Protocols - IBC Configuration

Overview

As a protocol administrator you can configure the IBC protocol system functionality, notifications, and letter templates to meet your institutional needs.  When enabled the system generated notifications will send to the configured users upon the specified protocol action (i.e. approval, expiration, etc.).  Similarly, the Template Configurations when enabled will allow letter generation for the given action which are accessible in the Activity Log of the protocol. Below is an overview of how to enable, maintain, and customize the available notifications and correspondence templates for IBC in Kuali Research Protocols.

Accessing IBC Configuration

Users assigned to Administrator role(s) have access to IBC Configuration on the Administrator Dashboard.

In the IBC Configuration menu all available IBC system configurations, Notifications, and Templates can be viewed, edited, and enabled for use in the Protocols module. In the top righthand corner of the IBC Configuration you have the below two action buttons available.  If you make any updates to the notifications or templates you will need to click the 'Save' button for the changes to take effect. 

General

You can set some general options for protocols in the General section - below explains each option:

• Allow amend and renewal in one action: gives the option of doing an Amendment and Renewal in the same action via the action button of Renew/Amend. 
• Allow Multiple Pending Amendments: gives the option of submitting multiple Amendments in parallel. To learn about this functionality in detail please read the Protocols - Amending or Renewing article.
• Allow deletion of protocols never submitted: will give a Delete button to end users in initial new protocols that were never submitted and then abandoned so they're removed from the system.  This delete is only available for initial new protocols never submitted and it is not available for Amendments, Renewals, etc.
• Allow duplication of protocols using a template with Active Status or configured to update: If you allow users to duplicate their protocols with the duplicate protocol template function turned off they are only allowed to duplicate protocols using the most recent active protocol template. If you turn on the template update functionality then they can duplicate any protocol using a template equal to or later than the Protocol template version configured here. When they duplicate their protocol the template update message will display before they begin editing their form.  See more information on duplicating protocols here.
• Update the protocol template of protocols with a template version of _ or later: When this is turned on whenever an In Progress document with a Submission Type of New, Amendment, or Renew/Amend is initiated the system will check the Protocol template version the document is linked to and if it's equal to or later than the template version indicated the document will update to use the newest protocol template. The template will NOT update on a returned protocol since we do not want to unexpectedly change the context of ongoing reviews.
• Display message to protocol editor when the protocol template is updated: This configuration allows each institution to write a message that will display to the researcher when the system updates their template. You can point the researcher to the portions of the form that have been updated most recently so they do not feel the need to review their entire protocol looking for new questions.
• Enable Reportable Events:  This will enable the Reportable Events functionality which allows a user to disclose events that occurred within a project that diverged from the approved protocol and requires additional review and approval. This functionality is enabled by default but can be disabled with this configuration.  Please note, if you had Reportable Events enabled with events created but then disable this configuration the Reportable Events tab will no longer be available in the protocol.  However, Admins will still see the indicators in the Event columns available in the Manage Protocol screen which are clickable to view the Reportable Event directly if desired.
• Enable Admin Only Form:  This will enable the Admin Only form template in protocols which is a form for admins to track and maintain protocol data across its lifecycle. Once enabled, the active Admin Only form is turned on immediately and will be added to all new protocols. For this reason customers should start in the SBX environment first to design, enable, and test your form.  See more information in the Admin Only Form article.
• Update Admin Only template on protocols with no Admin Only template or a Template of version _ or later: This configuration option is only available if the 'Enable Admin Only Form' is enabled.  When this is turned on whenever a Submitted for Review or Resubmitted protocol version of any time is opened the system will check the Admin Only template version the document is linked to and if it's equal to or later than the template version indicated in this configuration the document will update to use the newest protocol template.

Permissions

Within Configuration you can set permission settings on who can create/submit protocols in Kuali Research.  If you want to allow all users the ability to create and submit protocols without additional granular provisioning in the system you can check the 'Users should automatically be able to create protocols'.  This will have the system auto-assign the user the ability to create and submit protocols.

If you want to limit the ability to submit protocols to the PI only then you can check the 'Only the Principal Investigator can do the initial submit on protocols' option.  Once checked the 'submit' button will only become available to the principal investigator of the protocol.  Be aware, this is only on the initial submit of the protocol - subsequent resubmit actions can be taken by others listed on the protocol with full access.

