting date.

There are two categories on the screen: Conflicts assigned to Meeting for full board conflicts and Expedited and Process Administratively assigned to Meeting for items processed Expedited or Administratively which have also been placed on the meeting agenda.

Click the green previous and next arrows on either side of the meeting date at the upper right of the page to select a different meeting date.

The Coordinator can use the Order column to set the order for items to appear on the meeting agenda. Numbering begins with one (1) and continues in descending order (e.g., 2, 3, 4, etc.).

To review a specific match review to be referenced in a meeting, locate the corresponding line item and click the icon in the Open column to open the match review.

Processing Matches

Conflict Matches opened from the Not Assigned Objects tab (shown below) are opened in the Conflict of Interest – Match Review processing pages, which contain information and tools to process a conflict match.

Matched Objects Processing Tabs

A major redesign introduced in v12.01 of iRIS™ introduces new processing queue tabs and revises preexisting tabs as shown in the screenshot below.

Tabs in the redesign are:

Forms Prereview: The Matched Objects page initially loads with the Forms Prereview tab open. All the COI submission forms that are submitted remain within this tab until they are processed. If the submission form is completed or contains no Matched Objects, it moves to Forms Completed. If the user breaks out Matched Objects during the review process, they will appear in the Not Assigned Objects and the form will move to Forms with Pending Objects.

Not Assigned Objects: Any new Matched Objects that are unprocessed will populate within this tab. There can be multiple Matched Objects within each COI form submitted, each of which is broken out into its own separate entry. All the entries remain in the Not Assigned Objects tab until they are assigned a review process.

Assigned Objects: After a review process is assigned to a Matched Object, the record will move from the Not Assigned Objects tab to the Assigned Objects tab and can be accessed from this tab until Conflict Match processing is completed.

Pending Objects: All the Matched Objects that have been completed with an outcome of Management Plan Required and that are still pending response will populate within the Pending Objects tab. Once the matched objects are completed, they will move to the Completed Objects tab.

Completed Objects: Once matched objects are completed, they will move to the Completed Objects tab.

Forms with Pending Objects: All forms associated with matched objects stay within this tab until all matched objects are completed. Once all the matched objects associated to a form are completed, the form moves to the Forms Completed queue.

Form Completed: Once the matched objects are completed, the forms move to the Forms Completed tab.

Agendas: The name and function of this tab remain the same. The Agendas tab opens to the next COI office scheduled meeting and lists any conflict reviews assigned to that meeting date.

Match Summary

The first match processing page is Match Review. Tabs available on the left vary depending on the processing steps required for the specific item under review.

The page opens to the Match Summary tab by default. This tab lists brief details about the match being viewed.

When processing a Group of matches, each match is listed on this page. Scroll down to see each match in detail. Summary details on this page consist of the same information and page elements shown when viewing matched objects from within the Not Assigned, Assigned and Submission Complete tabs.

See the Not Assigned, Assigned or Submission Complete section of this manual for more information about page elements and functionality.

Internal Documents

The Internal Documents tab allows for upload of documents related to the Covered Person and the Conflict Match being processed.

Any documents previously uploaded populate in this page. Click the Add a New Document button to add a document to this review.

Add Documents

When the Add a New Document button is clicked in the Internal Documents tab, an add panel opens for entry of details about the document and for upload of the document file.

Fields presented in the add panel are as follows:

Title—title of the document to be uploaded

Version Number —enter the number at which to start versioning for the document to be uploaded; this can be any character or number

Version Date—Enter or select the date of the manually-entered version number, typically the date the document was uploaded to the system.

Category—use this configurable drop down list to group documents into categories (e.g., Checklist) if desired

Description—enter a brief description of the document to be uploaded.

Load the document into iRIS—after entering the required information, click inside this box or drag the applicable document file into the box to start the upload

Click the Browse button at top right to navigate to the applicable document file, then click the Save selected file button.

The popup closes. The document is uploaded and now appears as an icon next to the document information, as shown in the screenshot below.

Click the Remove link in the Load the document into iRIS box to remove the document.

Click the document icon in the View the document panel at the upper right to view the uploaded file.

Click the Save Changes button to add the document to Internal Documents for the matched object.

Any document record added is appended to the list at the bottom of the Internal Documents page and populates within Search Conflict Matches -> Documents for the Covered Person.

Select the checkboxes next to two different versions of the same document, then click the Compare Document Versions button to compare the two documents.

Click the icon in the Delete column to remove the corresponding item.

To open an uploaded document for revision, click the icon in the Edit column.

Click the icon in the File column to view the document.

Note: Access to Internal Documents is set for each COI Review Board Role within Setup Role Access in Review Board Administration, in the COI Disclosure Document row. The Document Category is set up using the Internal Document Category configuration under Review Board Administration > List Maintenance Setup.

Review Assignment

The Review Assignment tab is where an Analyst is assigned to review the matched object.

Analyst Assignment

The Assign Analyst drop down list is populated with the names of users whose Conflict of Interest role has been set to Coordinator in System Administration.

Select a name from the list to assign an Analyst. When the review assignment is saved, the assigned Analyst received a task on their home page related to this Conflict Match.

