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

The Conflict of Interest Assistant will allow you to process conflict matches for iRIS users that have been generated by answers on COI forms. From the Conflict Matches area of the system, you can complete many tasks including reviewing the match, adding documents, assigning reviewers, and sending out letters and Management Plans. This document will review the steps to process Conflict Matches.

Conflict Matches

Once an Annual COI form is submitted and a conflict match is found, it will be received by the Conflict of Interest Assistant within the Conflict Matches menu item.

The Conflict of Interest – Conflict Matched Objects page will list out any match found in any form submitted to the COI Review Board. The COI submission queue is split up into four tabs: Not Assigned, Assigned, Completed and Agendas. When you open the Conflict Matches page, the default tab is the Not Assigned tab.

Not Assigned

Any new match that is unprocessed, will populate 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 up into its own separate entry within the queue, as opposed to being contained within a single form. The columns listed in the Not Assigned tab are as follows.

- Use the checkbox to select matches and add them to a group. Conflict Match Groups will be discussed in more detail below.

Open – Click this icon to open a match for processing.

Matched Object Number – Each conflict match in iRIS will be assigned its own unique reference number used to identify this individual match. Note that this is not the same reference number used with submission forms in iRIS.

Group Name – After adding matches to a group, the name of the group will display in this column.

Interest 1

Show Form – Click on this icon to view the form where the conflict match has been identified. This will open the Annual COI or the Study COI form submitted.

Covered Person’s Name – Displays the name of the person who has indicated a conflict match.

Reported Interest Type – Depending on the specific issue, this column will populate with the type of interest, as noted within the form. It could be a Financial Interest, a Financial Commitment, Gifts from a Biomedical Company, etc.

Reported Interest Third Party – This column will populate with the indicated third party interest (the sponsor the user indicated the interest with).

Reported Role – This column will populate with the role indicated by the Covered Person for this particular conflict match.

Reporting Action – This column will display where the match has come from – whether the Annual COI (Individual Annual Reporting Form) or from a Study COI.

Date Submitted – The date the conflict form was submitted into the workflow.

Ref Number – This is the column that will populate with the reference number of the COI form.

Interest 2

This area will only populate with information if the specific conflict match has a matching study to display. If the Covered Person has a conflict with a certain sponsor, and also has a role on a study with that same sponsor, information related to the study will populate in the Interest 2 area.

Show Form – Click on this icon to view the form where the conflict match has been identified. This will open the Research Application.

Covered Person’s Name – Displays the Institution Name of the study’s primary Department.

Reported Interest Type – Depending on the specific issue, this column will populate with the type of interest, as noted within the form. It could be a Financial Interest, a Financial Commitment, Gifts from a Biomedical Company, etc.

Reported Interest Third Party – This column will populate with the indicated third party interest.

Reported Role – This column will populate with the study role indicated by the Covered Person for this particular conflict match.

Reporting Action – This column will display where the match was found. This will typically be the Study Application.

Date Submitted – The date the Reporting Action was submitted into the workflow.

Interest Ref number – This is the column will populate with the reference number of the Reporting Action.

Protocol Number – The Protocol Number of the corresponding research study.

Study Status - The Study Status of the corresponding research study.

Reporting Action PI - The Principal Investigator of the corresponding research study.

Creating Groups

Conflict matches that populate in the Conflict of Interest submission queue can be grouped together where they can be processed as one item instead of processing the matches individually. This can be done for any conflict match, but is typically used to group matches for the same Covered Person.

Create Group

Begin by clicking the checkboxes next to the records to add to the group. Then, click on the Create Group button.

This will cause the screen to gray out and provides a box that will allow you to type in a Group Name. Click Save to create this group and add the selected matches to the group. Click Cancel to back out of the group creation.

When you save the group, the page will refresh and you will receive a message from the system that the group has been saved.

After a few moments, the page will return to normal and the group you added will display at the top of the Not Assigned queue. The Group Name column will populate with the group name you specified. The Matched Object Number column will populate with a link. When you first create a group, you need to open the group record so the system can generate a grouped Matched Object Number.

After clicking the link and returning to the Not Assigned tab, the newly generated Matched Object Number will populate and will be used to reference the entire group of matches.

You can view the matches within the group by clicking on the yellow folder icon. The items within this group can now be processed together.

Add to Group

After you create a group, you can add other matches to it.

