Create Continuation without Amendment
Approved protocols typically expire after a year since approval. If the investigator wants to renew the IACUC approval of a project for 3 years they need to submit a continuation request. The continuation without amendment action allows the investigator to submit a continuation (renewal request for 3 years). The continuation without amendment action allows the investigator to submit a standard continuation request. No changes to the protocol are allowed with this action with the exception of being able to add an attachment.
The system generates a protocol with suffix C00X (where X is 1 for the 1st continuation, 2 for the 2nd continuation and so on).
Table 523 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Continuation without Amendment – Action Attributes
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Action attributes |
Description |
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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 Continuation in Progress The submission status is empty. |
Figure 1363 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Create Continuation without Amendment Layout
Table 524 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Continuation without Amendment – Field Descriptions
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Button |
Description |
|
Summary |
Enter text that summarizes the need for the
continuation. Click within the text box (or press the tab |
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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 continuation without amendment, the system create a continuation protocol with a protocol number derived from (protocol number of the protocol being continued followed by a suffix of C001 for the first continuation, C002 for the second continuation and so on). The protocol sections cannot be updated within a continuation without amendment protocol. |
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.