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

IRB Assistant will allow you to process new study applications and oversee existing studies. You can review the study, informed consents, and any other study related documents. Through the Submissions area of the Study Assistant, you can process new submissions, assign reviewers, conduct meetings, send out minutes, and letters based on the review outcome. This document will review the steps to process submissions and will detail how to assign reviewers and manage studies.

Submissions

Once a new study is submitted, it will be received by the IRB Assistant within the Submissions menu item.

Your build of iRIS™ may display either Submissions or Committee Submissions in the IRB Assistant list, depending on how your system is setup (Review Board property “rb.use_submission_by committee”. See the IRB Assistant –Properties Manual for more information).

This feature allows you to view and process all submissions sent to the review board.

When you click on the Submissions or Committee Submissions link, a page will open displaying all submissions, divided into six tabs:  Not Assigned, Assigned, Completed, Agendas, Pending Action, and Outstanding Board Tasks.  When you open the Submissions link, default tab is the Not Assigned tab.

“Submission Type” filter, the search results shown in the queue will display the Corrections and Review Response forms along with the same type of forms that were not sent back to the study team.

Not Assigned

Any new submission that is unprocessed will populate within this tab. The columns listed in the Not Assigned tab are as follows:

The column headings can be used to sort the submissions in ascending and descending order.

 

Display Submissions By – This will change the display of the list of submissions.  Whatever number is selected (IRB, Proposal, or IBC, depending on what other modules are turned on) will appear as the column heading.

or (Display Response) – If an icon appears in this column, then there is a submission response or correction available for viewing.  A green icon indicates there is an attached submission correction that was made prior to the board meeting, a red icon indicates there is an attached submission response (for submissions already reviewed).

Ref Number – Whenever a form is created in iRIS™, a unique Reference Number is created for that submission. This number will display in this column.

IRB, Proposal, or IBC Number – If your system is setup to automatically generate an IRB Number for each study submitted, the number will display here.

Type – This is useful to quickly recognize the type of form that was submitted to the review board.

Date Board Received – The date that the board initially received the submission will display here.

Expiration Date – The IRB Expiration date assigned to the study will display in this column. Brand new studies will not have an expiration date assigned yet, but any continuing studies that submit items to the board will have the date populated in this column.

Principal Investigator – This column displays the name of the Principal Investigator designated on the study.

Assigned Analyst – If an analyst has been assigned to this submission, the name will display here.

Study Classification – This column displays the study classification assigned to the study.  The display of this column can be controlled through the Review Board Administration and may or may not be activated in your system (refer to the Review Board Administration Manual).

Risk Assigned – This column displays the risk assigned to the study.  The display of this column is also controlled by the Review Board Administration in the Configure Board Properties and may or may not be activated in your system (refer to the Review Board Administration Manual).

Assigned

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

This page lists any processed submissions, and contains the same columns and information as the submissions described in the Not Assigned section of this document plus the following:

Review Process – This section will display the review process selected for this submission.

Assigned Reviewers – If reviewer(s) have been assigned to this submission, their name(s) will display here.

Completed 

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

The search tool contains a list of processes available to search by Review Process, Submission Type, Date Board Completed, Etc. You can search by additional criteria below by indicating study information or personnel associated to a study. Click the Reset Find Options button to refresh the page will reset the search result.

Additional fields on this page are:

Letters – An icon will appear in this column, when outcome letters are created for a submission.  Hover your mouse over the icon and the name of the letter created will be displayed.

 

If the letter has already been sent, ‘(sent)’ will appear after the letter type.

Study Number – This column displays the Study Number associated with the study.

Date Completed – This displays the date that the submission was completed.

Department - The Department filter has a dropdown list, and departments can be added by clicking the green plus button. This filter and column are only displayed if the property rb.use_department_displayed is set to “Yes”.    

                                                                                                                                                                                                                                                                  Clicking the green plus button prompts an ajax window to be prompted where departments can be searched, and many departments can be added at once. When departments are added, the filter allows the system to search for studies associated with all of the selected departments simultaneously. The results from the search are displayed in the queue, and the Department column displays the department name. Once departments have been added, a red minus button appears next to the green plus button. To delete a department, the selection needs to be chosen and the red minus button must be clicked.

Agendas

The Agendas tab will open to the next upcoming meeting for the review board. This page will list out any submissions assigned to this meeting date. Submissions will populate in categories, based on the type of submission.

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

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

For more detail on Agenda submission processing see the IRB Meeting Agenda manual.

Pending Action

The Pending Action tab will open a list of submissions that require a response or a specific tasks to be completed by the study side before the submission can continue.

Outstanding Board Tasks

The Outstanding Board Tasks tab will open a list of submissions that require action from the review board side. Here, the tasks type and task assigned will show what task needs to be completed and who was assigned the task.

 

Processing Submissions

When you open a submission from the Not Assigned tab, you will open the submission processing pages. These pages will present the RB with information and tools to process a submission form. Depending on the way the form is processed, you may or may not see certain tabs (on the left side menu).

As you step through the processing screens, the area in the middle of the page will update with information related to the tab you selected. At the top of the page is a study header that will remain on the page while you complete your processing.

Listed in the header:

IRB Number – This is where the IRB number for the study being submitted will display. If the IRB number has not been assigned, then the Study Number will display here.

PI – The (Primary) Principal Investigator will be displayed here.

Type of Submission – The type of submission (Initial Review, Adverse Event, etc.) appears bolded at the top of the screen, next to the PI. 

Study Menu Bar – Mouse over the menu bar to open a drop-down menu.  The menu bar allows users to quickly access any component of Study Management.  There are four tabs:  Protocol Items, Miscellaneous, and Submission Forms and Additional Attached Forms (the items are divided into sections corresponding with sections found on the Study Management page for the study).

Reference Number – The submission reference number displays here in bolded red letters.

Project/IRB Number – Depending on your configuration of iRIS™, the project number or IRB number will display here in bolded red letters.

Study Title – The full title of the study appears here.  If the title is longer than the space provided, you may use the scroll bars to view the entire title.

Study Status – The status of the study should display Pending – Submitted for Initial Review when the Initial Review form is first received by the IRB.  This status will change depending on what part of the review cycle it is in.  The status is also color coded for easier identification.

Expiration Date – If the study has been given an expiration date, it will display here.

General Information

The first tab in the submission processing screens lists brief details about the Study being viewed. You can view General Information related to the current submission you are processing, as well as study specific information. The summary detail on this page is the same information listed in the Not Assigned, Assigned, and Completed tabs. From this page, you can view basic details about the study and see the listed study personnel, their COI status (if applicable) and their training status.

The General Information tab allows you to gain a brief summary of the study and submission to begin your pre-review.

If a user has multiple board access and the submission has been sent to different review boards, users will be able to see an option to switch between the boards through a link located in the Submission Processing Queue. An open submission with association to multiple boards will create links to the boards that the user has a role in, in the General Information tab.

By clicking the different boards associated with the submission, it will open the submission under the board that was clicked on as long as user has access to the specific boards.

General Information displays the Study Number and also pulls in the Master Lay Summary or the Study Abstract from the submitted study application. It also shows other components that can be turned off and on like codes and Study Classification etc.

The codes are another identifier that users can be used to identify their studies. To access this or to have more information about the codes, please contact your system administrator.

The master lay summary can be edited by clicking on the link, Edit the Master Lay Summary or Edit the Study Abstract.

A pop-up editor will open, allowing you to make any necessary changes. When you are finished, click the Apply button.

Below the Master Lay Summary is the Submission Summary. This is a field where you can add a summary for the submission you are processing.

Also displayed are any previously entered Internal Comments. These are entered in a later part of the process and are used more for additional rounds of the submission, so when you first open a new application, this field will not have information to display.

Listed below the General Information, you will also be able to view the associated Departments and the Study Personnel.                                       

Additional information can be viewed about Study Personnel by clicking on the icon next to the username. This will open Contact Information related to the user.

If your system is also using the Conflict of Interest Module, a column displaying the study personnel’s COI standing will be displayed. If your mouse is hovered over the COI icon, you can gain additional information about the user’s COI.

You can also track the study personnel’s training status with the IRB. Training is configured to be checked in the workflow, so by the time a submission reaches the IRB, the current status of training is displayed. If there have been any training updates for study personnel between the time of submission and when the IRB begins the submission processing, you can get the most current information by clicking on the Update personnel status to the latest button.

iMedRIS has extended the functionality which enables review board members to Unlock Submission for Editing from different rounds accessible in the Miscellaneous lab.

 

Studies that were already completed will be edible except for the “Review Outcome” field within the Outcome tab. However, if the finalized meeting minutes are published for a certain round, then that submission round is locked. The only way board members can unlock that round is if the finalized meeting minutes are unpublished. This functionality will also allow review board members to unlock rounds of submissions that were sent back to the study team for correction and were already opened by the study team.

