Reminder to IRB Notifications

 

The purpose of Reminder to IRB notifications is to remind the researcher to take action on the protocol returned to them for revisions either through (SMR or SRR actions) .The Batch Correspondence functionality for Reminder to IRB notifications depends on the following three components within the Kuali Coeus application

Ø Protocol Action date, the Actual Action date (date protocol action was taken) and Current date.

Ø Days since Committee Action and Final action setup for Reminder to IRB notifications within Maintenance/Compliance –IRB/Batch Correspondence

Ø Date range setup for Protocol Renewal Reminders within Committee/Actions/Batch Correspondence

 

Institutions typically set up reminders to go out to researchers in frequent intervals after SMR/SRR action has been taken in the protocol.

1.  The Kuali Coeus application determines when to send reminder letters based on the days specified within Days since Committee Action within Maintenance/Compliance –IRB/Batch Correspondence/Reminder to IRB Notifications.

Note – Out of the box, KC provides a set up such that a reminder letter would go out 15 days and 30 days after committee action has been taken. If needed institutions can also define a final action to be taken at a certain number of days past the committee action.

 

2.  The protocols that are to be selected for sending reminder to IRB notifications are based on the date range provided within the Committee/Actions/Batch Correspondence and the actual action date on which the SMR/SRR action was taken.

 

 

 

A typical use case for the IRB office might be to run Batch Correspondence for Reminder to IRB Notifications at periodic intervals of time. The following actions would take place

§ User with administrative privileges uses the “View Active” action to open the IRB Committee application and go to the Batch Correspondence tab

§ User selects the Batch Type = Reminder to IRB Notifications and enters a date range within Protocol Expiration / Committee Action within which they want to check for any protocols that had SMR/SRR actions taken on them.

§ User clicks on submit to run the Batch Correspondence program.

§ The system checks for any protocols that have SMR/SRR actions taken on them on a date that falls within the within the date range specified by the user and selects these protocols as possible candidates for Batch Correspondence Reminder to IRB notifications.

§ The system finds the difference in days between the current date and the protocol action date (recorded within the protocol).

§ This difference in days is compared against the “Days since Committee Action” within Maintenance/Compliance –IRB/Batch Correspondence/Reminder to IRB Notifications, to decide which reminder letter to send.

 

For e.g. If the set up within Maintenance/Compliance –IRB/Batch Correspondence/Reminder to IRB Notifications is the following:

         

The system will subtract the protocol action date from the current date to determine the number of days

          since Committee action.

 

This result is then compared against 15 and 30 (days specified in the Days since Committee

Action column)

 

If result is greater than/equal to 15, the Reminder to IRB Notification #1 should generate

If result is greater than/equal to 30, the Reminder to IRB Notification #2 should generate.

Note - If any action is specified in the “Take this action” column, that action will be automatically taken on

the protocol when the result is greater than/equal to 30.

 

§ Once the system makes the determination about what action (reminder to IRB Notifications/Final Action) to take on the protocol, the results are recorded within Batch Correspondence History within Committee/Actions/Batch Correspondence.