First click on the records of matches that are not already associated to a group. Then click on the Add to Group button. Note: You cannot add items already associated with another group. You would first need to remove that item, and then add it to the new group.

This will cause the screen to gray out, and provides a box that will allow you to select an existing group from a drop down list. Click Save to add the selected matches to the group. Click Cancel to back out.

When you save the group, the page will refresh, and you will receive a message from the system that the selected items have been added to the group.

Remove from Group

If an item was added to a group by mistake, you can remove that item from the group.

Start by opening the yellow folder to expand the matches within the group. Select the record(s) to remove and then click on the Remove from Group button.

This will cause the screen to gray out and provides a box that will allow you to confirm the removal from the group. Click Confirm to continue to remove the item from the group. Click Cancel to back out.

When you confirm the removal, the page will refresh, you will receive a message from the system that the selected items have been removed from the group.

Assigned

After assigning a process to a new Conflict Match, the record will move from the Not Assigned tab to the Assigned tab and can be accessed from this tab until the Conflict Match is completed.

This page lists any processed matches, and contains the same columns and information as the Conflict Matches described in the Not Assigned section of this document.

Completed

The Completed tab will contain a link to previously processed and completed Conflict Matches. When you open this tab, it will display a search tool and any previously completed matches. You can use the search tool to narrow down a list of results to find the completed Conflict Match you are looking for.

The search tool contains a list of processes available to search by. Expedited and Processed Administratively are the two available search processes for Conflict Matches. You can select a process, and then indicate a time frame of when the match was completed by entering dates in the Submission Completed from and to date fields. Click the Refresh button to refresh the page with any resulting Conflict Matches. You can then open the items.

Agendas

The Agendas tab will open to the next upcoming meeting for the COI Office. This page will list out any conflict reviews assigned to this meeting date. There will be two categories on the page, Conflicts assigned to the Meeting (these are full board conflicts) and Expedited and Process Administratively assigned to Meeting (these are any items processed Expedited or Administratively and also placed on the meeting).

You can flip between meeting dates by clicking the green arrows next to the meeting date.

If you are looking for a particular match review on the meeting, you can locate it and then open it by clicking on the icon in the Open column.

Processing Matches

When you open a Conflict Match from the Not Assigned tab, you will open the Conflict of Interest – Match Review processing pages. These pages will present you with information and tools to process a conflict match. Depending on the way the match is processed, you may or may not see certain tabs (on the left side menu).

Match Summary

The first tab in the Match Review of the Conflict Match lists brief details about the match being viewed. If you are processing a group of matches, each match will be listed on this page and you can scroll down to see each match in detail. The summary details on this page consist of the same information listed in the Not Assigned, Assigned and Completed tabs. From this tab, you can see the details of the match and open the COI Annual form for viewing.

In addition, there is a Covered Person’s History section on the Match Summary tab. This table provides information about the covered person’s prior conflict matches.

Internal Documents

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

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

A new page will open. Here you will specify the name of the document, in the Title field.

Version Number - Requires you to specify what number you wish to start the version number with. This can be any character or number.

Version Date – This is the date of the manually-entered version number. This is typically the date the document was uploaded to the system.

Category – This configurable dropdown list allows you to group documents into certain categories.

Description – A description of the document.

Enter the required information, and then click the Upload button to upload the document.

A small window will open, allowing you to upload a document. You will need to browse for the document on your computer, by clicking on the Browse button. This will open another window allowing you to navigate the folders on your computer so you can locate your document. Once you have associated a document, click the Save selected file button.

The system will return you to the previous page. The document will be uploaded to the study, and it will appear as an icon next to the document information, as shown above. Click the Save Changes button to create the record.

Any document record you add will be displayed on the page.

Note: Documents added here will populate within Search Conflict Matches -> Documents for the Covered Person.

Documents can be compared to other uploaded documents. Click the checkboxes next to two documents, and then click the Compare Document Versions button.

Any uploaded document can be removed by clicking the icon in the Delete column.

To edit an uploaded document, click the icon in the Edit column.

You can view the document by clicking on the icon in the File column.

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

Review Assignment

The next tab, Review Assignment, allows you to process the conflict match.

Analyst Assignment 

You can choose a person within the COI office who is responsible for processing this conflict match. To populate this dropdown list, a user must be assigned as a Coordinator when assigning their Conflict of Interest role in their user account under System Administration. An analyst will receive a task on their homepage related to this Conflict Match.