Determine Review Process

Use the selections presented here to process the Conflict Match.

Not Assigned — Conflict matches default to this status when first submitted to the Conflict Match queue. This indicates that a Review Process has not yet been assigned and causes the conflict to populate in the Not Assigned tab.

Full Committee Review — This option allows for assignment of the match to a committee meeting. After this option is selected, committee and meeting selection items populate to the right.

The Full Committee Review option can be turned on or off in Review Board Administration settings (see the COI Review Board Administration manual for more details).

Expedite – If this option is selected and saved by clicking the Save the Review Assignment button the page an Assign Reviewers section populates (shown below), provided the reviewer option is turned on for this processing type in Review Board Administration settings (see the COI Review Board Administration manual for more information). After making reviewer selections click the Save the Review Assignment button again.

The Expedite processing option can be turned on or off in Review Board Administration settings (see the COI Review Board Administration manual for more details).

Process Administratively – This option is used for matches that need to be processed through the office but not reviewed.

Selecting Process Administratively and clicking the Save the Review Assignment button populates an Assign Reviewers section, as described above for Expedited processing, if the reviewer option is turned on for this processing type in Review Board Administration settings (see the Review Board Administration manual for more details).

After making and saving any selection other than Not Assigned, or clicking the link to select a past meeting when the Full Committee Review option is selected, four new tab options populate at the left: Review Checklist and Comments, Review Discussion, Meeting Vote and Outcome. These tabs provide easy access to the most commonly used match processing functions and information.

These tabs continue to be accessible when processing this match unless a different review process option is selected and saved.

Assign Reviewers

This option is available for Conflict Matches that have been assigned a review process. This area can be turned completely off in Review Board Administration (see the COI Review Board Administration manual for more details). This section allows the coordinator or administrator to assign a user within the COI Office to review a conflict match.

To add a Reviewer, click the Add Reviewer button in the Assign Reviewers section.

As shown below, the first row of the reviewers table populates with a Delete icon, a drop down Reviewer Role list, and a default Completed? status of “No”.

After any Reviewer Role other than “Ad Hoc” is selected, the page populates a Reviewer drop down list (shown below), containing applicable users assigned to the selected Reviewer Role.

If the Ad Hoc Reviewer Role is selected the page refreshes, allowing for manual entry of the Reviewer name or selection from a Known System identified User list.

After selecting and/or entering the correct data, click the Save the Review Assignment button. The page refreshes with the assigned Reviewer’s information (see below).

As many Reviewers as are needed may be added. Click the Add Reviewer button to add more Reviewers.

To delete a Reviewer, click the Delete icon next to the applicable Reviewer name. A confirmation dialog opens with OK and Cancel buttons. Click OK to confirm the deletion or Cancel to exit without deleting.

Assigned Reviewers receive a notification advising them that a Conflict Match is awaiting their review, and the assignment also appears as a task on the assigned Reviewer’s home page. Notification options are set up under Review Board Administration (see the COI Review Board Administration manual for more details).

If the Review Process is assigned to Review Committee Agenda, the Reviewer does not receive a notification until the Coordinator enables Reviewer notifications for that meeting date.

Reviewer Assignments

When a Reviewer is assigned to a conflict match the Reviewer receives a notification from iRIS™ alerting them to the task. When the Reviewer logs in to iRIS™ the review task is shown in the All Tasks list on the Reviewer’s home page.

The Reviewer task is also added to the Incomplete tab of the Assigned Matched Objects for Review page for the Assigned Reviewers (shown below).

The Reviewer clicks the icon in the Click to open column to review the assigned matched object.

The screenshot above shows the Reviewer Checklist, open to the first section of the conflict match that’s under review.

The Reviewer clicks the Show Form icon in the columns for Interest 1 and Interest 2 (if applicable) to see the actual form submitted by the Covered Person.

The Reviewer clicks the printer icon in the column for Interest 1 to view a print friendly version of the entire form in HTML or PDF format. A dialog pops up, prompting the Reviewer to choose the desired format.

Note that the reviewer checklist form is defined in the System Form Designer and can contain any number of questions for the reviewer to fill out.

After the completing the review of the first section, the Reviewer clicks either the Save Section or Save and Continue to Next Section button.

The Save Section button is applicable in cases where the Checklist or associated Form has been configured to include editable fields for the Reviewer in any sections. The Reviewer clicks Save Section after making a change in a section when the Reviewer does not need to review any other sections.

Otherwise, when review of the active section is complete the Reviewer clicks the Save and Continue to Next Section button.

The Entire view of the Form tab dynamically builds a reviewed copy of the form. When clicked this tab shows a version of the form containing only those sections that have been reviewed and saved, providing an easy way to check progress on the review at a glance.

As the Reviewer progresses through the form, the navigation menu at the left of the form dynamically adds tabs for each section. The Reviewer can click on any section shown in the menu to return to that section.

At the end of the Reviewer Checklist the Reviewer indicates that they are finished with the review and clicks the Save and Continue button. A confirmation message displays. Indicating “Yes” in this section flags the review as complete.

