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How to Close a Study in eIRB
Texas Health Institutional Review Board
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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 [email protected]
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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.
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Give your study closeout a title. It is helpful to include the year as part of the title.
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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.
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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.
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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.
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When answering this question your selections should be consistent with what was approved at the last review.
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The sum total of all the numbers you enter should be your total accrual.
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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.
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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.
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When answering question CO-B summarize all adverse events (internal & external), unanticipated problems, and protocol deviations that have occurred in the past year.
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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.
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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.
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You do not have to submit a conflict of interest form when closing the study.
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This is the last page of the application.
Click “Finish” to finalize and exit the application.
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Only the PI can submit the study closeout.
Click here to send an email notification to the PI to submit the study closeout.
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Once you submit your closeout the state should change to awaiting IRB analyst assignment.