And if you want to allow Committee Members the ability to add Action Items in a protocol within an Agenda you can enable 'Committee Members may review and add Action Items (includes all checklists visibility if configured)'.  Please note, this selection will also grant Committee Members view access to any Action Item in the protocol that is marked with visibility of 'Assigned Reviewers', and view access to all checklists if 'Assigned Reviewers may view all checklists' is enabled.

And if you want to allow assigned reviewers the ability to view checklists completed by other reviewers you can enable 'Assigned Reviewers may view all checklists'. This will cause the "Checklists" tab to display for all assigned reviewers.

Lastly, the 'Action Item visibility defaults to include Assigned Reviewers' option when enabled will automatically default the 'Assigned Reviewers' visibility to be selected when creating an Action Item; users may still deselect it if desired.

PDF Watermarking

Within the PDF Watermarking panel you can enable automatic watermark functionality on protocol attachments so that selected attachment types for either an Approved or Unapproved protocol will have a watermark added.  If enabled, this will display text across the PDFs in a protocol when viewing the file and include the desired data configured to include in the watermark text.

When the 'Watermark Attachments' option is checked it will allow you to enable watermarks for the certain Attachment Types.  This Attachment Type list is determined by the configured Attachment Types in your IBC protocol template; specifically those attachments within the Attachment List gadget available in the main protocol only.  All other attachments within other templates using the normal Attachments gadget will be watermarked by default if watermarking is globally enabled but you won't see them in the available list to toggle on/off individually.  

Just below you have the option to then enable watermarks on either approved protocols and/or unapproved protocols. Once the 'Watermark Approved Protocols' or 'Watermark Unapproved Protocols' is selected you will then be given options of data elements to include in the watermark text.

Please note, watermarks will only appear in PDF file types for attachments in the protocol (not admin attachments) and it will only be applied to files in any Attachments gadget. Within the protocol you will see 'With watermark' or 'Without watermark' options available under download for PDF attachments.  This allows you to download the file with the watermark applied or download the original file without the watermark:

Notifications

Within the Notifications panel you can add notification templates for the system generated emails that go to specified recipients on a number of protocol actions.  To setup an email template for a given protocol action click on the name of the action and then either edit the template that displays, or add an additional template.  Below outlines the available Notifications and when they would be triggered:

• Approved: When a protocol is approved.
• Ancillary Reviewer Assigned: When an ancillary reviewer is assigned to a protocol.
• Ancillary Status Changed: When the status of an ancillary review is changed (pending, not approved yet, approved), so that all parties are aware of the current status of the related ancillary review.
• Assigned Reviewer: When a Reviewer is assigned to a protocol.
• Assigned Reviewer Reminder:  Will send a reminder if the reviewer hasn't taken action.
• Closed: When a protocol is Closed.
• Continuing Review Reminder: Will send a renewal reminder X number of days before the protocol Continuing Review Date (the number of 'Days Before' is configurable within the notification itself).
• Protocol Cannot be Approved: When a protocol action is disapproved.
• Expiration Reminder: Will send an expiration reminder X number of days before the protocol Expiration Date (the number of 'Days Before' is configurable within the notification itself).
• Expired: When a protocol Expires.
• Not Human Research Determination: When a protocol has a NHRD 
• Notify PI to Submit: Allows protocol collaborators to contact the PI - if notification enabled the 'Notify PI To Submit' button will be available to users with full access to the protocol.
• Notify PI to Submit Reminder: When a PI was notified the protocol was ready for them to submit a configured number of days ago.
• Assigned Reportable Event Reviewer:   When a Reportable Event is assigned a reviewer.
• Assigned Reportable Event Review Reminder:   When a Reportable Event has been assigned to a reviewer for a configured number of days.
• Reportable Event Requires Follow Up: When a Reportable Event requires a followup before it can be finalized.
• Event Required Followup Reminder: When a Reportable Event has been sent back to the researcher for a configured number of days.
• Reportable Event Resolved: Once a Reportable Event is resolved.
• Submit Reportable Event: When a Reportable Event is initially submitted on a protocol for review.
• Resubmit Reportable Event: When a reportable event is submitted back to the compliance office after the require revisions action is taken.
• Reportable Event Not Reportable: When a Reportable Event is completed as Not Reportable.
• Reportable Event Review Completed:  When a Reportable Event review is completed.
• Request to Close: When the request to close option is chosen in a protocol.
• Resubmitted: When a protocol is resubmitted (addressing revisions).
• Protocol Returned: When the protocol is sent back via the return action.
• Review Completed: When a Reviewer completes their review of the protocol.
• Revisions Required: When a protocol is returned requiring revisions.
• Revisions Required Reminder:  Will send a reminder if revisions haven't been resubmitted by deadline.
• Submitted: When a protocol is submitted for review.
• Suspended: When a protocol is suspended.
• Protocol Suspension Lifted: When a protocol is unsuspended.
• Withdrawn: When a protocol action is withdrawn by the user.

