Submit for Review

Submission Type

Required.  Select one of the following options as appropriate:  Initial Protocol Application for Approval, Continuing Review/Continuation without Amendment, Amendment, Response to Previous IRB Notification, or Continuing Review/Continuation with Amendment.  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 Eligibility Exception, Training Certification, Unanticipated Problems, DSMB Report, Annual Report, Annual Scheduled by IRB, Contingent/Conditional Approval/Deferred Approval/Non-Approval, Eligibility Exceptions/Protocol Deviations, AE/UADE, Compliant, Deviation, Protocol-related COI Report, or Self report for Noncompliance.  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.

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.

Submission Review Type

Select one of the following:  Full, Expedited, Exempt, Limited/Single Use, IRB Review not required, Response, or FYI 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. Upon selection of expedited or exempt review types, the system displays checklists of selection values pertaining to the review type. It is mandatory to select a value from the checklists prior to protocol submission. The selection values are pre-defined by the implementing institution and further explain why the protocol requires an expedited or an exempt review.

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.

Approve

After recording a vote on a motion to approve, the IRB Administrator records the decision to grant approval, enters the approval date and comments.  Expiration date will be generated based on approval date, but can be modified.  Risk level can be recorded.

Assign Reviewers

Click the desired checkbox for each reviewer you want to select, choose either primary or secondary for each, then click the submit button.

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 and Schedule

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

Close

  Enter comments, review comments and an effective date.

Close Enrollment

This is the IRB Administrator’s reaction to the Researcher’s request to close enrollment of study participants by the PI and it changes the status of the document to Active – Closed for Enrollment.  This action can also be taken by the IRB Administrator without a request from the Researcher.

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 researcher 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 researcher.  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 Renewal with 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.  Changes to the data elements and an extension of the expiration date will result upon approval.

Create Renewal without Amendment

Click the create button.  A renewal (also referred to as a continuation) is a request (usually annually) to continue work on a previously approved project.  A renewal would not include any change in process or information.  It may require some sort of progress report or statement.  The acceptance of the renewal by the IRB committee will generally extend the expiration date (default in KC is to extend by 1 year).  For a renewal without amendment KC will not allow any data elements in the protocol to be modified.

Data Analysis Only

Response to Researcher request for Data Analysis Only, this action indicates that that the human participant portion of the study is complete and only data analysis remains to be completed.  This action can also be taken by the IRB Administrator without a request from the Researcher.

Defer Action

Enter comments pertaining to the reason for deferment, specify an Action Date for the deferment action to become effective, optionally add Review Comments, then click the submit button.

Delete Protocol, Amendment, or Renewal

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

Expedited Approval

IRB Administrator records decision to grant expedited approval. Enters the approval date and comments. Expiration date will be generated based on approval date, but can be modified. Risk level can be recorded.

Expire

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

Grant Exemption

Optionally enter review comments and action comments, modify action date, and add to a meeting agenda to grant an exemption to a previously-submitted Protocol document.

Make Administrative Correction

Type to enter comment text explaining the purpose for the correction, then click the edit button.  Make corrections in the appropriate sections, then select Apply Administrative Correction checkbox and click the submit button.

Manage Review Comments

Enter review comments without performing any additional action on the protocol.

Modify Submission Request

Select different options for Submission Type, Submission Review Type, Billable flag, and Type Qualifier, and then click the submit button.

Notify IRB

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.  This is used by the Researcher to inform the IRB  of an event or new information about the protocol that does not require an amendment.

Request for Data Analysis Only

The Investigator submits a request to notify the Committee that the human participant portion of the study is complete and only data analysis remains to be completed.  A comment is included, and a Protocol Submission record is created.

Request for Suspension

Investigator submits a request to suspend the study. A reason for the suspension is required. Creates protocol submission record.

Request for Termination

Type a reason for the termination request, then click the submit button.

Request to Close

Investigator submits a request to the IRB to close with a comment. Protocol will be submitted to the committee which approved the protocol.

Request to Close Enrollment

Investigator submits a request to close enrollment of participants into the study.  A comment is included.  Creates protocol submission record. The request to close enrollment requires action by IRB Administrator to close enrollment.

Response Approval

IRB Administrator records approval action resulting from a review of the Researcher’s response to a previously-reviewed protocol that required revisions. Enters the approval date, risk level and comments. Expiration date will be generated based on approval date, but can be modified.   Present approval letter for review and to mark final.

Submit for Review

Submit a new protocol/ Amendment/ Renewal/ Response to IRB office for review.  Must select Submission type (New/Amendment/Renewal/Response) and Review type (Full/ Exempt/ Expedited).  Entering committee, schedule and reviewers is optional.  Checklist is required for exempt or expedited. Submission date set to current date.

Suspend

IRB Administrator marks protocol as suspended. Enter comments, reviewer comments and action date. 

Suspend By DSMB

Protocol is suspended by Data Safety Monitoring Board (DSMB).  IRB Administrator enters comments, reviewer comments and action date. 

Terminate

Enter comments that summarize the reason for the termination, 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 Protocol

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.