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This document provides an update on the revised Application for Continuing Review form by OPRS, highlighting new questions for review and submission requirements.

How to fill out application for continuing review

How to fill out Application for Continuing Review

1. Obtain the Application for Continuing Review form from the institution's review board or ethics committee.
2. Review the instructions provided with the form carefully.
3. Fill out the identification section with your study title, principal investigator's name, and protocol number.
4. Summarize any changes made to the study since the last review, including modifications to procedures or participant recruitment.
5. Provide updates on participant recruitment, including the number of participants enrolled and any adverse events that have occurred.
6. Include a detailed description of the current status of the study, highlighting any new findings or changes in study procedures.
7. Answer all questions related to compliance with ethical standards and safety monitoring.
8. Review the completed application for accuracy and completeness.
9. Submit the application by the specified deadline to the appropriate review board.

Who needs Application for Continuing Review?

1. Researchers and investigators conducting studies that require ongoing ethical oversight.
2. Any institution or organization that is managing a research project involving human subjects or animal research.
3. Principal investigators who are responsible for ensuring that their projects meet ethical standards throughout the study duration.

People Also Ask about

What is the continuing IRB review required for?

What is Continuing Review? If you want to continue working on a study beyond its expiration date, you must submit the study to the IRB for continuing review approval. The IRB re-reviews the study to determine if it is appropriate for the study to continue, as is or with modifications.

What is the purpose of the year end review?

A year end review is usually a formal conversation about a worker's achievements and areas for improvement. It is a time for managers to provide constructive feedback about the employee's performance. Likewise, workers may share details about their experience.

What is the purpose of the continuing review?

Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

What is an appropriate timeframe for an IRB to recommend a continuing review of a study?

To ensure that there is adequate time for the IRB to process the Continuing Review, the information should be submitted no sooner than 60 days but no later than 30 days before the study's expiration date.

What is the common rule for continuing review?

A. Under the Revised Common Rule, the regulations no longer require annual continuing review for minimal risk (expedited) research studies. The IRB may; 1) still require a continuing review, 2) require submission of a progress report at periodic intervals, or 3) not require additional reporting on the study's progress.

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 is the common rule for continuing review?

A. Under the Revised Common Rule, the regulations no longer require annual continuing review for minimal risk (expedited) research studies. The IRB may; 1) still require a continuing review, 2) require submission of a progress report at periodic intervals, or 3) not require additional reporting on the study's progress.

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.

For pdfFiller’s FAQs

What is Application for Continuing Review?

An Application for Continuing Review is a formal request submitted to an Institutional Review Board (IRB) to assess the ongoing conduct of an approved research study involving human subjects, ensuring compliance with ethical standards.

Who is required to file Application for Continuing Review?

Researchers or principal investigators of studies that have received prior IRB approval are required to file an Application for Continuing Review to continue their research activities beyond the initial approval period.

How to fill out Application for Continuing Review?

To fill out an Application for Continuing Review, researchers must provide updates on the study's progress, any changes to the protocol, participant recruitment, informed consent processes, and any adverse events, along with any other required documentation as specified by the IRB.

What is the purpose of Application for Continuing Review?

The purpose of the Application for Continuing Review is to ensure ongoing oversight of the research study by the IRB, assess participant safety, and verify that the study continues to meet ethical standards and regulations.

What information must be reported on Application for Continuing Review?

Information that must be reported on the Application for Continuing Review includes updates on participant enrollment, any changes to the research protocol, informed consent processes, unanticipated problems or adverse events, and the overall status of the research project.