There are many rounds within this submission, two of which have been “Returned for Corrections”. All of these rounds are now editable, the Review Board can unlocks the rounds by clicking the Unlock Submission for Editing button within each form.

After clicking the Unlock Submission for Editing button, a new button which reads Lock Submission from Editing appears. Board members should click this button when they have made the desired changes to the round.

After unlocking a submission, board members can edit the submission, but cannot alter the Review Outcome field. When navigating to the Outcome tab, the Review Outcome field is visibly read-only, and cannot be altered. Board members can however edit everything else on the screen, including the Protocol Status.

Submission Components

Submission Components will display the submission form(s) and any items associated to it. From this page, you can pre-review any of the submitted items including the study application, any attached consents, and study documents. You will also be able to add comments to the attached items to later use as Stipulations, if the submission needs to be returned to the PI for pre-review changes.

This page will also be used when a submission is returned to the IRB with corrections. Any revisions created can be viewed and compared against previous versions. As the submission is modified, this area will contain a list of originally submitted items as well as any new versions and attachments.

A table on the page will list out the details of the submitted items, starting with the most top-level form, working down to document attachments. 

There are four groups of items that may or may not display as part of the submission package, depending on what the study included with their submission form.

Submission Form(s) - In the example shown above, the Initial Review is the top-level form, or parent form for the submission. Enclosed within the Submission Form are all of the items listed below as attachments.

Application – This is the main application form that was completed for this submission. This form will only display if it was attached to the parent submission form.

Consent Form(s) – Any consent forms that were attached to the parent form will display in this group.

Document(s) – Any additional study documents that were attached to the parent form will display in this group. The study documents are often categorized when they are uploaded to the study, so there will be additional categories below this group.

Document Versions

When a new submission is processed, the attached items will all be in their original state, no new versions have been created at this time.

The documents are all versioned x.0, indicating they are in their original state. x denotes the starting version number, which can be any number for consents and study documents, based on what version they started out at when they were uploaded to iRIS. .0 denotes the iRIS version of the document. When a revision of a document or submission form is created in iRIS, this number will increment by 1. If you were to return this submission to the PI, requesting a modification to the consent form, iRIS would assign version x.1 to the new version, allowing you to see that there is more than one iRIS version associated to that particular document.

When a form or a document has been revised, the number will change, as shown above. The Revisions column will populate with a folder icon that you can click to display any previous versions of that form or document.

You may view the previous document by clicking on that item.

Viewing Submission Items

The name of the submission component and the item version number will display in the Current Submission Rounds column. You can click on the name of the item to open and view. 

Viewed submission components will change color. Any form, application or document you open to view or add comments to will then highlight green. Submission components that you have not opened will remain un-highlighted.

You can reset the viewed forms and documents by clicking the Clear Viewed Item(s) button in the ribbon above the Submission Components table.

If you open a submission form or the application, the form will open allowing you to scroll through the form and see the content of the form.

If you open a consent form or other study document, a new page will open displaying review board details about that document. At the time of pre-review, you will not be changing any of the details on this page, this will be discussed later.

At the top right of the page is a table containing two columns: View the Unapproved Consent and View the Approved Consent (which will be empty at this time, as there is no approved consent). You can click on the icon of the document in the View the Unapproved Consent column.

This will open the consent or other study document within the window if the file is a Microsoft Word file. Other attachment types are not supported.

Commenting 

You can add comments to any of the questions in the submission form, and to any of the application questions after the study shell (the first three sections of the application).

Questions in the form that have the commenting feature will display the Comment icon to the right of the question.

Click on icon to add a comment.

A Reviewer Comments Editor will open within the page, allowing you to type any comments. Click the Save icon when you are done or click the red X at the top of the editor if you do not want to add any comments.

Questions in the form that have a comment added will display a changed icon. You can modify or remove your comments by clicking on the icon again.

Comments for Consents and Other Study documents will be available when you are viewing the documents.

Users can then click on the On button in the “Highlight Comment Mode” to open another window where users can highlight and comment on specific areas of the document.

When the user highlights a word of phrase in the document, it will turn yellow and a small pop-up screen will appear where the user can input the comment. Click Save when the comment has been made to save the comment to the document.

The comment will be added to the document and will appear at the bottom of the window. Users have the option to Edit, Reply, and Delete the comments as well.

The comment will also show up right under the Highlight Comment Mode button under the “Comments” column.

Here, the user can delete the comment, hover over the comment to show the comment, or click on it to enter the window again to see the highlighted section and the comment.

Special Note: This functionality only works with RTF or Microsoft Word files.

More Details

Each submission component will have additional information, like submission dates, stipulations and review outcomes, depending on what processes have been applied to the components.

The icon to the right of the submission item is where you can click to see these additional details.

When you click this icon, an area below the submission item will populate with the details.  This is helpful for items you have received into the submission queue multiple times. You will be able to see when an item was originally submitted, as shown above. This is helpful for items that have been submitted several times. Newer items associated to the submission would have newer dates than components that have been associated longer.

Once you begin to send items back to the study for corrections, the information in the details area will update. An example listed above shows stipulations that were associated to a Study Application that were returned with the latest round of the submission.

Consent forms and Other Study Documents will display when they were originally submitted as well as any approval information associated.

Expand All – Located above the submission components table is a button that will allow you to expand or collapse all the details at once. When you click this button, the additional details for all the submission items will expand to display full detail.

Compare Item(s)

Submission components that have multiple versions can be compared using the Compare Tool.

The first column in the Submission Components table allows you to select which items to view. Before you can view an item, you would need to open the yellow folder icon to access previous versions. Also, note that you cannot compare items that are not the same item (cannot compare one version of an application to a consent form, etc.).

Items in List View/Folder View

You can change the view of the components to List View or Folder View. Folder View is the default view. When you click Items in List View, the button will change to read Items in Folder View.

Folder View

Folder View will list out all of the submission components, regardless of which round they were submitted with. Any item that has more than one version will have the yellow folder in the Revisions column.

You can click on the folder to view the previous version. You can also use the Compare Tool to compare the different versions. To see when components were initially submitted you can click on the More Details icon.

List View

List View allows you to view components as they relate to a certain round for the submission. A round is tallied each time a submission is returned to the study for corrections. Any submission can be sent back multiple times with no limit for pre-review changes or post-review corrections, so a submission can have an unlimited number of rounds. For each round, the study will revise forms and documents and add new consents or study documents, in response to any IRB stipulations. This creates new information each round – revised submission forms, revised consents and study documents, and new consents and study documents.

With List View, you can filter by Round Number to see what is related to a specific round.

When you first click Items in List View, you default to the most current round. A new field populates on the page allowing you to select a round from the drop-down list. The Compare column is not applicable in this view, because you are only looking at the current rounds document.

For a round selected, the only components that display only pertain to that round’s documents. This would mean any unchanged form or document from the previous round (in the example above, the Initial Review Submission Form was unchanged from the previous round). Any new versions will display (the Study Application and Consent Form were both revised with this current round) and also brand-new attachments will display in this round (the Pre-Review Response Form was added in round 2).

You can switch the round numbers. In the screenshot below, the round was changed to Round 1. The view of the submission components has changed to the items associated to Round 1 (Initial Review Submission Form, IRB Application, a Study document and Consent Form).

In addition to viewing components associated to a specific round, you can choose to combine all rounds for a summary. If you change the filter to All Rounds, the page will update and display all components ever associated to the submission. A label next to each component will detail which round the component was submitted with.

The List View display is more applicable for submissions that have been returned for changes.

Attach New Component

You have the ability to add attachments to the submission. You can add Consent Forms or Other Study Documents.

Start by clicking on the Add New Component button.

A window will open within the browser allowing you to specify which type of document you would like to add to the submission.

Attaching Consents

If you choose to attach a Consent form, you will be directed to the list of submitted Consent forms on the study. Any consent that has already been attached to the submission will be indicated by Already Attached in the first column.

You may choose any consent from the library, or you may revise an existing consent or add a completely new consent document.

If you choose to add a new consent form, you will be directed to a page that allows you to enter in the consent information. You can also upload a form from this page. Note that the Reference Number is already associated for you, because as you create the consent record, the system automatically associates it to the submission you are processing.

After entering the information, click the Save Changes button.

You will return to the list of consents on the study. The new record will display, indicating the consent is attached to the submission. Note, that there is an indicator that the revision was created by the IRB.

You can choose to revise an existing consent form record. If you do this, you will be brought to a new page that indicates the new version of the consent form. You can modify the information on this page or check out the document. When you are finished with the revisions, click the Save Changes button.

You will return to the list of consents on the study. The new version will display, indicating the consent version is attached to the submission. Also, note that there is an indicator that the revision was created by the IRB.

After adding the consent form, click the X button to return to the Submission Components page.