Determine Review Process 

Use the selections presented here to process the Conflict Match.

Not Assigned - The Conflict Match will default to this status when it is 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.

Assign to Review Committee Agenda – This option allows you to assign the match to a meeting. After this option is selected, the committee and meeting selections will be displayed. (See below).

This option can be turned on or off in your review board configurations (see the Review Board Administration manual for more details). After selecting this option, five new tab options will be displayed: Correspondence, Review Checklist and Comments, Review Discussion, Meeting Vote, and Outcome.

Expedite – If this option is selected, the screen will refresh with the option of selecting a reviewer(s) once you have clicked the Save the Review Assignment button. Once you have finished with your selections on this page, click the Save the Review Assignment button again. The new tabs will become available for your conflict match as described above. This option can also be turned on/off in your review board configurations.

Process Administratively – This process is a useful action for matches that need to be processed through the office but not reviewed. Selecting this Review Process and clicking the Save the Review Assignment button will also allow the coordinator to select reviewers for the match, if the reviewer option is turned on.  The Correspondence, Review Checklist and Comments, Review Discussion, and Outcome tabs will be displayed after you select this Review Process.

Assign Reviewers

This option will be available on Conflict Matches that have been assigned a review process.  This area can be turned completely off in Review Board Administration.  This section allows the coordinator or administrator to assign a user within the COI Office to review a conflict match.

To add a reviewer, select the Add Reviewer button.

The screen will refresh, allowing you to select from a list of reviewer roles that are pre-defined under Review Board Administration.  After the role (a non-Ad Hoc role) is selected, the screen will refresh to allow you to select from a dropdown list of reviewers.

If an Ad Hoc reviewer is selected, the screen will refresh, allowing you to manually enter the reviewer’s name or select it from a list of users.

After selecting and/or entering the correct data, select the Save the Review Assignment button.  The screen will refresh with the reviewer’s information (see below).

You may add as many reviewers as needed.  A reviewer can also be deleted from the list simply by selecting the red X icon next to the appropriate reviewer.  A confirmation will be displayed to confirm the removal.  Select the OK button to proceed or the Cancel button to cancel the process.

After the reviewers are selected, they will receive a notification advising them that a Conflict Match is waiting for their review.  This notification can be set up under Review Board Administration.  The Review Assignment will also appear as a task on their home screen.

If the Review Process is assigned to Review Committee Agenda, the reviewer will not receive a notification until the coordinator enables the reviewer notifications for that particular meeting date.

Reviewer Assignments                    

When you assign a reviewer to a conflict match, the reviewer will get a notification from iRIS to let them know of the task.

When the reviewer logs in to iRIS, there will be a task in the Conflict of Interest Reviewer Assignment group.

When the group is expanded, a reviewer task with details about the conflict match will populate. The reviewer can click the Open icon to start a reviewer checklist form.

The reviewer checklist form is defined in the System Form Designer, and can contain any number of questions for the reviewer to fill out. One data value used in the reviewer checklist form is a value that will link to the conflict matches the reviewer is looking at. The screenshot above shows the reviewer checklist with the conflict match being reviewed. The reviewer can click on the Show Form icon to see the actual form submitted by the Covered Person.

As the reviewer progresses through the form, navigation will build on the left of the form, allowing the reviewer to jump back and forth between sections.

At the end of the reviewer checklist, the reviewer will indicate that they are completed with the review and click the Save and Continue button. Indicating “Yes” in this section will flag the review as complete.

The incomplete reviewer task will be removed from the home screen and the analyst assigned to this conflict match will receive a notification and home screen task indicating the reviewer is finished with the review.

Correspondence

This tab allows you to communicate with other COI Officers or covered persons. This section will also allow you to send correspondence to an email address outside of iRIS. When you first access the area to add correspondence, the screen will look like this:

The page will list all correspondences associated with the match review, if any have been created.  To add correspondence, select the Add a New Correspondence button.  

Send E-mail: This checkbox is checked by default, meaning that the correspondence will also be sent to the specified recipients via email (if available). The correspondence will send to the email provided in the user’s account. Whether or not this box is checked, this correspondence will be available under My Assistant > View Correspondence.

Subject: This field determines what will show up in the subject field of the correspondence.

