Data Analysis Only

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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.

Table 361 Protocol Document, Protocol Actions Page, Request an Action Section, Data Analysis Action – Action Attributes

Action attributes	Description
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 must be "Active - Open to Enrollment" or "Active - Closed to Enrollment" The submission status can be in any state.
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

Figure 1160 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Data Analysis Only Layout

Table 362 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Data Analysis Only Field Descriptions

Field	Description
Data Analysis Only
Comments	Enter any comment about changing the protocol status to Data Analysis Only. 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 saved, click the green arrow symbol to view full text in a separate browser window.
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 icon to select, or type in mm/dd/yyyy format to populate the box with the desired date.
Review Comments	For more information, see “Review Comments”.