Create Renewal without Amendment
Approved protocols typically expire after a year since approval. If the investigator wants to renew the IRB 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. This can occur more frequently than once per year, but must occur once per year for all protocols requiring IRB review/approval.
Table 359 Protocol Document, Protocol Actions Page, Request an Action Section, Create Renewal without Amendment Action – Action Attributes
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Action attributes |
Description |
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Who can perform action |
Investigators can initiate this action. |
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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 - Open to Enrollment, Active Closed to Enrollment, Active - Data Analysis Only, Exempt, Expired, Closed Administratively for lack of response, Closed by Investigator, Suspended by Investigator, Suspended by IRB The submission status can be in any state.
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Protocol state after action |
After the action is performed
The protocol status changes to Renewal in Progress The submission status is empty. |
Figure 1159 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Create Renewal without Amendment Layout
Table 360 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Create Renewal without Amendment Description
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Button |
Description |
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Summary |
Enter text that summarizes the need for the
renewal. Click within the text box (or press the tab |
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Click the create button to request a continuation to work on a previously-approved project. The acceptance of the renewal by the IRB 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. |
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