Data Analysis Only
This action allows the IRB Administrator to react to a Request for Data Analysis by the investigator and change the status on the protocol to reflect that is kept open for Data Analysis only.
The Data Analysis status on a protocol is used in the scenario in which all interactions with human subjects and active data completion have been completed for the research project. However, the data collected is being analyzed and the protocol needs to be kept open and active for that purpose. This prompts the investigator to submit a request to the IRB Administrator to keep the protocol open for Data Analysis.
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Action attributes |
Description |
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Who can perform action |
IRB Administrators are allowed to 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 "Active - Open to Enrollment" or "Active - Closed to Enrollment" The submission status can be in any state. |
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Protocol state after action |
After the action is performed The protocol status changes to Active - Data Analysis Only The submission status changes to Data Analysis Only |
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Field |
Description |
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Data Analysis Only | |
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Comments |
Enter any comment about changing the protocol status to
Data Analysis Only. Click within the text box (or press the
tab |
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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 |
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Review Comments |
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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.