Clicking on the specific notification link will allow you to customize the text and recipients, or setup multiple notification templates in case you want to send different text to different recipients, or send different text at different reminder intervals - more information on editing the notification is in the next section.

The 'Enable Test Mode' option allows an institution to test the system generated notifications without emails going out to live users. If this box is unchecked, the system generated notifications are in PRD mode, meaning they will send to live users. Please note that we always recommend having this box checked in your lower environments (STG and SBX) to prevent notifications from lower environments being sent to live users. If you want to test the system generated notifications by having them sent to a test user, you can indicate the email you would like to direct all notifications to. If this line is blank, no notifications will be sent. When you're done testing and want to enable notifications to work as usual in PRD mode with live users, please remember to uncheck the Enable Test Mode box. 

Editing Notifications

The notifications can be edited to include your own custom content and specify the desired recipients. To open the edit popup window simply click on the Notification Title, and then expand the existing notification template, or add a new one by pressing the + New Notification Template Button.  In the edit dialog you can specify the desired recipients and add more by clicking on the '+ Choose Role' button - this will present a list of available roles you can add as a recipient.

In the Message Template you can edit and customize the notification email Subject and Text to meet your institutional needs.  There are also a number of different formatting options along the top header which gives font and bullet selections.  You can also use the '+Add Placeholder Code' option to insert available fields that will dynamically pull information from the given protocol into the notification.  For example, if you select the Protocol Number it will insert {{PROTOCOL_NUMBER}} into the text of your email which is markup language that will pull the given protocol number from the record and insert it into the email text automatically when sent. Placeholder Codes can be added to the body of the notification, or the subject line.

You can also choose the default Recipients for each notification.  The available recipients are as follows.

• IBC Admins:  Users with the IBC Admin role. Recipients of this role are defined by the Lead Unit on the protocol.
• IBC Triage: Users with the IBC Triage role. Recipients of this role are defined by the Lead Unit on the protocol.
• IBC Department Leads: Users with the IBC Department Leads role. Recipients of this role are defined by the Lead Unit on the protocol.
• Primary Admin:  The Admin Reviewer assigned to the protocol in the Protocol Review Assignment window (via View/Edit Assignments).
• All Protocol Personnel:  All personnel added to a given protocol (including the PI) or listed on the permissions tab.
• Protocol Full Access Personnel: All personnel on the protocol with the Full Access permission.
• Protocol Read Only Personnel: All personnel on the protocol with the Read-Only Permission.
• Administrative Full Access Personnel: All users editable in the Permissions tab with the Full Access permission.
• Administrative Read-Only Personnel: All users editable in the Permissions tab with the Read-Only permission.
• PI:  The specified PI on a protocol. Note: if the Recipients include All Protocol Personnel or Protocol Full Access Personnel then the PI should not be configured as a separate recipient.
• Committee Member:  The Committee Member(s) in the committee to which the protocol is assigned in the Protocol Review Assignment window (via View/Edit Assignments).
• Assigned Reviewer: When used in a review assignment, review assignment reminder, or review complete notification this will send to the individual reviewer that notification applies to. When used in other notifications this will send to all assigned reviewers.
• All Reviewers:  Any Reviewer(s) currently or previously assigned to the protocol.
• All Incomplete Reviewers: All reviewers who have not completed their assigned review from the Assign Reviewers dialog.
• Assigned Ancillary Reviewer: Members of the Ancillary Review being assigned by this notification action.
• All Assigned Ancillary Reviewers: Members of all Ancillary Reviews on the protocol.

When all desired changes have been made to the notification be sure to click the 'Save' button or press X if you want to return to the Configuration page without any changes.