Recipient(s): Choose from a list that displays the Covered Person, Key Study Personnel (only if the Conflict Match is related to a research study in iRIS), and members on the Review Board or the COI Office. To select the individual(s), check the box(es) next to the name(s). To select all the listed Personnel, select the icon above the checkboxes. Select the Save Changes button when finished.

Additional Recipient(s):  This is used to add persons to the list of recipients that are not users in iRIS.

Select the Add A New Contact button.

Enter the Name and a valid E-mail Address for the recipient. You can add as many additional recipients as needed. If you need to remove a contact, click the checkbox next to the contact, and then click the Remove Selected Contacts button. Click the Save and Return button to return to the correspondence page.

Reply To(s)/Additional Reply To(s): Add users here if you would like them included in any replies to the correspondence outside of iRIS. The Reply To(s) link allows you to select from the same set of users as when you were originally selecting recipients. The Additional Reply To(s) link allows you to enter names and e-mail addresses of non-iRIS users. Any user added here will receive an email to their outside email when another person replies to this correspondence thread outside of iRIS.

Attachments: If there is a document you would like to add to the correspondence, click the Add Attachment button.

You will be required to enter the title of the attachment. The actual attachment can be uploaded by clicking the Upload button. You will then be prompted for the file’s location.

If the location is unknown, select the browse button to use your window browser to browse through your system files. After the file is located, select the Save selected file button to upload the file or the Cancel button to cancel the process. After the document is uploaded, an icon will display next to the Title. To replace this document with another one, select the Upload button again. Select the Save And Return button. The attachment will appear in your notification. You will be able to delete the attachment(s) or add more attachment(s) as necessary.

Import Template: Within Review Board Administration, correspondence templates can be set up. These templates can then be imported into the correspondence by selecting the desired template from the dropdown list and clicking the Import Template button.

Content: Use the text editor provided here to enter the content of your correspondence.

After you have entered the necessary information for the correspondence, select the Save & Send Correspondence button.  Once the correspondence has been saved and sent, the information regarding the correspondence will display in a table (see the screen shot below). You may add a reply to the correspondence by clicking the Post a Reply to this Topic link, or you can click the Forward this Topic link to forward the message to a recipient. This would also be sent in the same manner as explained above. You may also view the content of the correspondence by clicking on the View Message Icon.

Review Checklist and Comments

Review Checklist and Comments will list out reviewer assignments with access to the reviewer checklist. This is also an area where board members can create a member checklist and add comments to the conflict match.

The page will first list any reviewer checklists.

If you are logged in as the reviewer, you will be able to edit the checklist by clicking on the icon in the View/Edit column. You can also status your review as complete by changing the “Yes/No” value in the Completed? column. If you are not the reviewer, you will be able to view the reviewer checklist.

The Review Checklist and Comments page is an area of the match review that other board members can access prior to a meeting. They will be able to review any reviewer checklists and they can fill out their own checklist, if needed. They can also leave comments for other board members and analysts to review.

As a board member or analyst, create a member checklist by clicking on the Add Member Checklist button at the top right of the page.

This will open a member checklist, which is the same form the reviewer filled out. The board member can answer the same questions but will not have to indicate completion, as this is not a reviewer task, but simply a form they are filling out.

When the form is finished, and the board member returns to the Review Checklist and Comments page, the Members Check List table populates with an entry. The member can access their checklist by clicking on the Edit icon. Delete the checklist by clicking the icon corresponding to the record.

Board Members can add additional comments to the conflict match by clicking on the Add Member Comments button.

A new page will open, allowing the board member to add comments in a rich text editor. Above the text editor are two checkboxes, both are selected by default. If the member wishes to keep the 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, but wants to keep the comments anonymous, the Display my name with the comments checkbox should be deselected. Once comments are entered, click the Save the comments button to save the comments and return to the Reviewer Checklist and Comments page.

If the comments had been flagged as anonymous or hidden, only the user who added the comments would see their name and/or the comments displayed on this page.

Review Discussion

The Review Discussion 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 in turn be merged into letters and meeting minutes.

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

A new page will open, containing a rich text editor where you can type in or copy and paste your information. When you are finished, click on the OK button.

Your text will be displayed in the Review Discussion table. You can click the Edit Submission Discussion button to add to the discussion, if needed.

Meeting Vote

This tab will only populate for your match review if you placed the match onto a full board meeting.