Any document you add will display in the table, along with the note that the version was added by the IRB.

Attaching Other Study Documents

If you choose to attach Study Document, you will be directed to the list of Study Documents associated to the study. Any document that has already been attached to the submission will be indicated by Already Attached in the first column.

You may choose a document from the library, or you may revise an existing consent or add a completely new consent record.

If you choose to add a new Study Document, you will be directed to a page that allows you to enter in the document information. You can also upload a document from this page. After entering the information, click the Save Changes button.

The new document will display in the list, make sure it is selected then click on the Attach button

This will return you to the Submission Components page with the added document listed. Any documents added by the IRB will also display the note indicating such.

Create PDF Packet

You can select multiple components to be bundled and printed.

The first step: check off which items you would like to print in the Include in PDF Packet column. Then click the Create PDF Packet button.

The second step: organize your selected items in the order you would like to print them. Do so by hovering over the item (a blue arrow will appear in the Packet Order column) and dragging it to the desired location. When you are done, click the Generate PDF Packet button on the bottom right of the window.

Completing step two will send any documents you selected to a PDF view. This will open in a new window. From here you can save the document for viewing and printing later, or you can print now.

 

Approve Attachment(s)

Documents can be approved from the Submission Components page. You can individually approve documents by clicking on the document or you can use the Approve Attachment(s) button to approve multiple documents at once.

When you have clicked the Approve Attachments button, a new page will open, listing all the Consents and Study Documents. This page will list out the document Title, the Version Number and Date and the Original file. You can click on the icon in this column to view the document.

To approve documents, you need to select which ones you will be approving. Do this by clicking the check box next to the document.

After checking the approve check box, you must select a Review Outcome for the document in the Review Outcome column. If you are approving all documents, you can use the Select All button and the Approve All button, to select all documents and set all outcomes to Approved.

After approving, enter in the Approval and Expiration Dates, if any. If you are approving documents after a meeting and setting Outcome information, these dates may pre-populate with the same approval and expiration information provided to the submission.

When the dates have been entered, the last step in approving documents is to click the Approve button and the system will approve the selected attachments. When you approve a document, the system will convert it to a PDF and stamp the document with your institutions Consent and Study Document stamp. You can access the approved document in the Stamped column of this page.

When you return to the Submission Components page, any document you approved will update with a note that the document is approved if an approval date was given.

Compare to Last Approved and View in Separate Window

Two new features have been added to the Submission Components tab in in the Submission Processing Queue. Two new functions and columns have been created to compare the last approved version of an application with the current version of the application attached to the submission, and to view the application in another window.

A new column, View in Separate Window, has been added which provides the user the ability to open the component of a submission in a new window while the user is still in the main screen.

 

The column Compare to Last Approved gives the user the ability to compare forms and documents that have been approved to the latest version.

 

A new window will appear with the side by side comparison of both documents. Changes will be denoted in different colors: additions in green and deletions in red.

Correspondence

This tab allows users to communicate with other board members or study personnel.  This section will also allow users to send the correspondence to an email address outside of iRIS.  When you choose to access the area to add a correspondence, the screen will look like this:

The page will list all correspondences associated with the submission.  To add a 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 initially available on the recipient’s home screen under the Not Opened Correspondence tab.

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

Recipient(s) - Choose from a list of key personnel and members on the Review Board.  To select the individual(s), check the box(es) next to the name(s).  To select all of the listed Personnel, select the icon above the checkboxes.  Select the Save Changes button when finished.  

Additional Recipient(s) - 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, then click the Remove Selected Contacts button. Click the Save and Return button to return to the correspondence page. 

Reply to List/ Additional Reply To - Add users here if you would like them included in any replies to the correspondence outside of iRIS. 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 OK 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 the 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 drop-down 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 Icon or 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.

If you do not see a user or a role to send the correspondence to, the user may be hidden. The Review Board Administrator can set up different roles to be able to receive and be seen on the correspondence contact list.

Submission History

This tab will display the current workflow step for the submission, and any previous steps the form has taken.

Any steps that are still in process will be displayed at the top of the list with the status of In Process.  The steps that are completed will be displayed with the status of Completed.  Once a step has moved from In Process to Completed the step will order by the date/time stamp. If any step was cancelled, the status will be cancelled, and the Cancel icon will be displayed.

The date the process was received is displayed in the Date Received/Date Completed column.  The Event Description will display the description of the process.  Each item in this table can be expanded to show more details in the Event Description.  This can be done by clicking the expand button:

This will cause the item to appear as so:

To minimize this view, simply click on the small collapsebutton.

If the submission needs to be routed for further signoff before review, the RB Coordinator can use the Add Additional Signoff button at the top of the Submission History page.  This will allow them to route the submission for signoff (similar to the process of the submission undergoing signoff by the PI).  These additional signoff routings can be removed by using the Delete Additional Signoff button.  Either way, an entry will be created in the workflow and any associated user chosen for signoff will be notified via a task on their home page and an email notification (if one has been configured).  

A new property has been added to the new version that allows the name of the current user to be included in specific tasks completed. This new property is under System Administration. Please contact your system administrator for more information. When set to “Yes”, the name of the current user will be included in the task name when the task was created.

When set to “No”, the name of the current user will not be included in the task name when the task was created.

Note: This property only affects the Submission Histories while the property is on. If the property is turn on and a user is assigned a task, the assigner’s name will be shown. However, if the property is turned off and another task is assigned, that task will not have the assigner’s name associated with the task. For example, in the screens above, the property was turn on while Adam Smith was assigning the task. However, after he assigned the task, the property was turned off by the System Administrator. When he, or another user, went into the Submission Processing Queue and assigned another reviewer, the current user was not included in the task name when the task was created. The property being off however, did not change the previous task detail that included Adam Smith.

Pre-Review Screening

This screen is used to assign the analyst, process the submission (i.e. pre-review changes assigned to agenda), and assign reviewers.

Note: Remember to click the Save the Pre-Review Screening button if you make any modifications to this page.

Assign Analyst – Select the user who will provide and/or coordinate comprehensive technical and compliance pre-review of study submissions.  The user assigned as the Analyst will receive a homepage task related to the submission until the submission form is closed by processing. The Analyst will also receive submission related notifications – Reviewer Complete Notifications, Outcome Letter Signoff Complete Notifications and Review Response Complete Notifications.

A new button, View Analyst Workload, has been added to the Analyst Assignment section of the Pre-review Screening tab. Users can now check the workload of analyst by selecting the View Analyst Workload button before assigning the analyst to a submission. 

Users can select an Analyst from the Assign Analyst drop-down menu. When the View Analyst Workload button is selected, a new page will open a listing of analysts and the number of open assignments currently assigned to them.   

 

Users can select the yellow folder icon to expand a view of all assignments for a particular member and view the study details for those assignments. This page can be printed if desired. Select the Close button to return to the Pre-Review Screening page. 

IRB Number – Depending upon your system settings, the Review Board number may have been automatically generated in your workflow or it will be required for you to manually enter in or generate by click the “Generate Number” button.  If you do not have this button next to the text field, it means that your IRB Numbers have already been automatically assigned.

Review Fee – This option is used for IRB invoicing and may not be available for your system. For more information on how this functionality is used, see the IRB Invoicing document.

Determine Review Process – Use the selections presented here to process the submission form. Once you select a review process and save the screen, you will be able to assign reviewers and more processing tabs will populate on the screen.

Not Assigned - The submission will default to this status when it is first submitted to the submissions queue. This indicates that a Review Process has not yet been assigned and causes the form to populate in the Not Assigned tab.

Full Committee Review – This option allows you to process the submission to a full board review. After this option is selected, the committee and meeting selections will be displayed.

Expedited – If this option is selected, the screen will refresh with the option of selecting a reviewer(s). Once you have finished with your selections on this page, click the Save the Pre-Review Screening button. Again, the new tabs will be available for that submission. This option can also be turned on/off in your Review Board Configurations.

Exempt - If this option is selected, the screen will refresh with the option of selecting a reviewer(s). Once you have finished with your selections on this page, click the Save the Pre-Review Screening button.  Again, the ten new tabs will be available for that submission.  This option can also be turned on/off in your Review Board Configurations.

Process Administratively – This process is a useful action for submissions that need to be processed through the review board but not reviewed. Selecting this review process will also allow you to select reviewers for the submission, if the reviewer option is turned on.  The same tab options will also appear after this option is selected and saved.

These are the most commonly used Review Processes. You can also hover your mouse over the icon to see descriptions of the different review processes.

Assign Reviewers

This option will be available on Submissions that have been assigned a review process.  This area can be turned completely off in Review Board Configuration – System Setup.  This section allows you to assign a user within the review board to review a submission.

To add a reviewer, select the Add Reviewer button.