The incomplete Reviewer task is removed from the home page and the Analyst assigned to this conflict match receives a notification and home page task indicating the Reviewer is finished with the review.

Correspondence

The Correspondence tab provides access to view, add, reply to, or forward correspondence items attached to the open form or object.

Add a New Correspondence

This page includes the following elements:

Send Email— select this checkbox to send the email when it is saved, de-select this checkbox to save the correspondence for archive purposes without emailing it; selected by default

Subject—subject line of the email message

Additional Recipient(s) / Additional Reply To(s)— to add more email recipients or reply recipients, click on either of these links to open the Correspondence Additional Contacts form (shown below)

Attachment—click this button to add attachments to the email message

Managing Correspondence

Correspondence items are managed on the Correspondence tab.

Review Checklist and Comments

The Review Checklist and Comments page contains section for Reviewer Check List, Members Check List and Members Comments. Add Member Comments, Add Members Checklist, and Save the Review Status buttons are included at the upper right (see screenshot below).

The Reviewer Check List section lists assigned Reviewers by name and role, and includes links to reviewed objects and documents associated with the respective Reviewer.

If the logged in user is the assigned Reviewer, they can click the applicable icon in the View/Edit column to open the checklist for editing. The Reviewer can status their review as complete by changing the “Yes/No” value in the Completed? column and clicking the Save the Review Status button.

The Members Check List section lists the names of Board Members who have added their own Members Checklist to the matched object.

The Members Comments section displays comments added to the file by Board Members.

Board Members and Analysts can create a Members Checklist by clicking on the Add Members Checklist button at the top right of the page.

This opens a Member checklist, which is the same form the Reviewer filled out. The Board Member or Analyst can answer the same questions but does not have to indicate completion because this is not a Reviewer task. Rather, the Board Member or Analyst is adding a checklist as supplemental documentation. When the form is finished and the Board Member or Analyst returns to the Review Checklist and Comments page, the Members Check List table populates with an entry as shown below.

The Board Member or Analyst can access their checklist by clicking on the applicable Edit icon, or delete the checklist by clicking the applicable delete icon [ ]. Only the Board Member or Analyst who added the Members Checklist can delete it.

Board Members can add comments to the conflict match by clicking on the Add Member Comments button. The Member Comments page opens, enabling the Board Member to add comments in a rich text editor.

Two checkboxes are provided above the text editor (red arrows in screenshot above) to control comment and Board Member name visibility. Both are selected by default, meaning that both the comments and the name of the person who entered them are visible to the full board.

If the Board Member wishes to keep their comments hidden from other Board Members, the Display my comments on the review checkbox should be deselected

If the Board Member wishes to post their comments for other Board Members to see, but wishes to keep their comments anonymous, the Display my name with the comments checkbox should be deselected

Click the Save the comments button to save changes and return to the Reviewer Checklist and Comments page.

Recall that the Board Member comment is shown only if Display my comments on the review was selected at the time the comment was saved, and the Board Member name is shown only if Display my name with the comments was selected at the time the comment was saved.

If the comments are flagged as anonymous or hidden by de-selecting those checkboxes at the time the comment was saved, only the user who added the comments can see their name and/or the comments displayed on this screen.

Review Discussion

The Review Discussion tab can be used to capture information related to the match review. These can be notes from the Analyst or any discussion about the conflict that take place during a meeting. Items from the Reviewer Checklist can also be merged into the Review Discussion. The Review Discussion can then be merged into letters and meeting minutes.

To add information to the Review Discussion, click the Edit Submission Discussion button.

The Conflict of Interest – specific discussion page opens. Type or copy and paste the desired text into the rich text editor. Click the Save button to save the entered text and close the page.

The text is displayed in the Review Discussion table. Click the Edit Submission Discussion button to add to the discussion, if needed.

Meeting Vote

This tab only populates for the match review the Full Committee Review type is selected.

This tab is used to capture votes for the match review. The vote can be recorded at the time of the meeting or any time afterward, but before match review processing is complete. Start by clicking the Add Motion button.

The Submission Motion page opens with a rich text editor for entry of the motion. Motion text can be typed or copied and pasted into the text editor.

To use a precanned motion, select a template from the Precanned Motion text drop down list and click the Add Canned Language button. Precanned language for use in these motions is configured under Review Board Administration > System Setup > Setup Canned Motion.

Click the Save Changes button to save the motion and close the page. The motion text appears at the top of the Meeting Vote section (shown below). Click the delete icon [ ] to delete the added motion text. Click the edit icon (pad and pencil) to revise the added motion text.

Depending on the review board configuration, the motion may or may not be set for anonymous voting. If anonymous voting (vote summary) is specified, the page appears similar to the screenshot below.

Enter the number of members who voted for each Vote Type in the Number text field corresponding to each Vote Type. After entering the votes, click the Save the Vote Summary button.

The Anonymous Voting option is toggled off or on under Review Board Administration. For more details on this setting, please refer to the COI Assistant - Properties manual.

If Anonymous Voting is toggled off in the system, attendance must be set before voting can take place. If attendance has not been set, the Meeting Vote panel shown below displays.