Use this tab to capture votes for the match review. You can capture the vote at the time of the meeting, or any time afterwards, but before you complete the match review processing. Start by clicking the Add Motion button.

A new page will open with a text editor where you can type in or copy and paste a motion. You can also use precanned motions by selecting a template from the Precanned Motion text dropdown list; then, click the Add Canned Language button. The precanned language for the motions can be set up in Review Board Administration > System Setup > Setup Canned Motion.

Once your motion is defined in the text editor, click on the Save Changes button.

Depending on your review board configuration, the motion you added may or may not be set for anonymous voting.  For more details on setting this configuration, please refer to the COI Assistant - Properties manual.

If it is anonymous voting (vote summary), then the screen will appear similar to the screenshot below.  

Enter the number of members that voted for a particular vote type in the Number text field. After entering the votes, be sure to click the Save the Vote Summary button.

If the anonymous voting is off, the added motion will appear as shown below.

Attendance will need to be set before voting can take place. If attendance has not been set, the above screen shot will be displayed. If attendance has been set and taken, the list of members present will be displayed (see example below).

The vote type can be selected in the Vote column next to each Member Name. 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.

After the votes for the motions have been set, select the Save the Vote Summary/Save the Members Vote button. The votes will be saved and can be used to merge into outcome letters (see the COI Assistant – Administration Manual for more information).

Outcome

The Outcome tab allows you to specify an outcome for the match review. After reviews are complete for a conflict match, you will be able to see a summary page of all reviewer checklists and member checklists on this page as well. This page is typically reserved for COI Coordinators. From the Outcome tab, you can select certain items from a reviewer checklist and merge them into management strategies or pull the information into outcome/response letters or meeting minutes.

When you are ready to set the outcome for the review, select the outcome from the Review Outcome dropdown list at the top of the page. The outcomes in the list are configurable and can be set up under Review Board Administration > List Maintenance Setup > Review Outcome/Outcome Configuration List. The outcome you select from this dropdown list will determine the path of the conflict match, whether the conflict is acceptable to the COI Office or if a management strategy needs to be put in place.

You can also make a selection from the Disclosure Status dropdown list, which is configured under Review Board Administration > List Maintenance Setup > Configure Disclosure Status.

If you select an outcome of Approved, or another outcome that does not require further action, the page will refresh, and you will have three additional tabs to the left that you can visit: Internal Routing, Outcome Letter and Outcome Sent.

If you select a review outcome that indicates a need for a management plan, an additional tab will populate for Management Strategies. You will be able to define any management strategies before sending the management plan to the Covered Person.

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

The Outcome tab also lists a summary of any reviewer and member checklists completed for this match review.

In the Reviewer Checklist Summary table, a list will populate containing the questions from the checklist, and, under that the names of reviewers and board members who completed the checklist. The answers to the questions from the checklist appear underneath the reviewer/board member names.

To the left of the reviewer/member name are three checkboxes that can be used to merge that reviewer/member’s answer into a certain place in the system.

- The first column will merge the item into the Review Discussion tab. When this is checked next to a question and the Merge Comments into Review Discussion button is clicked, this question will be merged into the Review Discussion, minus the reviewer/member name. Anything that is merged into the discussion can be pulled into the meeting minutes, provided the Submission Specific Discussion merge code is used in the meeting minutes template (more is discussed on setting up the minutes later).

- The second column will merge the item into an Outcome Letter when it is generated, provided the Submission Review Summary merge code is used in the outcome letter template.

- The third column will take the answer to the question and create a management strategy on the Management Strategies tab. When this is checked next to a question and the Merge Comments into Management Strategies button is clicked, the system will create a management strategy using the answer to the question as the management strategy.

At the bottom of the Outcome tab is the Office of General Counsel Outcome dropdown menu. You can select an Outcome from the values in the list, which are configured under Review Board Administration > List Maintenance Setup > Office of General Counsel Outcome List.

After setting the outcome and merging the desired items in the checklists, click the Save the Submission Outcome button.

Management Strategies

If the Covered Person associated with the conflict match needs to adhere to a management plan and the outcome set in the Outcome tab is one that indicates a management plan is required, this tab will populate in the menu. From this page, you can create the strategies that you want to merge into your management plan.

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

1. The strategy can be merged in from the Outcome tab. The screenshot above shows a strategy that was merged in using the merge tool in the Outcome tab.

