Get the free Continuing Review and Termination Form - oakwood

This document is used to report the status of research projects to the Oakwood University Institutional Review Board (IRB), including project initiation, ongoing status, and project completion.

How to fill out continuing review and termination

How to fill out Continuing Review and Termination Form

1. Obtain the Continuing Review and Termination Form from the appropriate regulatory body or institution.
2. Read the instructions carefully to understand the requirements.
3. Fill in the study title and protocol number at the top of the form.
4. Provide details about the principal investigator and contact information.
5. Indicate the current status of the study (active, terminated, or suspended).
6. Summarize any changes that have occurred since the last review, including changes in protocol, recruitment, or adverse events.
7. Include updated consent forms and any material changes for IRB consideration.
8. Attach any relevant documents such as progress reports, data safety monitoring reports, or site visit findings.
9. Review the completed form for accuracy and completeness.
10. Submit the form by the designated deadline to the institutional review board (IRB) or ethics committee.
11. Await confirmation of receipt and any requests for further information or clarification.

Who needs Continuing Review and Termination Form?

1. Researchers conducting ongoing studies that require annual or periodic review.
2. Institutional review boards (IRBs) to maintain oversight of human subjects research.
3. Sponsors or funding agencies that require documentation of study compliance.

People Also Ask about

What is continual review?

Continuous Review is used throughout the development process: after any major event, incident, delivery, mission failure or success. Continuous Review encourages “blameless reporting” and removes any threatening posture or assigning blame for errors, omissions, and mistakes.

Do exempt studies require continuing review?

Studies that qualify for an exemption do not undergo continuing review. Additionally, modifications do not need to be submitted for exempt studies so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found were applicable to the research.

What is the continuing review of an approved non exempt protocol?

Continuing Review (CR) is the ongoing, scheduled IRB review of a previously approved non-exempt human subjects research study, at intervals appropriate to the degree of risk, but not less than once per year (364 Days), except as described in 45 CFR 46.109(f) for research that is subject to the 2018 Common Rule.

What are the three levels of review?

The IRB recognizes three types of research applications: 1) Exempt Review, 2) Expedited Review, and 3) Full Review.

What does continuing review mean?

Continuing Review is the process by which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during initial review.

What is a continuing review?

Continuing Review is the process by which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during initial review.

What is the Common Rule for continuing review?

Continuing Review: For new studies approved or determined exempt under the 2018 revised Common Rule, continuing review will not be required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.

For pdfFiller’s FAQs

What is Continuing Review and Termination Form?

The Continuing Review and Termination Form is a document used by research ethics committees to evaluate ongoing research studies. It collects information necessary to assess the progress of a study and determine whether it should continue or be terminated.

Who is required to file Continuing Review and Termination Form?

Researchers or study sponsors are required to file the Continuing Review and Termination Form. It is typically submitted by the principal investigator or the research team's lead member to the institutional review board (IRB).

How to fill out Continuing Review and Termination Form?

To fill out the Continuing Review and Termination Form, researchers should provide detailed information about the study's progress, changes made since the last review, any adverse events, and updated participant data. Specific instructions from the IRB should also be followed.

What is the purpose of Continuing Review and Termination Form?

The purpose of the Continuing Review and Termination Form is to ensure the ongoing ethical conduct of research and participant safety. It allows the IRB to monitor studies, evaluate any risks, and decide whether the research can continue or should be terminated.

What information must be reported on Continuing Review and Termination Form?

The form must report information such as the study's current status, any changes to the protocol, adverse events, data on participant recruitment and retention, and overall findings. It may also require updates on funding or compliance with previous IRB recommendations.