Create Amendment
An amendment is a request by the researcher to make a change to a previously approved protocol. This can be simple administrative information, such as updating contact information on consent materials, or it can be something related to the study design, such as addition of data collection procedures or a subject cohort. Only protocols in active or exempt state can be amended.
Table 355 Protocol Document, Protocol Actions Page, Request an Action Section, Create Amendment Action – 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 Amendment in Progress The submission status is empty. |
Figure 1157 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Amendment Layout
Table 356 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Create Amendment Field Descriptions
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Field |
Description |
|
Amendment 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 |
|
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. |
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.
