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.
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The system does not allow specific minor revisions action unless there is at least one review comment. |
Table 360 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Specific Minor Revisions – Action Attributes
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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 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.
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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 718 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Specific Minor Revisions Action Layout
Table 361 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Specific Minor Revisions Action Field Descriptions
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Field |
Description |
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Comments |
To enter textual information to describe this action,
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 saving, click the green
arrow 
symbol to
view full text in a separate browser window.