Attendance is taken under Conflict of Interest Assistant > Meeting Management > Meeting Manager. There, the responsible Coordinator or Board Member selects the current meeting and marks attendance.

After attendance is entered, the list of members present displays as shown in the screenshot below.

The vote type is selected in the Vote column next to each Member Name. Columns are provided to display each member’s Gender, Specialty, Relationship to the Institution, Affiliation, Representational Capacity, and Representative of Specific Entity information can also be found under the corresponding columns, as provided in the member’s user profile.

A Comments line is provided to enter any comment the member wishes to have notated with their vote.

After the votes for the motions are set click the Save the Members Vote button. The votes are saved and can be merged into outcome letters.

Click the Add Motion button to add more motions to the Meeting Vote.

Outcome

The Outcome tab, typically reserved for COI Coordinators, is where an outcome is set for the match review. Here, the Coordinator can select items from a reviewer checklist and merge them into management strategies or pull the information into outcome/response letters or meeting minutes.

After reviews are complete for a conflict match the Outcome tab includes a summary page of all Reviewer Checklists and member checklists.

Select the desired outcome from the Review Outcome drop down list at the top of the page. The outcomes in the list are configured under Review Board Administration > List Maintenance Setup tab > Review Outcome/Outcome Configuration List. The outcome selected from this drop down list indicates whether the conflict match is acceptable to the COI Office as-is, or if a management strategy must be put in place.

If any Review Outcome other than “–none–“ or “Approved with Conditions” is selected the page refreshes and three additional tabs are added to the menu at left: Internal Routing, Outcome Letter and Outcome Sent.

If a Review Outcome of Approved with Conditions is selected the page refreshes, and four additional tabs are added to the menu at left: Management Strategies, Internal Routing, Management Plan & Outcome Letter and Outcome Sent.

Note: The label shown on the Outcome Letter tab depends on the outcome selected. Where a Management Plan is required the label reads Management Plan & Outcome Letter. Otherwise it reads Outcome Letter.

An opportunity to define any management strategies before sending the management plan to the Covered Person is provided.

Note: The Covered Person receives a task on their home page regarding the management plan; see the COI Assistant – For Covered Persons manual for additional details on how this process functions from their side.

In the Reviewer Checklist Summary table a list populates, containing the questions from the checklist and the names of Reviewers and Board Members who completed the checklist. The answers to questions from the checklist appear beneath the Reviewer/Board Member names.

To the left of the Reviewer/Board Member name are three checkboxes that can be used to merge the corresponding Reviewer/member’s answer into the desired location, as follows.

— a checkmark in the first column merges the item into the Review Discussion tab when the Merge Comments into Review Discussion button is clicked (shown previously in full screenshot of the Outcome tab, buttons are at the upper right), minus the reviewer/member name

Anything that is merged into the discussion can be pulled into the meeting minutes via use of the Submission Specific Discussion merge code in the meeting minutes template.

— a checkmark in the second column merges the item into an Outcome Letter when it is generated, provided the Submission Review Summary merge code is used in the outcome letter template

— A checkmark in the third column converts the answer to the question into a Management Strategy on the Management Strategies tab when the Merge Comments into Management Strategies button is clicked (shown previously in full screenshot of the Outcome tab, buttons are at the upper right)

After setting the outcome and merging the desired items in the checklists, click the Save the Submission Outcome button (shown previously in full screenshot of the Outcome tab, buttons are at the upper right).

COI Matched Objects Returned for Corrections

A Review Outcome of “Return Form for Corrections” is available on the Outcome tab of the Match Review processing area. With this outcome it is possible to add stipulations on a COI form matched object at the pre-review stage, up until such time as a review process is assigned to the matched object.

When the “Return Form for Corrections” outcome is selected and the submission is saved, Stipulation and Outcome Letter tabs are unlocked in the left hand sidebar. The user can now send stipulations associated with the submission form from which the matched object was generated to the applicable covered person (see Stipulations Tab section, below). Note that stipulations can only be applied to an individual matched object, or to two or more matched objects that are grouped together for processing.

Recall that stipulations can only be applied up until such time as a review process is assigned to at least one matched object on the form. If one of the matched object(s) has been assigned a review process, a warning message popup displays to advise the user that one or more matched objects have been assigned a review process and the “Return Form for Corrections” outcome is not available.

After the warning message closes the user must choose a different Review Outcome to proceed.

Stipulations Tab

The Stipulations tab functions the same as in the Study side (IRB), allowing the user to send the covered person stipulations linked to the form. Stipulations and responses from any previous submission are also displayed here.

Just as when adding a stipulation on the study side, a text editor is provided for entry of stipulations and association to specific sections of the submission form.

Note that the user can also comment directly on a question on the form; in that case the comment automatically populates in the Stipulations tab.

Management Strategies

If the Covered Person associated with the conflict match needs to adhere to a Management Plan, the Management Strategies tab populates in the menu. From this page, it is possible to create the strategies to be merged into the Management Plan. Each strategy is added to the list as a separate line item.

There are four ways to populate the page with management strategies.

1. Strategies merged from the Outcome tab. The screenshot above shows strategies that were merged in from the Outcome tab.