The screen will refresh allowing users to select from a list of reviewer roles that are pre-defined in the Review Board Configurations (see the Review Board Configurations – List Maintenance Setup manual for more details). 

After the role (a non-Ad Hoc role) is selected, the screen will refresh to allow you to select from a 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 Pre-Review Screening button.  The screen will refresh with the reviewer’s information.

You may add as many reviewers as needed.  A reviewer can also be deleted from the list simply by clicking the icon in the first column.  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 submission is waiting for their review.  This notification can be set up in Review Board Configurations.  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.

Comments to Reviewers

When you assign reviewers to a submission, you can add comments to the reviewers.

As soon as you create a reviewer assignment record, a new button will populate at the top of the reviewer table called Add Comments for All Reviewers.

Clicking this button will open a popup within the browser where you can add any information you would like to communicate to the reviewers assigned to the submission. Click the Apply button at the bottom right of the window to add the comments. If you do not want to save the comments, click the icon.

When comments have been added for the reviewer, the button will change to View Comments for All Reviewers. You can click this button to view or modify the comments.

Any comments added can be displayed within the Reviewer Checklist using the data value Submission Comments for All Reviewers in the System Forms Designer.

Reviewers Workload

You can check the workload before adding a board member to review a submission.

Above the reviewer table is a button called View Reviewers Workload.

When this button is clicked, a new page will open listing board members and the number of open assignments currently assigned.  You can click on the yellow folder icon to expand a view of all assignments for a particular member and view the study details for those assignments. This page can be printed if needed. Click the Close button to return to the Pre-Review Screening page.

Reviewer Assignments

When you assign a reviewer to a submission, 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 Outstanding IRB tasks group.

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 submission components for the reviewer to view.

The screenshot below shows the data value for the Current Submission Components. The reviewer can click to open any of the documents to view them.

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. Select “Yes” in this section, this will flag the review as complete.

When all reviewers on the submission have completed their review, the analyst task will update to indicate all are complete and will also receive a separate Submission Reviewers Complete task, as shown in the image below.

Review Checklist and Comments

This area of the processing screens will contain information about any reviewer assignments for this submission. If reviewers have been assigned in the Pre-review Screening tab, a record will populate on this page displaying the review status for this assigned reviewer. Members can also access this portion of the submission to add any comments desired.

Reviewer Check List

Any reviewer that was assigned on the Pre-Review Summary tab will display on this table. As the review board coordinator, you will be able to see the reviewer’s status.

View/Edit – Depending on the status of the review, this column will change.

When you are viewing this page and the reviewer has not yet started their review, the column will display text indicating the form has not been started yet.

Once the reviewer begins the review, the column will update to display an open book icon. You can click on this icon to view a Read Only version of the reviewer checklist.

If you access this page as the reviewer, the icon in this column will appear as a notepad with a pen, meaning you can open your reviewer checklist from this page and fill it out.

 

Reviewer Role – Displays the role assigned to the reviewer.

Reviewer – Displays the name of the reviewer.

Completed? – Indicates whether or not the reviewer is complete with the review. This column will either display “Yes” or “No”.

Date Notified – Displays the date the reviewer was notified of the review assignment.

Date Completed – If the review status is “Yes”, the date the reviewer completed the review will populate in this column.

Share Review with Other Review Boards – You can choose to share this review with other involved review boards. Click on the icon in this column to display a list of available review boards.

If another review board will be receiving this submission, you may share the review with that review board. Select the review board(s) from the list then click the Save Selections button.

If you have selected to share the review with other boards, the column will update with a green background to indicate this particular review has been shared. 

Member Check List

This section functions similar to the Reviewer Check List table.  Any member of the Review Board can optionally fill out the same form the assigned reviewer fills out. This section can be turned on/off in Review Board Configuration – System Setup under Board Configuration Options in the Submission Review Properties group.  

Any member wishing to complete a checklist can click on the Add Member Checklist. This will open the Reviewer Checklist form, as defined in the System Form Designer.

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 Member Check List table populates with an entry. The member can access their checklist by clicking on the Edit icon.

Member Comments

Any board member can add comments to the submission to be discussed at the meeting.  This section can also be turned on/off in Review Board Configurations.  

When adding a comment, a text editor will appear with two options, allowing the user to decide how they would like the comments to be displayed. If the member wishes to keep the comments hidden from other board members, the Display my comments on the review checkbox would 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 would 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 Summary

The Review Summary page will contain a summary of any comments added to any of the submission components and a summarized view of any reviewer checklists that have been completed. From this screen, you can choose to merge comments from the components or from the reviewer checklist into Submission Discussion, into an Outcome Letter or into a Stipulation.

When a reviewer has completed a Reviewer Checklist, the answers supplied in the form will be summarized here with three checkboxes next to each question. Also, any comments added to a submission component will be listed above any checklist summaries. Shown in the screenshot above are the summarized comments the reviewer had added to the Study Application. The columns for the comment’s summary are as follows.

- This column is used to flag comments to be merged into the Submission Discussion, the next tab in the Submission Processing Screens. Typically, any item that should be flagged for review at the meeting would be merged to the Submission Discussion.

- This column is used to flag comments to be merged into an Outcome Letter when it is generated at a later time. Any item that should be communicated to the study in the formal letter would be merged.

- This column is used to flag comments to be merged into a Stipulation. Any comment that originated from a submission item that is then merged into Stipulations will link the Stipulation to that item in the submission components. This is discussed in more detail in the Stipulation section below.

Name – The name of the user who created the comment displays here.

Rank – Some comments can be ranked. Comments added to the Review Checklist through the Reviewer Submission Comments data value in the Reviewer Checklist. This will display either Major, Minor or will be empty.

Reference – The Reference column indicates where the comment originated from. This can display the Submission Form (Initial Review, Continuing Review, etc.), the Study Application, the Consent Form or Study Document. This column will also display the version number for the form that the comment was made to.

Item Number – Comments added through the Reviewer Submission Comments data value can also be given an Item Number.

Below the components comment summary is listed the reviewer checklist summary. These are the questions and answers coming from the Reviewer Checklist. If more than one member has completed the checklist, they will be listed together in this view. The same three columns used to merge the comment are available here. Also listed is the name of the Reviewer and the Question and Answer from the Reviewer Checklist.

If you chose to merge any of the comments into the Submission Discussion, Outcome Letter, or Stipulation, click the check box next to the comment in the appropriate column, then click either the Merge Comments into Stipulations button, the Merge Comments into Submission Discussion button, or the Save the Checklist Status button.

Submission Discussion

Submission Discussion can be used to capture information related to the submission. These can be notes from the analyst or any discussion about the submission that take place during a meeting. Items from the Reviewer Checklist can also be merged into the Submission Discussion. Submission Discussion can then in turn be merged into letters and meeting minutes.

If any comments were merged from the Review Summary tab, that information would display in the discussion similar to the example above. You can modify the discussion by entering that information into the text editor. Click the Save Submission Discussion when you are finished.

Stipulation

The stipulations tab allows you to manage stipulations for the submission. You can create new stipulations and manage stipulations that were merged from Review Checklist and Comments. Later, when you are processing a submission response or submission correction, you will be able to status a stipulation as closed or unmet.

 

When you initially open this page, no stipulations will be added, unless they had been merged from Review Checklist and Comments.

Add a New Stipulation

You can add a new stipulation by clicking on the Add New button at the top right of the screen.

A new page will open allowing you to enter details for the stipulation. There are three parts of the stipulation; the Stipulation Type, associating components to the stipulation, and the Stipulation Content. The Stipulation Type and Stipulation Content are both required fields. You may choose to associate a submission component to the stipulation, if the stipulation is related to a submitted item.

Enter in the Stipulation Content. You can copy and paste from another source, or you can type in the stipulation, using the tools in the editor to format your stipulation text.

Choose a Stipulation Type from the dropdown list. There are three types available. 

Stipulation must be addressed

 

This Stipulation Type is the most commonly used for a stipulation. A stipulation that must be addressed is a required change requested by the IRB. Choosing this type of stipulation indicates to the study, that this stipulation must be addressed before any further action can be taken on the submission.

Comments that must be addressed

Comments that must be addressed are stipulations that require a separate follow up due date. Any stipulation or recommendation from the board that can be addressed separately, from the submission approval criteria would be given this type. When you select Comments that must be addressed from the drop-down list, a date field will populate, allowing you to specify what the stipulation follow up due date is.

Comments

The Comments Stipulation Type is general recommendations set by the board. This type of stipulation requires no action from the study team.

Associating Components

After selecting a Stipulation Type, you may choose to associate the stipulation to a submission component. Associating a component to a stipulation will attach the stipulation to that item, so when the study accesses the stipulations, iRIS will direct them to that submission component. This is helpful for stipulations that require the study to make changes to any attached submission form, application, consent form, or study document. Rather than search for their document or form to make changes, the stipulation will do the work for them. If the stipulation is a requirement for a new attachment of a consent form or study document, it would not be necessary to associate the stipulation to a previously submitted item.

