Modify Submission Request

This action allows the IACUC Administrators to change various protocol submission review types and review related specifics for the IACUC protocol. The committee, schedule, reviewer type can be modified from within Modify Submissions Request panel. In addition, the IACUC Administrator can initiate the review determination process to determine whether the IACUC protocol must go through Full committee review or DMR review. The review determinations provided by various committee members appears within this section for the IACUC Administrator to track and manage.   For more information about Review Type Determination, see “Review Type Determination”.

When an IACUC protocol is assigned to an IACUC committee, all committee members by default are allowed to review the protocol. The system assigns a default reviewer type of “committee” to all active committee members. The IACUC Administrator can then override this initial value of “committee” with values of primary/secondary to designate certain committee members as primary or secondary reviewers.

 

Figure 907 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Submission Request (Submitted Protocol, Expedited – Status:  Submitted to IACUC)

 

 

Table 496 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions –Modify Submission Request – Field Descriptions

Field	Description
Committee	Select from a list of committees to assign the protocol. The initial assignment to an IACUC committee through the Assign to Committee action can be changed within Modify Submissions Request.           Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Schedule Date	Select the schedule date for the committee meeting. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Submission Type	Select one of the following options from the list: The list of values change depending on the current state of the protocol. •      Initial Protocol Application for Approval •      Continuing Review/Continuation without Amendment •      Amendment •      Response to Previous IACUC Notification •      Continuing Review/Continuation with Amendment Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Submission Review Type	Select one of the following options from the list:  Full committee member review, Designated Member Review, Administrative Review, FYI, Response and IACUC Review not required. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Billable	To indicate that the sponsor is billed for protocol review, click within the checkbox to select the item.  A check mark appears within the checkbox to indicate the item is selected.  Click within the checkbox again to clear the mark and deselect the item.   Only a person with an IACUC Administrator role has the ability to edit the Billable checkbox selection after saving.     This option may not appear based on your institution’s unique implementation of KC, as it is controlled by an implementation parameter to allow institutions who do not bill, or who track this information in other systems, can remove it from view.
Type Qualifier	Select one of the following from the list:  Modification/Amendments/revision/Significant New Findings, Annual Scheduled by IACUC, Contingent/Conditional Approval/Deferred Approval/Non-Approval, Eligibility Exceptions/Protocol Deviations, AE/UADE, Complaint, Deviation, IACUC Protocol-related COI report, Self-report for Noncompliance, Request for eligibility exception, Training certification, Unanticipated problems and Annual report.
Reviewers	The system defaults each reviewer to a reviewer type of committee. Select from among Primary, Secondary values to override the default selection of “committee” for each reviewer. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.     The list of reviewers becomes visible within Modify Submission Request only when a schedule has been selected.
Review Type Determination	The IACUC Administrator can view the review type determinations provided by all committee members with the Review Type Determination box.
Determination Due Date	Specify the date you want to assign to the IACUC committee members to complete the review determination by.  By default, the field displays the current date.  To change it, click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date.
Send Notification	Click on send notification to send an Action List notification to all committee members to complete their review determination.
Submit	Click the submit button to generate the action request.

Review Determination Process: The review determination process is initiated and managed from within the Modify Submission Request section. The IACUC office must be able to send the protocol to all IACUC committee members in order for them to provide a determination on how the protocol needs to be reviewed and a due date by when the determination is due. Typically the review determination process is initiated for new submission protocols such as initial submission of a new protocol, an amendment, renewal or continuation. Once the review determination has begun, per regulations the IACUC office must allow the committee members till the due date to provide or change their recommended review type. Based on the determination provided by the IACUC committee members the IACUC office might either decide that the protocol needs a full committee review or a designated member review (DMR). Even if one of the IACUC committee members request for a full committee review, the IACUC office must assign the IACUC protocol for a full committee review. Along with the review determination process, in parallel the IACUC office might also initiate a pre-screening process by assigning reviewers to the protocol. The reviewers will be able to review the protocol and provide comments.

The steps for the IACUC Administrator to initiate Review Determination are as follows:

•      Step1 – Select a schedule date within Modify Submission

Upon selecting the schedule all active committee members are displayed with a default member type of committee. The IACUC administrator can assign some of the active committee members primary/secondary roles too.

Figure 908 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Modify Submission Request – Review Determination – Select schedule

 

•      Step 2 – Assign Determination Due Date and send Notification

Specify the date you want to assign to the IACUC committee members to complete the review determination by. Click on the send notification button to notify all active committee members that they have been assigned an IACUC protocol for review determination.

Figure 909 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Modify Submission Request – Review Determination – Assign due date

•      Step 3 – Track Review Type Determination

The IACUC administrators can track review determinations provided by the various IACUC committee members from within the Review Type Determination box within the Modify Submission Request section.

Figure 910 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Modify Submission Request – Review Determination – Track Review Determination