Suspend By DSMB
This action allows the IRB Administrator to suspend a protocol under direction from the Data Safety Monitoring Board (DSMB). A DSMB evaluates the safety of experimental drugs and devices being used in the research project involving human subjects. The DSMB might determine that risk to human subjects is involved and further investigation is required prior to letting the research continue.
Table 368 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Suspend By DSMB – Action Attributes
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Action attributes |
Description |
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Who can perform action |
IRB Administrators are allowed to 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 can be in one of the following states: 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 Suspended by DSMB. The submission status does not change |
Figure 722 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Suspend By DSMB Layout
Table 369 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Suspend By DSMB Field Descriptions
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Field |
Description |
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Suspend By DSMB | |
|
Comments |
Click within the text box (or press the tab |
|
Action Date |
Specify the date you want this action to become
effective. By default, the field displays the current date. To
change it, click the calendar |
|
Review Comments |
|
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.
