Create Renewal without Amendment

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Create Renewal without Amendment

Investigator 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 without amendment action allows the investigator to submit a standard renewal request. No changes to the protocol are allowed with this action with the exception of being able to add an attachment.

Table 527 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Renewal without 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 1365 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Create Renewal without Amendment Layout

Table 528 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Renewal without Amendment – Field Descriptions

Button	Description
Summary	Enter text that summarizes the need for the renewal. 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.
	Click the create button to request renewal to work on a previously approved project. The acceptance of the renewal by the IACUC committee will generally extend the expiration date (default in KC is to extend by 1 year). You will not be able to modify data elements in the Protocol document. Upon create action for the renewal without amendment, the system creates 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). Protocol sections within the Renewal without amendment protocol cannot be amended.