2. Add Multiple Strategies – Click this button to add multiple strategies at once.

Copy strategies that have been formatted as a numbered list in a Word document, then paste the copied, numbered list into the text editor box. Select a Management Strategies Type and Management Strategies Category at left, then click the Save the Management Strategies button to add the pasted list of strategies to the Management Strategies list.

There are three Management Strategy Types:

Strategy must be addressed— the covered person must follow the strategy and respond to the COI office with an acknowledgement

Comments that must be addressed— when this item is selected from the drop down list the page refreshes, adding a field to specify a follow-up due date; the Covered Person must respond to the item before the specified date, outside of the main management plan follow-up due date (this is assigned when the management plan is sent to the Covered Person, see the Outcome Letter section of this manual)

Comments— adds recommendations for the Covered Person; these comments are merged into the Management Plan and require acknowledgement from the Covered Person

3. Add a New Strategy – click this button to manually enter a strategy line item

When this button is clicked a new page opens, allowing for entry of management strategy text in a rich text editor. Select a Strategy Type and Strategy Category at left, then click the Save the Strategy button to add the strategy to the Management Strategies list.

4. Add Pre-defined Strategies – if certain strategies are commonly applied, they can be saved to the Pre-defined Strategies list under Review Board Administration > List Maintenance Setup > Predefined Strategies.

When the Add Pre-defined Strategies button is clicked, a page listing all the predefined management strategies opens. Select a strategy or multiple strategies, then click the Save Selected Strategies button. The strategy is added as a “Strategy must be addressed” type.

All strategies added, regardless of the method used to add them, appear in the Management Strategies table.

Click the Delete icon next to the appropriate strategy record to delete that strategy item.

Click the icon in the Edit column next to the appropriate strategy record to open the strategy item for modifications.

Strategies are displayed in the order added. To reorder them, change the numbering in the Sorting Number column to specify sort order, then click the Save Strategies button.

Internal Routing

The Internal Routing tab within a submission is a very useful tool for COI Analysts, who can use this tab to route the conflict match internally, any number of times, all at once. Internal Routing can be used to show a Chairperson a specific match review or to have a specialty reviewer view the conflict match.

The Internal Routing tab allows for routing notes on the match. Click the Assignment notes link to add these notes.

The Assignment Notes are added to the Internal Routing page and are included when Submission items are routed.

This page is used to create the list of users whose reviews are needed to complete an internal signoff on the Conflict Match.

Click the Add Review Board Routing button to add Review Board members. This creates a row allowing for selection of a Board Member from a drop down list (red arrow in screenshot below), and to optionally set a Role for the Board Member (blue arrow in screenshot below). Click the Save Routing List button to save changes.

To enter reviewer-specific assignment notes (optional), click the Assignment Comments button above the user’s name.

A text editor opens. Enter desired comments and click the Apply button to save changes and return to the Internal Routing tab. Click the Cancel button to close the text editor and return to the Internal Routing tab without adding comments.

The entered comments populate to the right of the Assignment Comments link. These comments are specific to the user and populate in the assignment when the user opens their task.

Click the Add Non-Review Board Routing button to add someone who is not a Review Board member to Internal Routing. The Search User Directory page opens, allowing for look up by Last Name, First Name, Department, or any combination of all three.

Click either the Save Selected User(s) button or the Select User icon (green checkmark in the Select User column) to add an individual person to Internal Routing.

If the search has returned multiple users to be added to Internal Routing, select the checkbox in the Check for Multiple column next to each name to be included, then click the Save Selected User(s) button to add the names and return to the Internal Routing tab.

Each name added populates in a separate row and has the same Assignment Comments button available to add comments specific to each person.

Routing occurs in the order indicated by the numbers entered in the Order Number column, with the lowest number (zero) being first in the routing order. One (1) is next, followed by two (2), and so on.

When the user with the lowest order number completes the assigned routing, the next user in the order on the list is notified for signoff. This process continues until the list is completed. Users with the same order number receive the notification at the same time.

The list can be re-ordered by changing the numbers in the Order Number column. If a user who has already been notified is subsequently deleted, the user with the next highest order number is notified. This keeps the submission moving in the event a user does not sign off in a timely manner.

Beneath the assignment notes display there is a Yes/No question (red arrow in screenshot below): Have you completed your selection of required routings? The default answer selection is “No”.

When changes to the routing list are complete, click to select the “Yes” radio button and click the Save Routing List button.

Internal Routing Task

When a user has been notified of an Internal Submission Routing Signoff assignment, upon logging into iRIS™ they will find an Internal Submission Routing Signoff task on their COI Workspace home screen.

To complete their review, the user clicks the icon in the Click to Open column to open a Review validation page.

The page includes sections for Match Object(s) under review, Assigned Reviewers, Management Plan Document details (if applicable), Response Letter details (if applicable), and Outcome. Only the first section is shown in the screenshot below.

After completing their review of each applicable section and object, the user scrolls down to the Internal Submission Routing block at the bottom of the form.

From this area, the user can indicate whether they are finished with the review.