Begin by clicking on the green icon Attach Components to Stipulation or click Add Component(s).

A new window will open where you are able to specify the component association to the stipulation.

Select one of the three options to initiate the component link:

1. Associate Component Removal
2. Associate New Component
3. Associate Existing Component

Component Removal

To indicate that a specific document needs to be removed from the Submission, click the Associate Component Removal button. Clicking this button will direct you to a page that will list the existing documents attached to the submission. Select the component you would like to request to be removed from the submission and then click the Add Link to Selection, as shown in the screenshot below.

Once an item is associated for removal, you will be returned to the previous page with detail related to the Remove Attachment request. If you made an error associating the Remove Attachment request, you can delete it from the stipulation by clicking the icon in the Detach column. If you need to change the document requested to be removed, click the icon in the Edit column. Note: the image in the Mod. Request column indicates that the request linked to this stipulation is a Remove Attachment request.

New Component

To indicate that a specific Study Document needs to be added to the Submission, click the Associate New Component button. Clicking this button will direct you to a page that will list areas within the submission that contain document attachment data values. Select the component you would like to request to be added to the submission and then click the Add Link to Selection, as shown in the screenshot below.

Once an item is associated to the stipulation, you will be returned to the previous page, with detail related to the Add Attachment request. If you made an error associating the Add Attachment request, you can delete it from the stipulation by clicking the icon in the Detach column. If you need to change the document requested to be added, click the icon in the Edit column. Note: the image in the Mod. Request column indicates that the request linked to this stipulation is an Add Attachment request.

Modify Existing

To indicate that a specific Submission Form, Study Application, or Study Document currently attached to the submission needs to be modified, click the Associate Existing Component button. Clicking this button will direct you to a page that will list all items currently attached to submission (including the submission form itself). Select the component you would like to request to be changed and then click the Add Link to Selection, as shown in the screenshot below.

If you select a form to include, additional Section and Question information will populate on the page, allowing you to specify exactly what question needs to be modified.

Once an item is associated to the stipulation, you will be returned to the previous page with detail related to the Modify request. If you made an error associating the Modify request, you can delete it from the stipulation by clicking the icon in the Detach column. If you need to change the modification requested, click the icon in the Edit column. Note: the image in the Mod. Request column indicates that the request linked to this stipulation is a Modify request.

After you are done creating your component associations close the window using the (X) located in the upper right-hand corner. You will be directed back into the stipulation content page where you can make any changes to the stipulation content, attach additional components, and verify already attached components. Once you are done with this page click the Save Stipulation button located in the upper right-hand corner of the screen.

Note: In the example below, multiple request types have been associated to one stipulation. You have the ability to add as many request types as needed to each stipulation or you can create one stipulation for each request type.

After saving this page you will be returned to the stipulation tab of the submission processing screens. Any stipulations that have been created will be listed on the stipulations tab. The green color in the Link to Component column indicates that the stipulation has been linked to a component in the submission.

Note: The Study Side will respond to submission corrections using either the Return Response Form or the Pre-Review Correction Form (depending on how the stipulations were returned to the study from the Review Board). There are specific Data Values that must be entered into the Return Response forms that will allow this feature to function correctly. The setup of these data values can be reviewed by reviewing the System Administration – System Forms Designer manual.

After saving the Stipulation, you will return to the Stipulations tab and the stipulation will display in the table. The following fields display for stipulations added to the submission.

- You can delete a stipulation by clicking the checkbox in this column then click the Delete Selected button.

Edit – Click this icon to open the stipulation for editing. You will be able to change the Stipulation Type, Associated Components and Stipulation Content.

Sorting Number – Stipulations can be reordered based on the numbering here.

Stipulation Type – This column displays the Stipulation Type selected for the stipulation.

Follow-up Due – If the Stipulation Type is Comments that must be addressed, the Follow up Due Date provided will display here. For the other two Stipulation Types, Stipulation must be addressed and Comments, N/A will display.

Stipulation – The Stipulation Content will display here.    

Created By/Edited By - A Created By/ Edited By column has been added to the Stipulation Sent for Response table. This table keeps track of the name and date on when the stipulation created/edited.

Link to Component – If you have linked components to the stipulation, this column will appear with a green background. You can select the image in this column to change the association. If the stipulation does not have components associated, the background will display without the green color. You can click on the icon to associate components.

Add Multiple Stipulations

If you have more than one stipulation to add, you can choose to add them all at once by clicking on the Add Multiple button.

This is a tool used generally when you have a list of stipulations in a Word document. You can copy and paste the stipulations into the editor provided, add the Stipulation Type and then save the page to add all stipulations at once.

Each stipulation added will be listed as a separate record.

Add Pre-Defined

If you have a list of commonly used stipulations, you can define a list in Review Board Administration – List Maintenance Setup – Predefined Stipulations.

When you click on the Add Pre-defined button, a new page will open listing the available pre-defined stipulations. Check off which stipulations you would like to add and click the Save Selected Stipulations for Study button. 

The pre-defined stipulations will be added to the submission, creating a separate stipulation record for each pre-defined stipulation you added. You can modify the stipulation by clicking on the Edit button. You may also link the stipulations to components using the Link To Component column.

Merge From Review Summary

In the Review Summary tab, you are able to flag comments that can merge into the Stipulations tab.

If a comment was made within a submission component, it will be listed in the Reference column. The example above shows several comments that were made in the Study Application form. When these comments are merged into stipulations, the link to the Study Application will pull over as well, so when the study responds to the stipulation, they will be directed to that component.

In the Review Summary tab the column is used to flag comments to be merged into a Stipulation. Click the checkbox next to any comment that you would like to merge into stipulations then click the Merge Comments into Stipulations button.

A stipulation record will be created for each comment merged into stipulations. If the comment originated from a submission component, the Link to Component column will reflect the association. You can modify the stipulation by clicking on the Edit button and change the components association by clicking the icon in the Link to Component button.

 

Stipulation Responses

The stipulations created will be added into the Review Response Form, when the submission is returned to the study for corrections.  The Principal Investigator or designated personnel will need to address the stipulations within the Review Response Form and make the required changes, to the submission and its components and resubmit the form to the IRB.  

When the study responds to stipulations and returns the submission to the review board, the responses to the stipulations will populate in the Stipulations tab.

This will allow you to review the responses and status the stipulation, indicating to the system whether or not to close a stipulation. You can also indicate if a stipulation is not adequately addressed and copy it to a new stipulation to return back to the study again.

Click the icon in the Edit column to open details about the Stipulation Response.

By clicking the icon in the Edit column, it will open a Process Stipulation page. From this area you can choose a Review Action and provide a date that the stipulation was closed in the Date Closed date field. You would only supply a date if the stipulation is closed.

The drop-down list containing the Review Board Actions is a configurable list in Review Board Administration. Actions can be configured to tell the system whether or not a stipulation is considered closed or not. If the stipulation is given a type of non-closed, the system will copy the stipulation and the details of the stipulation, into a new stipulation record so it can be returned to the study.

Also displayed on this page is the Stipulation Type, the Follow-up Due, if any, the Stipulation Content and the response from the study in the Response Acknowledge and Response Statement fields.

You can also view the stipulations history, track stipulations, and add memos to stipulations from the menu bar located at the top of the screen. Hover over the Miscellaneous Menu and click to open the Stipulation History Link. You will be able to track all of the studies open and closed stipulation from this page.

Click the icon in the Edit column to open details about the Stipulation.

This will open a Process Stipulation page. From this area you can choose a Review Action and provide a date that the stipulation was closed in the Date Closed date field. You would only supply a date if the stipulation is closed.

Add a memo to the stipulation by clicking the Add Memo button on the top right of the page.

This will open a new page containing an embedded editor. You can copy and paste or type in your memo and use the tools within the editor to format your memo. Click the OK button when you are done.

This will add a memo record to the Process Stipulation page. More memos can be added, and your memo can be modified or deleted.

Returning to the Stipulation tab, you can also set the Review Action and the Date Closed for each stipulation. If you set the action to a stipulation that indicates the stipulation is not accepted and then save the page, the system will copy that stipulation record into a new stipulation to be returned to the study. The example above shows a stipulation given the action of ‘Not Addressed’. When the page is saved, a stipulation record is created.

You can set the Review Outcome for all stipulations at once. At the top of the table in the Review Action column is a drop-down list that, when an option is selected, will apply to the rest of the stipulations on the page.

After selecting the Review Action at the top of the table, the action will be applied to all stipulations.

You can then add the Date Closed date for the stipulations. If you do not enter a date, when you save the Stipulations page, the system will insert today’s date. The stipulations you mark as Addressed will close out in the system.

