Protocols - Amending or Renewing a Protocol

Overview

Once a protocol is approved the PI (if granted full access on the protocol) or Admin can initiate an Amendment or Renewal on the protocol if needed.  This will allow you to modify or submit a request for a renewal on the same protocol.  Within these actions you can update information and attach necessary updated documents for review.  

When an Amendment or Renewal is initiated it creates a separate request under the same protocol number and once approved it merges the changes back into the original.  

Configuration Options

There are a number of configuration options listed below that can modify the options available when executing a post approval action on a Protocol.  These are found in the IRB Configuration and IACUC Configuration screens:

• Allow amend and renewal in one action: If you have this option turned on for your protocol type you can create a Renew & Amend action that will require the user to complete the fields in the Amendment and the Renewal template. You can change values in the main protocol in this submission the same way you can in an  Amendment. The Continuing Review and Expiration Dates will be empty when this submission is approved like a Renewal.
• Allow Multiple Pending Amendments: If you turn this option on you can create multiple multiple amendments and submit them for review simultaneously.  You can also create a renewal action and multiple amendment submissions and submit them for review simultaneously. You cannot create more than 1 renewal submission at the same time, and you cannot initiate any action at the same time you have an active Request to Close submission.
  • If this option is not selected only one outstanding action can be done on a given protocol at a time.  If an amendment or renewal is already initiated on a protocol the Amend and Renew action buttons will be greyed out in the existing approved protocol.

Amend

On an approved protocol the Amend button will be available if you need to make a change, modification, or addition to something on the protocol.  This button will only be available to those granted full access to the protocol or an admin can initiate.

Upon clicking Amend you will be required to complete an amendment form which will appear above an editable version of your currently approved protocol. Once you've completed your institution's amendment form you will be able to make changes to the contents of your protocol. 

Once you've completed your changes you can submit the protocol for review/approval. The same actions and functionality is available on a submitted amendment as an initial protocol submission. More information on the submission/review process can be found in the 'Submitting a Protocol' article.

When an amendment is approved the current Continuing Review and Expiration Dates will display in the approval dialog window. They can be updated if appropriate.

Renew

Users with the appropriate access on the protocol can also request a renewal action to extend the approval of the protocol.  Upon clicking the 'Renew' button you will be required to complete a renewal form which will appear above a read only version of your currently approved protocol.

Once you've completed your changes you can submit the protocol for review/approval. The same actions and functionality is available on a submitted amendment as an initial protocol submission. More information on the submission/review process can be found in the 'Submitting a Protocol' article.

When a renewal is approved the Continuing Review and Expiration Dates will be blank since the assumption is they will be changed when the Renewal is approved.

Renew/Amend

If enabled via General Configuration the Renew & Amend option is also available on an approved protocol if a user wants to do both a renewal and an amendment in the same action.  This will initiate a protocol submission with your institution's Renewal and Amendment form above an editable version of your currently approved protocol. Once you've completed your institution's renewal and amendment forms you will be able to make changes to the contents of your protocol. 

Multiple Pending Amendments

If the Allow Multiple Pending Amendments option is turned on when you click on the Amend or Renew & Amend buttons you will be asked to select which sections of the protocol you will be editing in your submission. Each section that appears in your side navigation can be selected. If you select the General Information section the system will automatically include the section that contains the Person list. This is because the person list can be modified by changes to the Principal Investigator field, and vice versus.

If any sections are currently being edited in another Amendment they will not be available to edit in this screen. They will be greyed out with the text "Currently in amendment" displayed next to them.

You can change which sections are available for editing after you've initiated an Amendment.  This may be necessary if additional sections display due to changes in your amendment. To open additional sections click the Add/Remove Sections button in the right hand control bar. The Add/Remove Sections button can also be used to exclude previously selected sections from an Amendment. Please note that if you remove sections from an Amendment, the fields in that section will revert to the previously approved version of the protocol (not the most recently submitted version of the protocol). 

Once you've created your submission each section that is currently editable will appear with a green lightning icon in the left hand navigation.  Each section currently being edited by another Amendment will appear with a grey padlock icon. The grey padlock icon will also appear in the currently approved protocol version so it is clear to users what can be amended at that time.

If you open the versions dropdown your amendment will appear with an Active icon next to it.  The most recent version of all other active Amendment submissions will also have an Active icon to show which versions are currently in development or review.

When an Amendment is approved the changes will be incorporated into the currently approved protocol and all other active amendments, so they immediately represent their changes in the context of the most recently approved protocol. Any sections that are locked by an amendment will be available to edit in new amendments or in currently active amendments once approval is granted.

Changes to Manage Protocols

Once you've taken one of the actions above your new submission will appear in the Manage Protocols screen along with the most recent approved version of your protocol. Once your submission is approved it will no longer appear in the Mange Protocols screen. If it is approved then any changes will be merged into the protocol and can be accessed by opening the current Approved version of your protocol.