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 Amendments, Renewal with amendments, and Continuation with amendments. The system allows investigators to select the sections they want to amend when initiating an amendment, renewal with amendment or continuation with amendment. Once the amendment/renewal/continuation is in progress the Modify Amendment Sections Action allows the investigator to add or remove sections to be amended.

Table 496 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions –Modify Amendment Sections – Field Descriptions

Action attributes	Description
Who can perform action	Investigators can perform 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 Amendment in Progress, Renewal in Progress or Continuation in Progress
Protocol state after action	After the action is performed The protocol status does not change The submission status does not change

Figure 906 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Modify Amendment Sections

Table 499 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Amendment Sections – Field Descriptions

Field	Description
Amendment Summary	Modify text that summarizes the reason for the creation of an amendment, renewal with amendment or continuation with amendment. 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	Modify previously selected protocol sections. De-select protocol sections selected when the amendment/renewal/continuation was initiated OR select additional protocol sections to amend.
	Click the update button to enforce the change in selection of protocol sections to amend. You are then able to make changes to the selected sections within the protocol within the amendment, renewal or continuation protocol.