Internal Routing

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

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 is default to NO. After you select your routing personnel make sure you set the selection to YES and then click the Save Routing List button.

You can compile a list of users needed to complete an internal signoff on the submission.  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 drop-down list of 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.

Any users added to the routing will be listed in order. You can assign reviewer specific assignment notes to each user. These comments would appear to the assigned user in addition to the Assignment notes and would be private to the assigned user only. 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 OK button after adding your 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.

Once you have selected the appropriate users and added your comments, select “Yes” to 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 in the 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.  

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 signoff in a timely manner.  

Internal Routing Task

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

This will open a Submission validation page. The page will list the Submission and it’s elements defined in the Submission Processing Screens including the Submission Components, Assigned Reviewers and the ability to view their checklists, Submission Discussion, Stipulations, Outcome information, Outcome Letters generated for the review and finally at the end of the page the Internal Submission Routing information.

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

From the Submission Routing area, the user can indicate whether or not they are finished with the review. They can also add additional routing if needed or remove another routing task if needed.

If the user needs to comment back to the Analyst, they can click on the comments link that also contains their name.

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

When all the users assigned to the Internal Routing have completed their routing assignments, the analyst of the submission 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 the tasks on the home page, you can see when the users completed their assignments and if they had left any comments. You will also be able to add additional users to the routing, if needed.

Vote / Expedited By / Acknowledged By

 

Depending on the review process selected for this submission, one of the above tabs will display. If you have assigned the submission for a full board review, the Vote tab will appear. Expedited submissions will have the Expedited By tab and any Exempt submissions will display the Acknowledged By tab.

Vote

The Vote tab allows you to capture the meeting vote for a full board review submission.

You can capture the vote at the time of the meeting, or any time afterwards but before you complete the submission 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 pre-canned motions by selecting a template from the Pre-canned Motion text dropdown list; then click the Add Canned Language button. The Pre-canned language for the motions can be set up in Review Board Administration – List Maintenance Setup – System Setup – Setup Canned Motion.

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

Meeting Attendance will need to be set before voting can take place.  If attendance has not been set, voting board members will not display on this page. Once the attendance on the meeting has taken place, any voting member marked as present at the meeting will be listed here.

The vote type can be selected in the Vote column next to each Members Name.  Each member’s Specialty, Affiliation, and Alternate information can also be found under the corresponding columns.

After the votes for the motions have been set, select the Save the Members Vote button.  The vote will be saved and can be used to merge into the outcome letters and meeting minutes (see the Review Board Administration – System Setup manual).

Anonymous Voting

Depending on your Review Board Configurations, the motion you added may or may not be set for anonymous voting.  For more details on setting this configuration, please refer to the Review Board Configurations manual.

If anonymous voting is setup, then the screen will appear similar to the screenshot above.  Select the Add button to add a vote result, and a new row will appear.

Enter the number of members that voted for the selected vote type in the Number text field.  To remove a vote, select the checkbox(es) next to the appropriate vote type and click on the Remove button.  After you’ve finished entering your motion, be sure to click the Save button.  

Expedited By

If the submission has been processed Expedited Review, this tab will display as Expedited By. In addition to assigning an Expedited Reviewer in the Pre-review Screening tab, you can also indicate here who the submission will be Expedited by.

This page will display review board members. Next to each member’s name there will be a checkbox in the Expedited column.  By checking the checkbox next to the appropriate member(s), you will indicate the board member’s approval or acknowledgement, on the process of the submission.

If you make any changes to this page, click the Save the Acknowledgement button on the top right corner.

Acknowledged By

If the submission has been set to Exempt the tab will read as Acknowledged By.

This page will display review board members. Next to each member’s name there will be a checkbox in the Acknowledged column.  By checking the checkbox next to the appropriate member(s), you will indicate the board member’s approval or acknowledgement, on the process of the submission.

If you make any changes to this page, click the Save the Acknowledgement button on the top right corner.

Outcome

This section tab you can set the review outcome of the submission.  Depending on the setting of your software and the review process, the features on this tab may vary.

When you are processing an item that has been given the Review Process of Pre-review changes requested, the Outcome tab will simply contain the ability to modify, the overall status of the study. Often, before returning an Initial Review submission to a study for corrections, the review board will change the study status to something that will indicate the study is currently undergoing revisions.

If you modify the study status, click the Save the Submission Outcome button before proceeding.

When you are processing an item that has been placed on a full board meeting, you would come to the Outcome tab when you are ready to enter the outcome information, based on the review. If the process was Expedited, Exempt or Process Administratively, you would come to this page when you are ready to set the outcome information.

The Outcome tab allows you to set the outcome information for the submission. You will also be able to manage certain aspects of the study record from this screen.

IRB Review Outcome

The first portion of the Outcome tab contains submission approval information.

You would select the Review Outcome from the drop-down list. This is a configurable list defined in Review Board Administration. Depending on what outcome you select, you can control whether or not the submission is approved, not approved or needs to be returned to the study for a review response.

Approval Outcomes

To approve a submission, select the appropriate approval outcome from the Review Outcome drop down list.

Additional Information required will display “No”. Enter the Submission Approval date. This is the date the submission is approved. You would also want to change the Study Status to the appropriate status. When the review board sets the Study Status, the system will grant certain allowances to the study personnel. This is dependent on the settings for the Study Status configuration, as defined in Review Board Administration.

If you select an Outcome that will return the submission to the study, the column for Additional information required will flip from “No” to “Yes”. “No” indicates that when you complete this submission, it will complete out in the workflow. “Yes” will indicate the submission will return to the study for any requested stipulations by the review board.

If you are approving the submission, enter in the Submission Approval date. If you have selected an outcome that requires additional information, this field will change to read Follow up Due. You can enter the date the response is due back into the review board submission queue.

Tabled Outcomes

There are times when a submission item cannot be reviewed at a particular meeting date. If this happens, you can set the outcome information to a Tabled status and send the submission to a different meeting for review.

You would select the Review Outcome from the drop-down list and leave the Submission Approval and Study Status as is.

Denial Outcomes

If the submission is denied, you can set denial information in the Outcome tab.

Choose the appropriate Review Outcome. Leave the Submission Approval field empty and change the Study Status to a denied type of status.

Additional Information Required

When a submission needs to be returned to the study after a meeting, you would set the process in the Outcome tab, rather than go to the Pre-review Screening tab to set the Review Process to Pre-review Changes Requested. If you change the Review Process once a submission has been processed on an agenda for full board review, you may lose reviewer assignments and the information regarding the submission on the meeting.

Set the Review Outcome to indicate changes requested. When you select an outcome marking the return to the study, Additional information required will change to “Yes”. This means when you complete the submission, a Submission Correction form will generate and send to the study, containing Stipulations and the Submission Components.

If the review board has set a follow up due date, enter that date in the Follow-up Due field. You can change the Study Status if that is a requirement of your board.

 For Expedited, Exempt or Administratively Processed submissions, when you are entering the Outcome information, you will be able to assign the submission to an agenda.

Comments

Below the submission outcome information is a comments area for the submission. There are three types of comments, Internal Comments, Shared Comments, and Take Note.

To enter comments that will be viewable for the current review board only, select the Internal Comments link.  A text editor will be displayed allowing you to edit or add any comments.  To enter comments that will be viewable for all Review Boards that have access to this study, select the Shared Comments link.  A text editor will be displayed allowing you to edit or add any comments.

There is also a feature allowing you to enter a Take Note item.  A pop up with the Take Note text will open, every time a submission form is opened for that particular study. For example, a certain document that is normally included in the Continuing Review Process is submitted with the Initial Review. The Coordinator can create a Take Note reminder, so that in a year when the Continuing Review is submitted, the note will pop up when the Coordinator begins to process the submission.

Study Information

After you add the submission approval information and any necessary comments, you can then go on to set study-specific information. Listed below are the standard options available. When you are approving an Initial Review, you would enter in information related to Initial Approval, the Expiration Date, the Review Cycle, the Continuing Review Due Date, and Subjects Approved.

Later, when you are setting outcome information for other submission forms for the study (e.g. Continuing Review, Adverse Event and Modification), information in this area would pre-populate from the study record. You would change only what needs to be changed based on the outcome of the review.

The fields in this area are as follows.

Meeting Date – if the submission was placed on a full board meeting, this field will populate with the meeting date.

IRB of Record – Use this option to specify whether the board processing the submission is the IRB of Record. Initial Reviews that are submitted to the IRB will default to “Yes”. If the IRB is not the IRB of Record, but only processes submissions on behalf of another review, you would set this to “No”. You would also set this to “No” if your system is using more than one IRB and the IRB that is processing this submission is not the board of record. Note that any study that comes through this IRB that has the IRB of Record flag set to “No”, the system will exclude those studies from Continuing Review reporting. That study will not receive continuing review tasks or notifications, and will not appear Continuing Review Monitor.