The user can add more routing tasks, if needed, by clicking the Add Routing button.

The user can remove a routing task by selecting the checkbox to the left of the routing item and clicking the Remove Routing button.

If the user needs to comment back to the Analyst, they can click on the User Comments button to open the text editor.

Any user comments added are reflected in the User Comments area of Submission Routing, as shown below (red arrow).

Before the task can be removed from the user’s home screen, the user must indicate “Yes” in the Complete box, enter their login credentials (if required) and click on the Save Routing button.

When all users assigned to the Internal Routing have completed their routing assignments, the Analyst for the match review receives a notification from the system as well as a home page task. When the task is opened, the Analyst is returned to the Internal Routing tab.

From here the Analyst can see when the users completed their assignments and if they have included any comments. The Analyst can also use the Add Review Board Routing or Add Non-Review Board Routing buttons to add more routing tasks.

Outcome Letter

This tab allows the Analyst to create a Management Plan and/or an Outcome Letter to send to the Covered Person or other individuals as needed. Depending on the outcome assigned, the tab may read Management Plan & Outcome Letter or just Outcome Letter.

This page is broken up into two parts, Management Plan Document and Response Letter.

The Management Plan Document can be created to pull in the Management Strategies added earlier.

To create the Management Plan, begin by selecting a template from the Select a Plan Template drop down list in the Management Plan Document area. After the template is selected, click the Create Management Plan button.

Management plan templates are created under Review Board Administration > System Setup > Setup Management Plan. There is no limit to the number of templates that can be defined.

After the Create Management Plan button is clicked, a text editor page is displayed. The text editor contains an editable version of the management plan.

When changes in the text editor are complete, click the Save Management Plan Changes button. When the plan is saved, the Check In/Out tab populates with Download Document and Upload Document buttons the Analyst can use to complete editing of the plan offline, then upload a revised version to the system later.

To the left of the text editor page is the match information (Reference Number and Assigned Analyst). To require signature signoffs for this letter, select “Yes” under Does this plan require signature signoffs? When this is done, another field populates as shown below:

Batch signoff allows a user to sign more than one letter at a time. If this is applicable, select “Yes.”

If the signature signoff was set to “Yes,” the user is redirected to the Submission Plan Signoff Routing List page when the Save Management Plan Changes button is clicked.

There are two ways to add a user to approve and signoff on the letter: via the Add Review Board Signoff button or the Add Non-Review Board Signoff button.

When clicked, the Add Review Board Signoff button adds a row to the signoff block enabling the user to choose any COI Board member.

When clicked, the Add Non-Review Board Signoff button opens the Search User Directory form, enabling the Analyst to choose any user in the iRIS™ database and add their name for signoff, regardless of Board member status.

Selecting a user from the list in the search form and clicking the Save Selected User button adds a row to the signoff block with the selected user’s name.

After selecting the users required to sign off, their records appear as shown in the screenshot below.

Order Number — specifies who receives the signoff task first; users with the same order number receive the task at the same time

Name — name of the user (selected from the drop down menu) who must sign the outcome letter

Signoff — if the logged in user is assigned this signoff task, the writing hand icon next to the user’s name darkens ()and the user can sign off on the letter by clicking this icon

Approved — status of the letter after the user has approved or denied it

Include Signature — if this field is set to “Yes,” the user’s electronic signature is required when they approve the letter

Allow Change — if this field is set to “Yes,” the user designated for signoff is allowed to edit the letter

Date Received — date that the user receives the letter for signature

Date Completed — date that the user applies their electronic signature

Comments —comments the user may have entered upon sign off

To delete a user previously added to the signoff block, click to select the checkbox next to the applicable name, then click the Delete Selected Signoff(s) button.

Once all selections are made, click “Yes” in the Have you completed your selection of required signatures? field and click the Save Signoff List button. A notification is sent to the first user selected for signoff.

Navigating back to the Outcome Letter tab, the newly-created Management Plan is added to the list.

Other Outcome Letters can be added in a similar fashion. The Send button is dimmed until routing signoff is complete. In the example shown above signoff is complete so the Send button is lit and accessible.

A letter can be deleted by clicking the icon in the Delete column for that letter. Additionally, the letter can be routed for further signoff by clicking the Route Signoff icon.

A letter can also be copied. When a letter is copied it defaults to require no signatures for signoff, so any desired routing must be manually added. In addition, the Send button is lit and accessible for the copy and its status is set to Waiting to be Sent.

It is possible to generate an Outcome Letter using the drop down menu in the Response Letter area of the Outcome Letter tab. The templates available in the Select a Letter Template drop down list are configured within Review Board Administration > System Setup > Setup Outcome Letter Templates.

Outcome Letters are generated the same way that the Management Plan Document is created and can also be routed for signatures.

Management Plans and letters are sent from the Outcome Letter tab (shown above), or they can be bundled with Management Strategies (where applicable) to be sent to the Covered Person.

Note: If the Management Plan Document and Outcome Letter are sent from the Outcome Letter tab it will not be possible to include them in the bundle, this is an either-or selection.