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

This is a tool used generally when you have a list of strategies in a Word document. You can copy and paste the strategies into the editor provided, select a Management Strategies Type, and then click Save the Management Strategies to add all strategies at once.

Each strategy will be created as its own separate record.

3. Add a New Strategy – Click to add one strategy at a time.

When you click this button, a new page will open, allowing you to type in or copy and paste the text for the management strategy in a rich text editor. To the left of the editor is a dropdown list allowing you to specify the type for the strategy. There are three types:

Strategy must be addressed – A frequently-used type for many strategies. This means you need the covered person to follow the strategy and respond to the COI office with an acknowledgement.

Comments that must be addressed – When you select this type from the dropdown list, the page will refresh, allowing you to specify a separate follow-up due date. This simply means you need the Covered Person to respond to the item before a certain date, outside of the main management plan follow-up due date (this is assigned when you are sending the management plan to the Covered Person, which is covered later in this document).

Comments – Use this type when you want to simply leave recommendations to the Covered Person. The comments would be wrapped up into the management plan and would still need an acknowledgement back from the Covered Person.

4. Add Pre-defined Strategies – If you have a list of commonly used strategies, you can define a list under Review Board Administration > List Maintenance Setup > Predefined Strategies.

When you click the Add Pre-defined Strategies button, a page listing all the predefined management strategies will open. You can select a strategy or multiple strategies, and then click the Save Selected Strategies button.

The strategy will be added as a “Strategy must be addressed” type.

Once you have your strategies defined, they will all appear in the Management Strategies table.

You can delete a strategy by clicking the red X icon next to the appropriate strategy record.

Any strategy can be modified after it is created or merged in. Click the icon in the Edit column to open the strategy for modifications.

Strategies are displayed in the order you added them. If you would like to reorder them, you can change the numbering in the Sorting Number column. Change the numbers, and then click the Save Strategies button.

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

Internal Routing

The Internal Submission 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 contains a table that first lets you define any notes to pass on to anyone you select for routing. Click the Assignment notes link to add these notes.

Underneath the assignment notes is a Yes/No selection. This defaults to No. After you select the routing, make sure you set the selection to Yes and then click the Save Routing List button.

The Analyst can compile a list of users needed to complete an internal signoff on the Conflict Match.  Review Board Members can be added by clicking the Add Review Board Routing button.  This will create a row that allows you to choose from a dropdown list of board members on the Review Board.

Non-Review Board members can be added by clicking the Add Non-Review Board Routing button.  A new page will open, allowing you to use the Search User Directory screen, where a user can be searched and added to the routing.

Before completing the list of users to receive the routing task, you can assign reviewer-specific assignment notes to each user. Click the Assignment Comments link above the user’s name.

A text editor will open, allowing you to type in or copy and paste your comments. Click the Apply button after adding your comments, or click Cancel to proceed without adding comments.

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

When the list is compiled and completed, select “Yes” in the Have you completed your selection of required routings? field and click the Save Routing List button. This will cause an email notification to be sent (if this notification is configured under Review Board Administration) to the user with the smallest order number in the list. If the list is not marked as Complete in the Internal Submission Routing tab and Saved, the email notification will not be sent. When the user with the lowest order number completes the assigned routing, the next user in the order on the list will be notified for signoff. This process will continue until the list is completed.  Users with the same order number will receive the notification at the same time.

Additionally, if you delete a user that has already been notified, the user with the next order number will be notified.  This allows you to keep the submission moving in the event a user does not sign off in a timely manner.  

Internal Routing Task

When a user is notified of an Internal Routing Signoff assignment and they log into iRIS, there will be a home screen task under the Internal Submission Routing Signoff group. Expand the group and click the icon in the Open column.

This will open a Review Validation page. The page will list out the Match Object(s) under review, list the Assigned Reviewers and give you the ability to view their checklists, show Outcome Letters generated for the review, display Outcome information, and finally, at the end of the page, the Internal Submission Routing information.

The user would review each of these items, and then scroll to the bottom of the page to finish the review.

From this area, the user can indicate whether they are finished with the review. They can also add additional routings, if needed, or remove another routing task.

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

Before the task can be removed from the user’s home page, the user must indicate “Yes” in the Completed? column and click on the Save Routing button.

When all users assigned to the Internal Routing have completed their routing assignments, the analyst of the match review will receive a notification from the system as well as a home page task. When the task is opened, you will be returned to the Internal Routing tab.

