how to close a study in eirb texas health institutional ... · do not close your study unless: ......

How to Close a Study in eIRB

Texas Health Institutional Review Board

All studies open with the IRB must be closed when the research is completed.

Do not close your study unless:

• All research activities are complete

• Follow up is complete

• Data has been analyzed

For questions please contact the IRB office at 682-236-6746 or irb@TexasHealth.org

Login at https://eirb.texashealth.org/

Go to the study that needs to be closed.

Click on “New Continuing Review.”

This will open up the continuing review application. A study closeout is submitted with the same application as a continuing review.

Give your study closeout a title. It is helpful to include the year as part of the title.

This is the first page of the closeout application.

Answer all red asterisk questions, and all other applicable questions.

A continuing review is required even when a study is closing.

Hypothesis, objectives, research design, and procedures should have not changed since the beginning of the study unless you have an amendment approval to do so.

When answering question CO-D be as detailed as you can.

Even though questions CO-F and CO-G are not required please answer them. If the questions don’t apply to you answer not applicable.

When answering this question your selections should be consistent with what was approved at the last review.

The sum total of all the numbers you enter should be your total accrual.

Check your numbers carefully before submitting. Question CO-A is asking about accrual for the entire length of your study. Question CO-B is asking about accrual during the past year.

There is no question that addresses lost to follow up. If you have any lost to follow up include them in questions CO-E, CO-F, and CO-G.

If you are closing your study the answer to question CO-I should be zero.

When answering question CO-B summarize all adverse events (internal & external), unanticipated problems, and protocol deviations that have occurred in the past year.

If you have had DSMB, monitoring, or audit reports within the past year you will need to upload them into question CO-G. This question will not pre-populate even if you have already submitted them to the IRB.

If you answer no to question CO-A the rest of these questions are not applicable. If you answer yes, you must answer every question on this page.

You do not have to submit a conflict of interest form when closing the study.

This is the last page of the application.

Click “Finish” to finalize and exit the application.

Only the PI can submit the study closeout.

Click here to send an email notification to the PI to submit the study closeout.

Once you submit your closeout the state should change to awaiting IRB analyst assignment.