Create Renewal with Amendment

You are here:IACUC Protocol > Protocol Actions > Request an Action

Create Renewal with Amendment

Approved protocols typically expire after a year since approval. If the investigator wants to renew the IACUC approval of a project that received approval within the past year, they need to submit a renewal request. The renewal with amendment action allows the investigator to submit a renewal request and make changes to the research protocol at the same time.

Table 476 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Renewal with Amendment – Action Attributes

Action attributes	Description
Who can perform action	Investigators can initiate this action.
Protocol state prior to action	Prior to the action being performed, the protocol must be in the following state: The protocol status must be in one of the following statuses "Active", "Active – On Hold" , "Suspended", "Deactivated”, “Expired", "Administratively deactivated" "Administratively Approved “The submission status can be in any state.
Protocol state after action	After the action is performed The protocol status changes to Renewal in Progress The submission status is empty.

Figure 894 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Renewal with Amendment Layout

Table 477 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Renewal with Amendment – Field Descriptions

Field	Description
Summary	Enter text that summarizes the need for the renewal, what is being amended, and why. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saving, click the green arrow symbol to view full text in a separate browser window.
Amend	Select the portion(s) of the Protocol you intend to amend. 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. You may only make modifications to the components selected; otherwise, the previously-entered data is read-only.
	Click the create button to generate a new Protocol document. Changes to the data elements and an extension of the expiration date will result upon approval. Upon create action for the renewal with amendment, the system create a renewal protocol with a protocol number derived from (protocol number of the protocol being renewed followed by a suffix of R001 for the first renewal, R002 for the second renewal and so on). Once the renewal protocol is approved, the changes are merged with the original protocol and the renewal protocol with the suffix of R00* ceases to exist.