Outcome Sent

Once the review process for a conflict match is complete, navigate to the Outcome Sent tab to send the Management Plan and any other letters to the Covered Person along with any Management Strategies.

The Outcome selected on the Outcome Letter tab displays in the Outcome section at the top of the page.

If the Outcome does not require a management plan no Follow-up Due date field appears in the Outcome section, as shown in the previous screenshot.

If the Outcome requires a management plan a Follow-up Due date field is added to the Outcome section, as shown below.

The Review process summary table section is next, beneath the Outcome section. If this is the first round of review for the conflict match, this table is blank. Later, if a match needs to be reviewed again after a response to management strategies is received, this table populates with information from the previous round of review.

The Personnel to Receive Notification section is next, beneath the Review process summary section. Here, it is possible to specify a user or users to receive the management plan or outcome letter. The system auto-populates the Covered Person and flags them as “Response Required” if the outcome is to send a Management Plan. If the outcome is approved, the Covered Person defaults as the primary recipient.

Click the Add Personnel button to add more recipients for the Management Plan Letter and/or Outcome Letter. The Search User Directory page opens, enabling user lookup and selection. Search and find the user, then click the Select User icon (green checkmark in the Select User column).

Back on the Outcome Sent tab, the user is added to the table of Personnel to Receive Notification section.

More than one user can be selected to receive the letter when saving the Outcome Sent tab, but a response is only required from one user. This means that the system creates a task on that user’s home page allowing them to respond to the management plan. Any other user listed here receives a notification from the system, but not a task. It is typical to indicate that the response is required of the Covered Person.

Remove a user from the table by clicking the corresponding Delete icon for the user in the far left column.

Any Management Plan documents created in the Outcome Letter tab populate in the Management Plan Document area. Click the Attach to Response E-Mail checkbox next to the document to include it in the response.

Any Response Letters created in the Outcome Letter tab populate in the Response Letter area. Click the Attach to Response E-Mail checkbox next to the document to include it in the response.

If the Management Plan or Outcome Letter has been sent from the Management Plan / Outcome Letter tab it is no longer possible to attach the item to the response being sent back to the Covered Person.

The last section on the Outcome Sent tab is Email Notification. Select a template from the Email notification template drop down list.

The templates in this drop down list are configurable and are set up under Review Board Administration > Review Board Notification Setup > Response Notifications. There is no limit to the number of templates that can be added, but only one can be selected to generate a response message for each match.

After selecting a template from the list, click the Generate Response Message button. The rich text editor opens, containing the contents of the selected template. This template can contain merge codes to pull in information related to the specific match being processed.

The text pulled in with the template can be modified as desired in the text editor.

When changes (if any) to the notification are complete, click the Save the Response Message button at the upper right of the page. The response can now be completed back in the Outcome section at the top of the Outcome Sent tab.

A confirmation prompt message dialog appears, as shown below.

Click OK to send the response. Click Cancel to return to the Outcome Sent tab without sending the response.

The system attaches any Management Strategies and the Outcome Letter to the email template generated by the system. The email is sent to anyone selected in the Personnel to Receive Notification table. The conflict match is then locked against further edits.

If a Management Plan is listed as required in the applicable Outcome tab, a new Management Plan Response tab populates beneath the Outcome Sent tab (see the Management Plan Response section of this manual).

If the conflict match is approved, the pages are set to read-only and the review is complete in the system.

Note: In some cases, it is possible to undo the completion of the conflict match: if the match is assigned to a full board review and the meeting minutes for that meeting date have not been finalized, or if the conflict match has been processed as Expedited or as Administratively Processed, it is possible to deselect the Conflict Processing complete checkbox. Setting the match back to an editable state should only be used when absolutely necessary, because the applicable letters and response message is again bundled and sent to selected recipients when the checkbox is again marked as complete.

Management Plan Response

When the Covered Person has replied to the Management Plan Response, the assigned Analyst receives a Conflict Response Complete task on their home screen.

Opening this task opens the Management Plan Response tab for the conflict match.

This page summarizes the response from the Covered Person in the Management Response table. Any Management Strategies are listed, along with the Covered Person’s response to each strategy and any details provided.

After reviewing the Covered Person’s response, it is possible to specify how to further process the match review in the Conflict Resolution section (shown in screenshot above). If the response from the Covered Person is satisfactory, select the first radio button, “Yes it can be closed.” If more time is needed to review the response, leave the selection for “No still in progress” in place. If further processing is needed for the conflict match, select the “No must be reviewed again” option. After a selection is made, click the Process Response from COI Response button to complete processing.

If a status of “Yes it can be closed” is selected for the match, the system closes out processing for this match review. No further action is necessary.

If a status of “No still in progress” is selected for the match, processing remains in the Management Plan Response tab until status for the match item is updated.

If a status of “No must be reviewed again” is selected for the match, the system reopens the match for a new round of reviews in the Match Summary tab of a new review round (shown in screenshot below).

Alternatively, the match review can be looked up by Reference Number in the Assigned tab of the Document Management dashboard.

When a match review is opened, it loads in the Match Summary tab.

At the top of the page in the example above, the Review Round Number reads “2”, meaning this is the second round of review for this Conflict Match.

