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 474 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Continuation 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 Continuation in Progress The submission status is empty. |
Figure 893 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Create Continuation without Amendment Layout
Table 475 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create Continuation without Amendment – Field Descriptions
Button |
Description |
Summary |
Enter text that summarizes the need for the
continuation. Click within the text box (or press the tab |
|
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. |