Specific Minor Revisions (SMR)

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Specific Minor Revisions (SMR)

This action allows the IRB Administrator to record a Specific Minor Revisions action for an IRB protocol following a full committee review. The SMR determination indicates that an investigator needs to make changes to a protocol to secure IRB approval. These changes must be specific and minor, such that an evaluation of risks that might be greater than minimal is not needed. Some institutions also call the SMR a conditional approval. Within the protocol actions, the SMR action

is available only after the Record Committee Action has been performed on the protocol with a motion type of Specific Minor Revisions. The changes requested by the IRB office and/or reviewers are communicated to the researcher through review comments.

The system does not allow specific minor revisions action unless there is at least one review comment.

Table 410 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Specific Minor Revisions – 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 Record Committee Decision must have been performed with a motion type selection of “Specific Minor Revisions”. The protocol status must be Submitted to IRB. The submission status must be In agenda.
Protocol state after action	After the action is performed the protocol state changes as follows The protocol status changes to Specific Minor Revisions Required The submission status changes to Specific Minor Revisions Requested..

Figure 1189 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Specific Minor Revisions Action Layout

Table 411 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Specific Minor Revisions Action 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 saving, 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”.