Return to PI

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Return to PI

This action allows the IRB Administrator to return an IRB protocol to the investigator for corrections prior to a formal IRB committee review. The Return to PI action is similar in nature to the Specific Minor Revisions and Substantive Revisions Required with the exception that it does not need committee decision to be recorded prior to sending back the protocol for corrections. This action can be used in institutions where a pre-review of the protocol is conducted by the IRB office and/or reviewers and the decision has been made to have the researcher resubmit the protocol with corrections. Review comments can be entered in the protocol to inform the researchers what they need to change.

Table 405 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Return to PI 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 Assign to Committee and Schedule action must have been performed The protocol status must be in Submitted to IRB The submission status can be in any state
Protocol state after action	After the action is performed The protocol status changes to Return to PI The submission status changes to Returned to PI

Figure 1186 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Return to PI Action Layout

Table 406 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Return to PI – Field descriptions

Field	Description
Comments	To enter textual information to describe this action, 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”.