Submit for Review

Submission Type

Required.  Select one of the following options as appropriate:  Initial Protocol Application FYI.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Type Qualifier

Select one of the following options as appropriate:  Request for AE/UADE, Annual scheduled by IACUC,  Annual report, Complaint, Contingent/Conditional Approval, Deferred Approval, Non-approval, Deviation, Eligibility Exceptions/Protocol Deviations, IACUC Protocol related-COI report, Modifications/Amendments/revisions/Significant New findings, Request for eligibility exception, Self-report for non-compliance, Training Certification and Unanticipated problems. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Submission Review Type

Select one of the following:  Administrative Review, Designated Member Review, Full committee review, FYI, Response, IACUC Review not required as appropriate.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

An implementing institute can optionally configure the IACUC application to allow investigators to select committee and schedule during protocol submission. See below for details

Committee

Select the desired option from the list of committee names.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Schedule Date

Select the desired date from the list that is automatically populated with available meeting dates based on your selection in the Committee field.  Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.

Click this button to command the system to submit the review request you selected and notify recipients of the action request, which will appear in their respective action lists.

Delete Protocol, Amendment, or Renewal

Delete Reason

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 this button to record the reason you entered and initiate the deletion action, then click the yes  button to confirm.

Abandon

The investigator can abandon a protocol returned for major or minor revisions. Once abandoned the protocol is considered inactive and no further action can be performed on it.

Administrative Determination

The IACUC administrator can perform various administrative actions on the protocol through this action.

Administrative Approval

The IACUC administrator can perform an administrative approval on an IACUC protocol submitted with a review type of Administrative Review.

Administratively Incomplete

The IACUC administrator can mark an IACUC protocol administratively incomplete and return it to the investigator for corrections.

Administrative Withdrawal

The IACUC administrator can perform an administrative withdrawal on a protocol and the status of the protocol is marked as Administratively Withdrawn. This helps distinguish from a withdrawal action performed by the investigator.

Approve

The IACUC Administrator records the decision to grant approval, enters the approval date and comments for both full committee review and designated member review protocols. Expiration date will be generated based on approval date, but can be modified. 

Assign to Agenda

Click the Assign this protocol to an agenda checkbox, type to enter comments, select an Action Date as desired; optionally add Review comments, then click the submit button.

Assign to Committee

Select a Committee from the dropdown lists, then click the submit button.

Create Amendment

Type to enter text in Amendment Summary;  select appropriate checkbox(es) for the portion of the Protocol document in need of amendment in Amend;  then click the create button.  A new Protocol document is created and you are taken to the selected portion.  An amendment is a request by the investigator to make a change to a previously approved protocol.  This change may be procedural or informational.  Probably the most common amendment is a change to the personnel working on the project. For an amendment KC will allow changes to the data elements in the protocol in specific sections identified by the investigator.  It is possible to have more than one amendment outstanding at the same time, but to avoid data collisions KC does not allow two amendments of the same section of the protocol to be outstanding at the same time.

Create Continuation with Amendment

The continuation with amendment action renews the protocol by 3 years from the date of approval. Type to enter text in Amendment Summary;  select appropriate checkbox(es) for the portion of the Protocol document in need of amendment in Amend;  then click the create button.  A new Protocol document is created and you are taken to the selected portion. 

Create Continuation without Amendment

A continuation without amendment is a request to continue work on a previously approved project for another 3 years.  Click the create button.  A continuation without amendment would not include any change in process or information.  The acceptance of the continuation without amendment will generally extend the expiration date by 3 years.  For a continuation without amendment KC will not allow any data elements in the protocol to be modified.

Create Renewal with Amendment

The renewal with amendment action renews the protocol by a year from the date of approval. Type to enter text in Amendment Summary;  select appropriate checkbox(es) for the portion of the Protocol document in need of amendment in Amend;  then click the create button.  A new Protocol document is created and you are taken to the selected portion. 

Create Renewal without Amendment

A renewal without amendment is a request to continue work on a previously approved project for another year.  Click the create button.  A renewal without amendment would not include any change in process or information.  The acceptance of the renewal without amendment will generally extend the expiration date by a year.  For a continuation without amendment KC will not allow any data elements in the protocol to be modified.

