Create Renewal without Amendment

 

 

This function is not currently in use within KC-IRB.

 

Table 309 Protocol Document, Protocol Actions Page, Request an Action Section, Create Renewal without Amendment Action – Action Attributes

  Action attributes

Description

Who can perform action

Investigators can initiate this action.

Protocol state prior to action

Prior to the action being performed, the protocol must be in one of the following states:

  • Active - Open to Enrollment
  • Active Closed to Enrollment
  • Active - Data Analysis Only
  • Expired
  • Administratively Closed
  • Closed by Investigator
  • Suspended by Investigator
  • Suspended by IRB

The submission status can be in any state.

 

 

Protocol state after action

After the action is performed

 

The protocol status changes to Renewal in Progress

The submission status is empty.

 

 

 

Figure 688 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Create Renewal without Amendment Layout

 

Table 310 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection – Create Renewal without Amendment Description

Button

Description

Summary

Enter text that summarizes the need for the renewal.  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.

Click the create button to request a continuation to work on a previously-approved project. The acceptance of the renewal by the IRB committee will generally extend the expiration date (default in KC is to extend by 1 year). You will not be able to modify data elements in the Protocol document. Upon create action for the renewal without amendment, the system creates a new protocol document with the R00X suffix.