From here you can see when the users completed their assignments and if they have left any comments. You will also be able to add another user to the routing, if needed.

Management Plan and Outcome Letter

This tab will allow you to create a Management Plan or an Outcome Letter to send to the Covered Person or other individuals as needed.

Note: If the Conflict Match is not being returned for a Management Plan, this tab will read “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 dropdown list in the Management Plan Document area. After the template is selected, click the Create Management Plan button.

The management plan templates are created under Review Board Administration > System Setup > Setup Management Plan. You can have as many templates defined as needed.

After clicking the create button, a screen will be displayed with a text editor. The text editor will contain the modifiable version of the management plan.

Note: If you are using a browser other than IE, you will need to use the download and upload button that will be available when you Edit/View the letter or sign off on it. The reason for this is that the plug-in implemented in the browser is not available in Firefox and Safari and other browsers. Thus, our software will adjust to these issues by giving you the option of downloading and uploading the letter when necessary.

To the left of the screen 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 will populate as shown below:

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

Make changes to the content of the letter as necessary. You may also insert templates by selecting the Insert Template Language button. First, place your cursor in the letter where you would like the template language to appear, and then click the button.

A list of template language will appear. Template Language is pre-defined under Review Board Administration > System Setup > Setup Template Language. To select the template, click on the icon next to it. The window will now display the template language, as seen below.

Copy and paste the text into the notification letter, or click the Insert Template Language button. After all necessary revisions/additions are made, select the Save Management Plan Changes button.

If the signature signoff was set to “Yes,” you will be redirected to the Submission Plan Signoff Routing List page when the save button is clicked (see below).

There are two ways to add a user to approve and signoff on the letter:

1. Add Review Board Signoff – This allows you to choose from any COI board member.

2. Add Non-Review Board Signoff – This allows you to choose any user in the iRIS database, regardless of their access to the COI Office.

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

Order Number – Specifies who will receive the signoff task first. Users with the same order number will both receive the task at the same time.

Name – This is the name of the user (selected from the drop down menu) who must sign the outcome letter.

Signoff – This column is only useful for the currently logged-in user. An icon will populate in this column for each user.  If you are looking at this page and have been selected as the signoff personnel, the icon next to your name will darken and you will be able to sign off on the letter by selecting this icon.

Approved – This area will display the 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 will be required when they approve the letter.

Allow Change – If this is set to “Yes,” the user designated for signoff will be allowed to edit the letter.

Date Received – This is the date that the user receives the letter for signature.

Date Completed – This is the date that the user applies their electronic signature.

Comments – Any comments the user may have entered upon sig off.

Delete Selected Signoff(s) – Delete users selected for signoff by checking the box next to their name and clicking this button.

Once all selections are made, click “Yes” in the Have you completed your selection of required signatures? field. This will send a notification to the first user selected for signoff. Navigating back to the Management Plan & Outcome Letters screen, you will see the Management Plan that you just created in the list. Other outcome letters can be added in a similar fashion. If the selection of required signatures has been completed, then the Send button will be useable. The letter can be deleted by selecting the icon in the Delete column. Additionally, the letter can be routed for further signoff by clicking the Route Signoff icon. It can also be copied.

When a letter is copied, it is set by default to require no signatures for signoff, and the routing must be set up. In addition to this, the send button will be useable and the status will read Waiting to be Sent.

You can also generate an Outcome Letter using the dropdown menu in the Response Letter part of the Management Plan and Outcome Letter tab. The templates available in the Select a Letter Template dropdown list are configured within Review Board Administration > System Setup > Setup Outcome Letter Templates.

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

You can send the Management Plans and letters created on this page, or you can also choose to bundle these items when you send the Management Strategies to the Covered Person in the next tab. Note: If you send the Management Plan Document and Outcome Letter from this page, you will not be able to include them in the bundle.

Outcome Sent

Once you have completed the review process for the conflict match, you will need to send the Management Plan and any other letters to the Covered Person along with any Management Strategies.

In the Outcome table at the top of the page, the outcome you selected on the Outcome tab will display. If you chose an outcome that would require a management plan, you will be able to indicate a Follow-up Due date. If the outcome does not require a management plan, the Follow-up Due date field will not populate on this page.

Under the Outcome table is the Review process summary table. If this is the first round for the conflict match, this table will not populate with any information. Later, if you determine it needs to be reviewed again after a response to management strategies is received. this table will populate with information from the previous round.

