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 and Renewal with Amendments protocols. The system allows investigators to select the sections they want to amend when initiating an amendment or renewal with amendment. Once the amendment/renewal protocol is in progress the only way to add or remove the sections selected for amendment is through the Modify Amendment Sections.
Table 380 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Amendment Sections – Action Attributes
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Action attributes |
Description |
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Who can perform action |
Investigators can perform 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 Amendment in Progress or Renewal in Progress
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Protocol state after action |
After the action is performed
The protocol status does not change The submission status does not change |
Figure 1172 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Amendment Sections Action Layout
Table 381 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Modify Amendment Sections - Field Descriptions
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Field |
Description |
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Amendment Summary |
Modify text that summarizes the reason for the creation
of an amendment or renewal with amendment to the Protocol document.
Click within the text box (or press the tab |
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Amend |
Modify previously selected protocol sections. De-select protocol sections selected when the amendment/renewal was initiated OR select additional protocol sections to amend. |
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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 or 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.