IRB Initial Approval – If you are processing an Initial Review, you can enter in the IRB Initial Approval Date here. Otherwise, this date field will be locked down and will display the Initial Review Approval Date.

Review Cycle – This is a configurable drop-down list of review cycles. Each cycle has a month-period associated that will update the IRB Expiration date based on the Submission Approval date.

IRB Expiration Date – You can manually set the expiration date, or, based on the Submission Approval date and the Review Cycle, you can calculate the date. A new property has been added which allows users with board administration access to modify the way the system calculates the study expiration date. When this property is set to "No" the system calculates the study expiration date based on the study date and the selected review cycle and sets the expiration date for a day before the study expires.

When this property is set to "Yes" the system will set the study expiration date to the exact date of the expiration of the study, and the study will expire right when the next date begins.

Note: This functionality will only take effect if the auto expiration function is activated within your system.

Clicking the Calculate Date button when there is a Submission Approval date and an option selected in the Review Cycle drop down list will calculate the IRB Expiration date. This date bases itself off the Review Cycle, minus one day.

If you are processing a submission that is not the Initial Review or the Continuing Review, the Review Cycle and the IRB Expiration date will be locked down. This information can be changed if necessary, through the Study Summary Profile. 

Last Continuing Review Approved – This field will be empty for a study that has not gone through a continuing review. For Initial Reviews, this field will be empty. Once a study has had one continuing review approval, this date will populate for future submissions with the last date the continuing review was approved for the study.

Continuing Review Due –You can enter the Continuing Review Due date here. The system is setup to track Continuing Review Reporting information on open/active studies. Depending on your system settings, the system will send Continuing Review Notifications to the study based on the IRB Expiration Date, or the Continuing Review Due date.

The remaining fields are available to set when that information is relevant to the study.

Study Closure – If you are processing a submission that warrants that the study be closed, enter the Study Closure date here.

Temporary Closed – If you need to temporarily close the study, set the flag to “Yes”.

Temporary Closure Start –You can enter the Temporary Closure date here.

Temporary Closure End – Enter the Temporary Closure end date here.

Exempt – Use this field to categorize this project as Exempt from further review by the current Review Board.

Subjects Approved – Use this field to set number of allowable subjects and/or controls in the Subjects Approved. If you are also using Subject Management, the number of approved subjects in this field will control the number of subjects the study can enroll.

Termination – If the Board terminates the project, the date of termination is entered here.

Annual IRB/SRB review notification type sent based off of Study Status

With the implementation of the new common rule, “Common Rule – Effective January 2019”, different notifications can be configured to remind users about study expirations and renewals. The option to choose the new common rule is available in the Outcome tab in the Submission Processing Queue under “Select Categories for Study”.

A new property has been added to setup the new common rule and activates the function to send a type of continuing review notification based on study status.

Email with Home Screen Task and Continuing Review – This will send an email notification regarding the upcoming expiration status of the study to the user’s default email address for notifications and will receive a task on their home screen as well as a request for a Continuing Review Submission.

Email with Home Screen Task Notification – This will send an email notification regarding the upcoming expiration status of the study to the user’s default email address for notifications and will receive a task on their home screen.

Email Notification Only – This will send an email notification regarding the upcoming expiration status of the study.

No Notification – This will not send an email notification to the user.

When the property is set to “Yes” and the IRB or SRB members go to the Outcome tab, they will have the option to choose the new Common Rule, under “Select Categories for Study:” and can change the Type of Review Notification from the associated Study Status. If the user selects Common Rule – Effective 2019, then the option, “Please Select the Type of Review Notification that Must be Sent:” appears but will only be Read-Only.

The way to change the Type of Review Notification received is to change the Study Status. Below are two examples of different Study Statuses and different Type of Review Notification associations.  

Study Status is “Open” and Type of Review Notification is “Email with Home Screen Task and Continuing Review”.

Study Status is “Closed to Accrual with follow-up” and Type of Review Notification is “No Notification”.

After entering in the appropriate Outcome information, click the Save the Submission Outcome button. Any changes you make to the study will reflect immediately however, the submission will not complete or return to the study until you indicate in the Submission Complete tab that you are finished with the submission.

Outcome Letter

This tab will allow you to create an Outcome Letter to send to the Principal Investigator and study team.

Select the Notification Letter type from the drop-down list. The outcome letters associated to this list are configured within the Review Board Administration. Please see the Review Board Administration Manual for more details.

Letter Generation

To create a letter, begin by selecting a template from the Notification Letter drop down list. After the template is selected click the Create Letter button.

The letter templates are created in Review Board Administration – System Setup – Setup Outcome Letter Templates. You can have any number of templates defined as needed.

After clicking the create button, a screen will be displayed with an embedded text editor.  The text editor will contain the modifiable version of your letter.  To the left of the screen is the submission information (Reference Number, Submission Type, IRB Number, Study Number and Assigned Analyst).

Note: If you are using a browser other than IE, you may need to use the download and upload button that will be available when you Edit/View the letter or signoff 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 require signature signoffs for this letter, select “Yes” under Does this letter 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”. 

You may also choose to share the Outcome Letter with other boards that will be reviewing this submission. Select “Yes” to the Share this letter with other Boards option. This will expand to a list of available review boards in your system. You can choose any number of boards or select to share with “All”. When this submission is sent to another board, the letter will be accessible when processing the submission.

Make changes to the content of the letter as necessary.

While you are working on the letter, you may expand the embedded editor by clicking on the Expand Word Window button.

This will expand the editor, allowing you more room while working on the letter. Click the Minimize Word Window button to return to the normal view.

You may also insert templates by selecting the Insert Template Language button.

A list of template language will appear.  This list is also pre-defined in Review Board Configurations – System Setup – Setup Template Language.  To select the template, click on the icon next to it.  After all necessary revisions/additions are made select the Save Letter Changes button.

After creating the letter, a record will populate on the Outcome Letter page. At this point, the letter can be deleted, sent to the study, or edited. Some of the columns in the Outcome Letter table will change depending on the status of the letter.

Delete/Void – You can delete a letter as long as it has not been sent. Once a letter is sent, it can be made void. 

Send – The Outcome Letter can only be sent if there are no tasks pending for the letter. When a letter is available to be sent, the button appears selectable. Once a letter is sent, you have the option to Resend the letter. The button will change from a selectable Send, to a selectable Resend. If the letter is pending signoffs, the button will gray out. You will not be able to send the letter until the signatures are collected.

Edit/View – The icon in this column will remain the same, however, depending on whether or not the letter has generated into a PDF document, you may or may not be able to edit the letter when you open it.

Signature Required – This column will display either “Yes” or “No” to indicate whether or not this letter requires signatures before it can be sent. 

Status – The status of the letter will display in this column. Available statuses:

‘Waiting to be sent’, which means that the letter can be sent;

‘Waiting to be Routed for Signoff’, you cannot send the letter until signatures have been collected. If the letter status is this, an icon will populate in the Route Signoff column;

‘Routing in progress’, this means that the letter has been routed for signoff and cannot be sent until the signatures have been collected;

‘Denied in Routing’ means that the person assigned to sign the letter denied the letter. You still cannot send the letter, you must reroute the letter for signatures;

‘Routing Complete Waiting to be sent’ means that the signature was collected, and you can send the letter.

Route Signoff – This column will populate with an icon if you indicated for the letter that a signature is required on the letter before it can be sent. Clicking this icon will display a new page, allowing you to either select the person or persons needed to sign the letter, or if you have already done this, clicking the icon will display who you have routed the letter to and what their signature status is.

Copy – You can copy a letter if you need to resend a letter or make changes to an existing letter. Often this is used if the signature was denied on a letter and you need to make changes and reroute the letter. Clicking this icon will copy the letter contents and a new letter record will be created on the page. After the letter is copied, you can edit the new letter and route that letter for signatures.

Delete/Void Letters

You can delete an Outcome Letter, but only if it has not been sent. After a letter is sent, you can void the letter. To delete the letter, click the checkbox in this column then click the Delete Letter(s) button. A confirmation popup will open within the browser window asking if you are sure you would like to delete the letter. Click OK to confirm.

To void a letter, it must first have been sent. The checkbox in this column will change to a Void button. When you click this button, the system will ask if you are sure you want to void the letter. Click OK.

The letter will be voided. The Status column will update to read that the letter has been voided.

If you open the letter to view, the PDF document will be stamped with VOID on all pages. 

After voiding the letter, you would want to Re-send it to the study personnel.

Sending a Letter

The send column will populate with a button allowing you to send the letter. If the letter is being routed for signatures, the button will appear grayed out and you will not be able to send the letter, until the signatures have been completed.

When you click the Send button, a new page will open. This page allows you to enter a Letter Title, select the Outcome Letter recipients and add additional recipients if they are not listed on the page.

