Modify Amendment Sections

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Modify Amendment Sections

This action allows investigators to modify their selection of protocol sections that they want to amend. This action is allowed for Amendment and Renewal with Amendment submissions. The system allows investigators to select the sections they want to amend when initiating an amendment or renewal with amendment. Once the amendment/renewal submission is in progress the only way to add or remove the sections selected for amendment is through the Modify Amendment Sections action.

Table 330 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Amendment Sections – Action Attributes

Action attributes	Description
Who can perform action	Principal Investigator, Co-PI Student/Fellow/Resident, Study Managers/Coordinator, and Aggregator can perform this action.
Protocol state prior to action	Prior to the action being performed, the protocol must be in one of the following states: Amendment in Progress Renewal in Progress
Protocol state after action	After the action is performed: The protocol Status does not change The Submission Status does not change

Figure 701 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Amendment Sections Action Layout

Table 331 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Amendment Sections - Field Descriptions

Field	Description
Amendment Summary	To modify the summary of the reason for the amendment/ renewal with amendment, click within the text box and type or paste 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.
Amend	Modify previously selected protocol sections and/or Questionnaires. De-select protocol sections selected when the amendment/renewal was initiated OR select additional protocol sections to amend.
	Click the update button to apply the change in selection of protocol sections to amend. You are then able to make changes to the selected sections within the amendment or renewal submission.