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This document is used to report the closure of a research study reviewed by the Indiana University East Institutional Review Board (IRB), including information about study status, subject recruitment,

How to fill out indiana university east institutional

How to fill out INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT

1. Prepare all necessary documentation related to your research study.
2. Access the Indiana University East IRB Closeout Report form from the IRB website.
3. Fill in the basic information, including your name, department, and study title.
4. Provide the date the study was completed and any final data collection dates.
5. Summarize the research findings in a brief description.
6. Indicate whether the study was completed as planned or if there were any deviations.
7. Attach any final reports, publications, or manuscripts resulting from the study.
8. Review all information for completeness and accuracy.
9. Submit the completed Closeout Report to the IRB through the designated submission process.

Who needs INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT?

1. Researchers who have completed a study that was approved by the Indiana University East IRB.
2. Principal investigators or co-investigators of a research project.
3. Anyone who is required to officially close out their research project with the IRB.

People Also Ask about

How long do you have to keep IRB correspondence?

Records retained by the IRB. Records will be retained for three years post-study termination and may include, but are not limited to; approved protocols and consent forms; samples and/or approved test instruments; copies of grant proposals; review summaries; and related memoranda and correspondence.

When may an IRB suspend or terminate an ongoing clinical study answer?

IRB-Initiated Termination or Suspension of a Research Protocol. An IRB may suspend or terminate some or all research activities on a protocol if events are identified that represent serious or continuing noncompliance or unanticipated problems involving risk to subjects or others.

When to close an IRB protocol?

For studies previously reviewed and approved by the IRB or determined exempt, the study must be closed once human subject research activities conclude and prior to the study expiration date.

What is the Institutional Review Board IRB?

The IRB may conduct either an expedited or full board review for IRB-regulated research proposed in the Interaction/Intervention or Secondary Use application types to ensure: Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits. The subject selection is equitable.

What should you do if you deviate from the IRB approved protocol?

For non-exempt research, investigators must report protocol deviations to the IRB by completing and electronically submitting the appropriate Reportable Event Form available in IRBNet. The information in the report should allow the IRB to evaluate the nature and potential consequences of the deviation.

When an IRB is reviewing?

The institutional official (IO) may override the IRB's decision to approve research; however, they may not approve the research if it has not been approved by the IRB, nor can they overrule other decisions made by the IRB (See SOP 004: IRB Authority, Membership, and Responsibilities).

When to close an IRB?

Closing an IRB protocol Study closure should occur when: the study was not and will not be initiated; the study was discontinued prior to its completion; or the study has been completed.

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What is INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT?

The INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT is a document that researchers submit to officially conclude their research study, indicating that all research activities have been completed and that data collection is finalized.

Who is required to file INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT?

All principal investigators and co-investigators involved in research studies that were initially approved by the Indiana University East IRB are required to file a CLOSEOUT REPORT upon completion of their research.

How to fill out INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT?

To fill out the CLOSEOUT REPORT, researchers should provide information about the study's completion, including the final number of participants, a summary of findings, any adverse events, and confirmation that data has been appropriately secured or destroyed, among other required details.

What is the purpose of INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT?

The purpose of the CLOSEOUT REPORT is to formally document the end of a research project, ensure compliance with ethical standards, and provide the IRB with information necessary to assess the completion and ethical conduct of the study.

What information must be reported on INDIANA UNIVERSITY EAST INSTITUTIONAL REVIEW BOARD (IRB) CLOSEOUT REPORT?

The report must include information such as the study title, the principal investigator's name, the date of study completion, the total number of participants, a summary of any findings, details of any adverse events, and how data has been treated post-study.