Deactivate

The IACUC administrator can deactivate a protocol upon request to deactivate by the investigator.

Delete Protocol, Amendment, Continuation or Renewal

When the Protocol document has never been submitted, this allows you to delete it from the system.

Disapprove

The Disapprove action can be performed after a full committee review of the IACUC protocol.

Expire

Enter comments that summarize the reason for the expiration, and then select an action date for the expiration to become effective.

Hold

The IACUC administrator can put the work on an approved IACUC protocol on hold using the Hold action.

IACUC Acknowledgement

The IACUC administrator can formally acknowledge the receipt of a Notify IACUC action by the investigator to notify the IACUC of an adverse event, though the IACUC acknowledgement action.

Lift Hold

The IACUC administrator can remove the hold on a previously approved IACUC protocol using the Lift Hold action.

Make Administrative Correction

The IACUC administrator can edit the protocol and make changes using the Administrative Correction action. Type to enter comment text explaining the purpose for the correction and then click the edit button.  Make corrections in the appropriate sections, then select Apply Administrative Correction checkbox and click the submit button.

Manage Review Attachments

The IACUC administrator can manage, control visibility and update review attachments through the Manage Review Attachment action.

Manage Review Comments

The IACUC administrator can manage, control visibility and update review comments through the Manage Review Attachment action.

Modify Amendment Sections

Once the sections to amend through an amendment, continuation or renewal protocol has been chosen, the Modify Amendment Sections allows investigator to add or remove the sections they want to amend.

Modify Submission Request

 The Modify Submission Request is used by the IACUC Administrator to select a schedule for the IACUC protocol, change submission type, initiate the review determination process and assign reviewers.

Notify IACUC

This is used by the Investigator to inform the IACUC of an event or new information about the protocol that does not require an amendment. Select a Submission Type, Submission Review Type (required), and Committee;  browse for and select a file for the File Name field, and type to enter a comment in the Comment field as desired;  then click the submit button.   investigator

Return for Minor Revisions

Following a DMR review or Full committee review the Return for Minor Revisions allows the IACUC administrator to return the IACUC protocol to the investigator for minor changes.

Return for Major Revisions

Following a DMR review or Full committee review the Return for Major Revisions allows the IACUC administrator to return the IACUC protocol to the investigator for major changes.

Record Committee Decision

The IACUC administrator can record the decision of a full committee IACUC review using the Record Committee Decision action. Motions of approve, disapprove, minor revisions and major revisions can be recorded along with the vote counts.

Remove from Agenda

The IACUC administrator can remove an IACUC protocol previously assigned to a schedule agenda from the agenda using this action.

Request to Deactivate

The investigator can request that an IACUC protocol be deactivated through this action.

Return to PI

The IACUC administrator can return a protocol to the investigator for changes prior to committee review using the Return to PI action.

Review not Required

The IACUC administrator can mark an IACUC protocol as not requiring an IACUC review using the Review not Required action.

Request to Lift Hold

The investigator can submit a Request to Lift Hold action for an IACUC protocol that has been placed on hold by the IACUC administrator.

Submit for Review

Submit a new protocol/ Amendment/ Continuation/ Renewal/ Response to IACUC office for review.  Must select Submission type from the following options: Initial Protocol Application, Response to Previous IACUC Notification, Request to Deactivate, Request to Lift Hold, FYI, Amendment, Renewal, Renewal with Amendment and Continuation/Continuing Review.

Suspend

The IACUC Administrator can suspend a protocol using this action. Enter comments, reviewer comments and action date. 

Table

The IACUC Administrator can remove a protocol that has been scheduled to an IACUC meeting for a full committee review using the Table protocol action.

Terminate

Enter comments that summarize the reason for the termination, and then select an action date for the termination to become effective.

Undo Last Action

Type to enter comments that summarize the purpose of undo-ing the last action, then click the submit button.

Withdraw

Type a textual reason for the withdrawal, then click the submit button to withdraw a Protocol application from review.  The PI and any Correspondents are automatically notified.