The match review processing can continue as needed via the Review Assignment tab by assigning a review process and reviewers if needed.

In that case, processing continues from here as with the first round of review.

Upload Evidence to Management Plan Response Task / View from Board Side

Covered persons can now view a Form Name associated with the COI task the user has been sent by the COI Analyst at the top of the page under Matched Object Number/Group Name, and a Show Form button has been added to provide the Covered Person with access to the original form screen associated with the task.

Also, a new upload document table has been added to the Management Plan Response page to enable the Covered Person to upload evidence of a conflict response when applicable.

Documents uploaded by the covered person display as a read only table when viewed by the COI Analyst, enabling the Analyst to view evidence documents while processing responses.

If the COI Office/analyst sends a response to a user’s COI submission, the user receives a task on their home page under the Respond to Conflict Management Plan group as shown in the screenshot below.

Clicking on the task opens the Management Plan Response page, which lists Management Plan Document(s) (including any Outcome Letter generated) and Management Strategies.

When the Covered Person has replied to the Management Plan Response, the assigned Analyst receives a Conflict Response Complete task on their home screen. Opening this task opens the Management Plan Response tab for the conflict match (shown in screenshot below).

The screen above summarizes the response from the Covered Person in the Management Response table. Any Management Strategies are listed, along with how the Covered Person responded to each strategy and any details provided.

After reviewing the Covered Person's response, the Analyst can specify how to further process the match review in the Conflict Resolution table depending on the response of the Covered person.

After the right selection has been made, the Analyst clicks the Process Response from COI Response button.

If the status of the conflict is closed, the system closes processing for the match review.

COI Management Plan Follow Up

Management Plan Follow Up

Beginning with iRIS™ version 12.01 it is possible to configure the system to automatically send a Management Plan Follow-up Task/Form to a Covered Person a specified number of days after a Matched Object is closed under the Management Plan Response link.

A “Management Plan Follow-up” form type has been created to be generated by the system the specified number of days after the Matched Object is closed. The Management Plan Follow-up Form includes access to the original management plan(s), response(s), and any applicable outcome letter(s).

When the user selects the "Yes it can be closed” radio button under the Conflict Resolution box within the Management Plan Response link, a new show/hide logic field appears under the Status Conflict field called “Send Management Plan Follow-up Task/Form” (shown in screenshot below).

When “Yes” is selected for Send Management Plan Follow-up Task/Form, a new field populates beneath it (shown in screenshot below) to indicate the number of days after the matched object is closed to send the Management Plan Follow-up Form. The field pre-populates from the number of days configured in the COI Follow-up Report notification type (under RBA > Notifications > Conflict of Interest Follow-up Report Notifications Setup link), but allows the user to override the number of days if desired. See the COI – Notifications manual for more information about the new COI Follow-up Report notification.

When the nightly thread runs it identifies Matched Objects closed the specified number of days from the current date. If “Yes” was selected for Send Management Plan Follow-up Task/Form on a given item, either a Task/Form is sent to the Covered Person (shown in screenshot below) OR a Follow-up Form/Task date populates in the database the specified number of days from date closed when the status of the Matched Object is closed and saved.

When “Yes” is selected for “Send Management Plan Follow-up Task/Form” and the Process Response from COI Response option is also selected, the system automatically sends the Covered Person a Conflict of Interest Follow-up Report Notification and subsequent reminders (where applicable) in the number of days specified in the COI Follow-up Report notification / reminder.

After a Management Plan Follow-up Task/Form is submitted, it can be attached to the original Matched Object that triggered it. When the user responds to a Management Plan by selecting the “Yes it can be closed” option and also selects “Yes” for the Send Management Plan Follow-up Task/Form” option, a new Management Plan Follow-up Task/Form link populates under the Management Plan Response link. A Response Letter can be added and sent to the Covered Person, as well as additional recipients, under the Management Plan Follow-up Task/Form link.

Conflict Matches

Submission Prereview

Open Form

Covered Person Submission History

Interest 1

Interest 2

View Status Tracking Map

Submission Components

Submission History

Pre-review Screening

Stipulation

Add New Stipulation

Associate Component(s)

Add Multiple Stipulations

Add Pre-defined Stipulations

Submission Complete

Group Matches During COI Prereview (Optional)

Not Assigned

Interest 1

Interest 2

Grouping Matches

Create Group

Add to Group

Remove from Group

Correspondence

Add a New Correspondence

Managing Correspondence

Assigned

Completed Matched Objects

Agendas

Processing Matches

Matched Objects Processing Tabs

Match Summary

Internal Documents

Add Documents

Review Assignment

Analyst Assignment

Determine Review Process

Assign Reviewers

Reviewer Assignments

Correspondence

Add a New Correspondence

Managing Correspondence

Review Checklist and Comments

Review Discussion

Meeting Vote

Outcome

COI Matched Objects Returned for Corrections

Stipulations Tab

Management Strategies

Internal Routing

Internal Routing Task

Outcome Letter

Outcome Sent

Management Plan Response

Upload Evidence to Management Plan Response Task / View from Board Side

Management Plan Follow Up

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