At the top of the page, study and submission specific information is listed, Submission Type, IRB Number, Study Title, and Reference Number. Letter Title is an editable field, allowing you to type in the desired title for the letter.

Below this information are tables containing lists of users in iRIS. These users are broken into different groups. Listed are the Study Personnel, Sponsor Contacts and members of different review board committees. Depending on property settings, the users listed in these groups may or may not be pre-selected. Any user with a checkbox next to their name indicates they will be an Outcome Letter recipient when you send the letter.

You can add additional recipients to receive the Outcome Letter by choosing to add a recipient from iRIS or you can choose to enter in an email address.

Click Add recipient from directory to add an iRIS user to the letter.

This will open the Search User Directory page, allowing you to search for the desired iRIS user. When you find the user to add, click the Select User icon.

The user will populate in the Additional Recipients table with the checkbox pre-selected. You can add an Association to the user by entering that information into the Association column.

Click the Add recipient manually button to enter in an email address for a person who does not have an account in iRIS.

A new page will open, allowing you to click the Add a Recipient button to add a non-iRIS recipient.

Clicking the Add a Recipient will add a row to the page. You can type in the Name and E-mail address. You can have as many non-iRIS recipients as needed. When you are finished, click the Save and Return button.

The non-iRIS recipients will be listed in Additional Recipients. The Association field is a required field; you will not be able to send the letter without information in this field.

If you do not need to send the letter to any Additional Recipients, you cannot delete the recipient. You will need to uncheck the checkbox in the Send if Checked column before you save this page.

When you are ready to send the letter to the selected recipients, click the Send to selected recipients button on the top right of the page.

Once the letter is sent, the system will generate a PDF from the Word document and attach that PDF to the Outcome Letter notification as defined in Review Board Administration. You will be returned to the Outcome Letter tab.

Routing for Signatures

After saving the letter, if you indicate signatures are required on the letter, you will be directed to the Submission Letter Signoff Routing List page. 

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

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

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

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

Order Number – Specifies who will receive the signoff task first.

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 current logged in user.  An icon will populate in this column for each personnel.  If you are looking at this page and are selected as the signoff personnel, the icon next to your name will darken and you will be able to signoff 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 included in the letter.

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

Date Received – Date user receives the letter for signature.

Date Completed – Date the user applies electronic signature.

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

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

Once all selections are made, click “Yes” in the field Have you completed your selection of required signatures? This will send the Outcome Letter Signoff tasks to the selected users when you save the signoff list.

Click the Save Signoff List button.

At this point, the system will send the signoff tasks and the outcome letter will convert from a Word document to a PDF.

Click the Back button to navigate back to the Letter page. The Outcome Letter now appears in the window as an un-editable PDF document.

Any user assigned to sign off on an Outcome Letter will receive a homepage task.

Opening the Signoff task will open the letter in a new page. If the user signing the letter had been given rights to edit the letter, the letter on this page would display as an editable document within an embedded browser. The example above displays the PDF letter, meaning this user was not granted the ability to modify the letter before approving or denying the letter.

To the left of the letter, study and submission information is listed. There is a drop-down list that the user can use to select either Approve or Deny.

Comments can also be added to the letter on this page.

Denying the Outcome Letter

To deny the letter, the user simply chooses the Deny option from the drop-down list. When this option is chosen, a button will populate below the dropdown list allowing the user to edit the letter with any suggested changes.

When the button Click here to revise a copy of the letter with your suggestions is clicked, the page refreshes to display a copy of the letter in an embedded Word editor. After any changes are made, you would click the Save Letter Changes button.

At the point where the user denies and saves the letter, the system will update the letter record in the Outcome tab, in the Submission Processing screens. The Status updates to reflect the signature was denied and the letter cannot be sent.

Click the Route Signoff button.

Because the letter was denied, any other signoff tasks have been cancelled and the Submission Letter Signoff Routing List page is locked down. There will display a Word icon in the Approved column for the user that denied the letter. You can click on this to view any suggested changes.

A new page will open. The modified letter is displayed in the embedded Word editor. You can view the changes and make any other necessary modifications. Once necessary changes are made, click the Copy Revised Letter.

A copy of the letter will need to be made, because the original letter has been denied and locked down for version control. Creating a copy will create a new Outcome Letter record that you can also route for signature and send to the study. The screenshot bellow shows two Outcome Letter records, Version 1 and Version 2. Version 1 has been denied approval and is thus locked down. It cannot be sent, and it cannot be modified. You can, however, delete the Outcome Letter. Version 2 of the Outcome Letter is in an editable state and can be routed for signoff or it can be sent to the study personnel.

Approving the Outcome Letter

To approve an Outcome Letter, select the Approve option from the dropdown list. When you select this option, a User ID and Password field will populate on the page. Before you can save the Approval, you must supply your User ID and password and then click the Save Letter Review button.

When the approval signoff is completed, the letter will generate a PDF. If the signoff task was flagged to Include Signature and the Electronic Signature merge code has been inserted into the Outcome Letter template, the signature information will populate in the Outcome Letter, similar to the screenshot above.

At this point, the Analyst assigned to the submission would receive a notification from the system regarding the completion of the Outcome Letter Signoffs.

Returning to the Outcome tab in the Submission Processing screens, the letter record will update indicating that signature routing is complete in the Status column.

At this point, the Send icon will be selectable, allowing you to send the letter to the study personnel.

You can click on the icon in the Route Signoff column to obtain any additional details about the signoffs collected for the Outcome letter.

The Submission Letter Signoff Routing List page will be opened. Since the letter signoffs have been completed, this page will be locked down from editing. And comments added by any of the assigned users can be viewed in the Comments column.

Copy a Letter

Letters can be copied to create a new Outcome Letter, based on a previously generated letter. This is generally done in the case a letter was routed for signoffs and was denied in that process, or if a letter had been generated and sent but was later voided for an error. You could copy the existing letter and make any changes, instead of re-creating the letter from scratch.

To copy the letter, click the Copy button. 

A new version of the letter will be created and will display in the Outcome Letter table. You will be able to Send the letter, Edit the letter and route if for signoff.

Submission Complete

The purpose of this last tab in the Submission Processing Screens is to indicate to the system, that you are finished processing the submission from the review board, whether that be for Pre-Review, Full Board, Expedited, Exempt or Process Administratively. Until you come to this tab and check off that the submission is complete, the submission record will remain in the Assigned tab in the Submissions queue. It will not return to the study for any corrections required by the review board, it will not be completely Approved, even if the meeting date assigned to the submission has passed. You must indicate that the submission is complete on this page. Doing so will complete this round of the submission, moving the submission record from the Assigned tab to the Completed tab. If you indicated that Pre-Review Changes or Post-Review Changes are required, the system will generate a response form, attach the submission and components and return to the study.

The Submission Complete tab is broken up in to three sections: Review Complete, Review Outcome Letters, and Display Submission Components.

A field called “Restoring Context on Response” has been added to Submission Complete screen. If the submission will be sent back to the study team, the “Restore context on response” can be checked if the board member wishes to retain the assigned reviewers. Restoring the context of a response can be applied to each review process.

Review Complete

Listed in this table is the submission outcome information, Review Outcome, Additional Information Required and Study Status. You will not be able to complete a submission if the Review Outcome has not been set, unless the Review Process in the Pre-Review Screening tab is set to Pre-review Changes Requested.

Also listed in this table is the Submission processing complete checkbox. This is the indicator that the review board is finished with processing the submission and this is the flag that will move the submission from the Assigned tab to the Completed tab.        

Do not set this indicator until you are ready to complete the submission. Once you click this checkbox and save the page, the system will take action on the submission based on the Review Process and the Outcome. If this submission has been marked to return to the study for changes, the system will generate a response form to return to the study. The submission will lock down for editing when the submission is complete, meaning you can no longer change the Outcome information, generate letters, assign reviewers or create stipulations. Completing the submission is the last step in the Review Process and should not be completed until all elements of the submission are gathered and entered into the submission screens.

If you do mark the submission as complete before it was necessary, you may reset the completion in the General Information tab.

If, however, the submission has been returned to the study for corrections, you will not be able to undo the completion due to the study having the submission. In this case, you would need to request the study submit the new round to the review board for processing and at that time you could enter any additional details, however, that information would be associated to the new round of the submission.

Review Outcome Letters

Also listed in this tab is a summary of any Outcome Letters that have been generated.

You can Edit a letter that has not yet been sent or view any letter that has been locked down from this area. The Outcome Letter table serves as a reminder to generate and send any necessary letters, before completing the submission.

Display Submission Components Status

The components of the submission are listed on this page as well. This will allow you the opportunity to approve documents before completing the submission, if the documents have not yet been approved in the Submission Components tab prior to completing the submission.

The functionality of the Submission Components table is the same as described in the Submission Components portion of this document. See that section for more details.