Create Renewal with 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 with amendment action allows the investigator to submit a renewal request and make changes to the research protocol at the same time. This can occur more frequently than once per year, but must occur once per year for all protocols requiring IRB review/approval.
Table 256 Protocol Document, Protocol Actions Page, Request an Action Section, Create Renewal with Amendment – Action Attributes
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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 – Open to Enrollment", "Active – Closed to Enrollment", "Active – Data Analysis Only", or "Exempt" 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 946 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Renewal with Amendment Layout
Table 257 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Renewal with Amendment Field Descriptions
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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 |
|
Amend |
Select the portion(s) of the Protocol you intend to
amend. Click within the checkbox |
|
|
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 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. 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. It is possible to have more than one amendment /renewal outstanding at the same time, but to avoid data collisions; KC does not allow two amendments/renewals of the same section of the protocol to be outstanding at the same time. Once any amendment/renewal protocol is approved, all outstanding amendments and renewals to the same protocol will be updated automatically by the system to reflect the changes to the original protocol made by the approved amendment/renewal 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
saved, click the green arrow 
symbol to view full text in a
separate browser window.
