The IRB may want to put off, or defer review of a protocol if it does not have enough information to make a decision about a protocol. There are a variety of reasons why this may happen: comments/revision requests have been sent to an investigator but a response was not provided by the time of an IRB meeting; a protocol was tabled at an IRB meeting, put on the agenda for a subsequent meeting, but the investigator was not able to provide revisions by the time of the meeting, so the protocol review was deferred to another subsequent meeting; Using this action, the IRB Administrator can move a protocol that has been submitted for a full committee review to either a different committee or a different schedule for the same committee.
Figure 1161 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Defer Action Layout
Table 363 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Defer Action Field Descriptions
Field |
Description |
Comments |
To enter a description of the rationale behind the defer 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”. |