Submit a Modification

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Modifications are study changes that should be submitted to the IRB for approval prior to implementing except when an immediate change is needed to eliminate or alleviate an apparent hazard or risk to subjects. Study changes without prior IRB approval must be submitted as Reportable New Information. 

Modifications fall into the following categories: those that affect the study team membership, those that affect other parts of the study, or both. The modification follows a similar review process to an IRB study. Use track changes in Word to document changes to relevant submission materials. Track changes is not needed for modifications to the Study Team Member Qualification form (HRP-509).

Example: You wish to change how you’re recruiting participants and you want to add a question to your survey.

Note: Studies determined to be exempt– not including those that have undergone limited IRB review- only need to submit a modification in the following situations: change in Principal Investigator, change in funding, study closure, changes in conflict of interest, and/or proposed changes that might impact the exemption determination (addition of a vulnerable population, change in the way identifiers are recorded so that subjects can be identified, the use of any methods that do not meet the exempt criteria, such as blood draws). See the Investigator Manual for details.

 

Begin a Modification

To begin a modification, navigate to the IRB page by selecting the “IRB tab” at the top left corner of the screen. Next, select the “Active tab” to display approved studies. Then, select the study in which the changes will be made. For study team changes, refer here for additional steps once the modification has been initiated. 

Picture of Continuing Review in the IRB Active Submissions tab

 

Click the “Create Modification/CR” button located in the Next Steps list.

Picture of Next Steps Menu with button to create new modification, continuing review, and administrative review

 

Click the “Modification” radio button to change team membership.

Note: If there is an active Continuing Review, the radio buttons for Continuing Review and Modification and Continuing Review will not be visible until the current Continuing Review has been approved.

Picture of CATS IRB page to select modification, continuing review or administrative review

 

When the Modification radio button is selected, the Modification Scope options are visible. Select the appropriate modification type: “Study team member information” or “other parts of the study.”

Picture of creating a modification in CATS IRB

 

Picture of Mod Info page in CATS IRB

Complete the modification information, which is dependent on the type of modification. For question #3, summarize the modification by providing a complete summary of all changes being made (include rationale for changes) and note when the changes impact other documents, such as the consent form.  

For example, “Due to construction, the interview site will change from 111 Boucke Building to 110 Chambers Building. The consent form detailing the interview site as well as they study protocol are updated to reflect this change in location.”

 

For assistance summarizing a modification, view the help text by clicking on the question mark next to question #3. The help text is shown below.

Help text for creating a modification

 

Submit a Modification

Select update (not ADD) to upload new versions of all documents impacted by the modification. Click “Save and Exit” on the final page once all changes have been made.

Note: Modifications can be edited prior to submitting by selecting the Edit Modification/CR button under Next Steps.

Click “Submit” to send the modification to the IRB for review.

Only the PI or the PI Proxy can Submit. If Submit is not selected, the modification will remain in the pre-submission state and will not be submitted. The PI or the PI Proxy will be required to enter their credentials to complete the submission.

Next Steps menu with Submit button for modification highlighted

 

Confirm a Submission

 

The modification submission is recorded in the History log and the workflow will also change from pre-submission to pre-review. The PI and the Primary Contact will be notified by email when the modification is approved.

Picture of the History of Modifications for a study

Pre-review flowchart