The Personnel to Receive Notification table allows you to specify a user or users who will receive the management plan or outcome letter. The system will auto-populate the Covered Person and flag them as “Response Required” if the outcome is to send a Management Plan. If the outcome is approved, the Covered Person will default as the primary recipient.

You can have additional recipients listed; these users will also receive a copy of the Management Plan Letter and/or Outcome Letter. Click the Add Personnel button.

A new page will open, allowing you to search the iRIS database for a user to add. Search and find the user, and then click the Select User icon.

The user will be added to the table. You can select more than one user to receive the letter when you save the Outcome Sent tab, but you only indicate that a response is required from one user. This means that the system will create a task on the user’s homepage allowing them to respond to the management plan. Any other user listed here will receive a notification from the system, but not a task. You would typically indicate that the response is required of the Covered Person.

You can remove a user from the table by clicking the red X icon.

Any Management Plan Documents created in the Management Plan and Outcome Letters tab will populate in the Management Plan Documents area. You will need to click the checkbox next to the document to include it in the response.

The Response Letter table will populate with any Outcome Letters you have generated. You will need to click the checkbox next to the letter to include it in the response.

If you have already sent the Management Plan or Outcome Letter from the Management Plan and Outcome Letter tab you will not be able to attach it to the response back to the Covered Person.

The last table on the page is the Email Notification table. Before you can generate a response to the Covered Person, you need to select a template from the Email notification template dropdown list and click the Generate Response Message button.

The templates in this dropdown list are configurable and are setup under Review Board Administration > Review Board Notification Setup > Response Notifications. You can have any number of templates available, but you are able to select and generate only one for each match.

After generating the template, the rich text editor will populate containing the content of the template. This template can contain merge codes that will pull in information related to the specific match you are processing. You will be able to modify the content by typing into the text editor.

Once you generate the Response Message, you will have the ability to save the response or complete it. To save your work, click the Save the Response Message button. Once you have selected all required information and included the necessary letters to the response, you can complete the process by clicking the Conflict processing complete checkbox.

Completing the processing will cause a message prompt. You will need to indicate OK to proceed with sending the response. Click Cancel to back out of sending the response.

Once you click OK, the system will bundle up any Management Strategies and the Outcome Letter and affix them to the email template you generated. The email will be sent to anyone you selected in the Personnel to Receive Notification table.

The conflict match will become locked and you will no longer be able to edit it. If you indicated that a management plan is required in the Outcome tab, a new tab, Management Plan Response, will populate underneath the Outcome Sent tab (more is described below). If the conflict match is approved, the screens will still become read-only and the review is complete in iRIS.

Note: In some cases, you will be able 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 Expedited or Administratively Processed, you will be able to uncheck the Conflict Processing complete checkbox. Setting the match back to an editable state should only be used for certain cases, as when you complete the process, the letters and response message will bundle to the selected recipients again.

Management Plan Response

Once the Covered Person responds to the Management Plan Response, the Assigned Analyst will receive a home page task in the Conflict of Interest Analyst Assignment – Conflict Response Complete Group.

Opening this task will bring you to the Management Plan Response tab for the conflict match.

This page will summarize the response from the Covered Person in the Management Response table. Any Management Strategies will be listed out, along with how the Covered Person responded to each strategy and any details provided.

After reviewing the Covered Person’s response, you can specify how to further process the match review. Specify this process in the Conflict Resolution table. If the response from the Covered Person is satisfactory, select the first radio button, “Yes it can be closed.” If you need more time to review the response, leave the selection for “No still in progress”. If you need to further process the conflict match, select the “No must be reviewed again” selection. After you make your selection, you must click the Process Response from COI Response button.

If you status the conflict to be closed, the system will close out the processing for this match review. No further action is necessary.

If you leave the status to still in progress, the processing will stay with the Management Plan Response tab until you status the conflict differently.

If you indicate that the status must be reviewed again, the system will reopen a new round for the conflict match. The system will direct you to the Match Summary tab of a new review round, or you will be able to find the match review on the Assigned Tab by looking up the Reference Number.

When you open the match review, it will open back to the Match Summary tab. At the top of the page, the Review Round Number reads 2, meaning this is the second round of review for this Conflict Match. You will be able to further process the match review as needed by going to the Review Assignment tab and assigning a review process and reviewers if needed.