Request for Suspension

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Request for Suspension

This action allows investigator to submit a request to suspend an existing study. The investigator can provide a reason and/or add an attachment to provide further explanation. A protocol is suspended when risk to human subjects has been identified and further investigation is required prior to letting the research continue. This action is typically driven by regulatory obligation and indicates temporary suspension of research activities.

Table 343 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Request for Suspension Action Attributes

Action attributes	Description
Who can perform action	This action can be initiated by investigators.
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, Exempt, The submission status can be in any state.
Protocol state after action	After the action is performed The protocol status does not change. The submission status changes to Pending

Figure 709 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Request for Suspension Layout

Table 344 Protocol Document, Protocol Actions Page, Request an Action Section, Available Action, Request for Suspension – Field Descriptions

Field	Description
Committee	Select the desired Committee name from the list. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
File Name	Click the Browse.. button. In the File Upload dialog box (Windows), use the Look in: dropdown menu to locate the file, click on the file to highlight and select it, then click the Open button. The File Name field now displays the directory, folder path and filename you selected.
Reason	Enter text that describes the rationale behind the action request. 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.
Attachment	Click the Browse button. In the File Upload dialog box (Windows), use the Look in: dropdown menu to locate the file, click on the file to highlight and select it, then click the Open button. The File Name field now displays the directory, folder path and filename you selected.
Description	Enter text that describes the attachment. 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.
Add	Click the add button to add your attachment as a row in the table below, which will become a numbered line item.
	Click the submit button to generate the action request.