Substantive Revisions Required
This action allows the IRB Administrator to record a Substantive Revisions Required action for an IRB protocol following a full committee review. This is a determination made at a convened/full board IRB meeting, where the IRB feels that there are changes needed or there are unanswered questions related to greater-than-minimal risks in a research protocol. The investigator must make changes/provide clarifications and submit for further review at a subsequent convened/full board IRB meeting. Some institutions call this tabling a Protocol. This action only appears after the Record Committee Action has been performed on the protocol with a motion type of Substantive Revisions Required. The changes requested by the IRB office and/or reviewers are communicated to the researcher through review comments.
|
|
The system does not allow substantive revisions required action unless there is at least one review comment. |
Table 364 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Substantive Revisions Required – 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 “Substantive Revisions Required”. 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 Substantive Revisions Required The submission status changes to Substantive Revisions Requested. |
Figure 720 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Substantive Revisions Required Action Layout
Table 365 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Substantive Revisions Required – Field Descriptions
|
Field |
Description |
|
Comments |
To enter textual information to describe this action,
click within the text box (or press the tab |
|
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 |
|
Review Comments |
|
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.
