Create Amendment

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Create Amendment

An amendment is a request by the investigator to make a change to a previously approved protocol. The user identifies which sections will be modified with the amendment. After selecting the sections to amend, the user can create the amendment protocol. The system generates a protocol with suffix A00X (where X is 1 for the 1st amendment, 2 for the 2^nd amendment and so on). The amendment protocol generated by the system is a copy of the approved protocol with the added provision of investigator being able to update the sections they want to amend.

Table 470 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Create 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","and 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 Amendment in Progress The submission status is empty.

Figure 891 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Amendment Layout

Table 471 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Amendment Field Descriptions

Field	Description
Summary	Enter text that summarizes the reason for the creation of an amendment to the Protocol document. 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.
Amend	Select one or more portions of the Protocol document that you intend to amend
	Click the create button to cause a new Protocol document to be created. You are then able to make changes to the selected portions only. Upon create action for the amendment, the system creates an amendment protocol with a protocol number derived from (protocol number of the protocol being amended followed by a suffix of A001 for the first amendment, A002 for the second amendment and so on). Once the amendment protocol is approved, the changes are merged with the original protocol and the amendment protocol with the suffix of A00* ceases to exist. It is possible to have more than one amendment outstanding at the same time, but to avoid data collisions; KC does not allow two amendments of the same section of the protocol to be outstanding at the same time. Once any amendment to a protocol is approved, all outstanding amendments to the same protocol will be updated automatically by the system to reflect the changes to the original protocol made by the approved amendment protocol.