Correspondence Templates

The correspondence templates related to the system generated letters that get created for certain Protocol actions.  These letters are available in the Activity Log tab of the protocol and allow a user to print a more formal notice of a given action - like protocol approval.  

Within the Correspondence Templates panel you can enable or disable the system generated letters. To enable or disable you can use the toggle on the far right - when blue and the switch is in the far right position the template is active.

Clicking on the specific template link will allow you to customize the text of the letter - more information on editing the template is in the next section.

Editing Correspondence Templates

In the Correspondence Template you can edit and customize the content and formatting of the generated letters. There are a number of different formatting options along the top header which gives font, bullet, indent, hyperlink selections.  If you want to add an image to the correspondence letter you can use the image icon (be sure to test the sizing/display).  You can also use the '+Add Placeholder Code' option to insert available fields that will dynamically pull information from the given protocol into the letter.  For example, if you select the Protocol Title it will insert {{PROTOCOL_TITLE}} into the text of the letter which is markup language that will pull the given protocol number from the record and insert it into the letter automatically when generated. Most of the Placeholder Code options are self explanatory but the List of File Name for Protocol Attachments and List of Protocols Attachment Attributes options require a bit more understanding.

• List of File Name for Protocol Attachment - will insert {{ATTACHMENT_FILE_NAMES}} and list all associated files included in the out of the box Attachments List of the protocol template within the generated correspondence letter. Rather than using this option we recommend using the 'List of Protocols Attachment Attributes' explained below.
• List of Protocols Attachment Attributes - Similar to the above this only can be used with the files included in the out of the box Attachments List of the protocol template.  This will insert html similar to the below but will be slightly different depending on the form keys used in your template for attachment fields.  This selection allows you to better control the information about attachments and which attachments will get pulled into the correspondence. The text within the [ ] can be customized to pull in the desired information from the attachments and the types of attachments you want to pull into the correspondence.  The first subset of information within the [ ] allows you to pull in attributes associated with the attachments including the file name, attachment type, and comments associated with the attachment.  If you don't want all of the information to populate in the correspondence you can remove and leave the attributes you desire in the [ ].  The information within the ( ) will pull in the attachment type form key from your template and should not be modified but the subsequent information within the [ ] will list all attachment types available currently in your template.  You can then configure the attachment types within the [ ] that you want to pull into correspondence and remove ones you don't want to populate. 
  {{CUSTOM_ATTACHMENT_LIST: [file1,name1,attachmentType1,comments1]: (attachmentType1)[Consent Material,Study Advertisements,More Types Will Be Listed Here,Other]}}

When the desired changes have been made be sure to click the 'Done' button or 'Cancel' if you want to return to the Configuration page without any changes.

Please also note, when the 'Reportable Event Completed' Correspondence template option is enabled it will allow you to generate/configure correspondence for when a Reportable Event is resolved.  Also, when this correspondence is enabled you will have the option to add a comment upon the Resolve action.  This comment can then be populated in the correspondence if you add the placeholder code 'Event Determination Comment'.  Once the correspondence is generated it will display in the Activity Log which is printable like other correspondence - more information can be found in the Reportable Events article.

Protocol Activity Log

All notification history and generated correspondence is accessible via the Activity Log link on the top of each protocol.  This will show a full history of the actions taken on the protocol including the notifications sent, notification content, recipients, timestamp information, and whether it was sent successfully.  The Activity Log will also house the generated correspondence letters for the protocol (i.e. Approval, Disapproval, Expiration letters) which are accessible by clicking on the 'Correspondence Generated' link. You can expand or collapse the Notification and Update Approval details by using the Expand/Collapse All option in the upper right hand corner of the screen.

Also, if there are Notifications in the Activity Log that did not send successfully and have a failed status you can use 'Retry Failed Notifications' button to attempt to resend the notification:

Review Checklist

The review checklist functionality for Admins and Assigned Reviewers can be enabled in the Review Checklist section of Configuration.  When enabled the Checklist tabs become available to the Admins and/or Assigned Reviewers that allows these users to work thru a created checklist to help in their review of a protocol.  These review checklists are created in the Templates as a Template Type of Check List.  More information on using this functionality can be found in the Protocols - Review Checklists article.

Ancillary Reviewers

Allows you to set up reviewers in your Ancillary Review process - more information on this functionality and how to configure can be found in the Protocols - Ancillary Review article.