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Application for the continuing review of an institutional research project by the University of Oklahoma Health Sciences Center's Institutional Review Board.

How to fill out application for continuing review

How to fill out Application for Continuing Review

1. Start by downloading the Application for Continuing Review form from the appropriate institutional website.
2. Fill in the basic information about the study, including the title, principal investigator, and funding sources.
3. Provide a summary of the research that has been conducted so far, including any findings and progress made.
4. List any changes to the study protocol or methodology since the last review.
5. Include information about any adverse events that have occurred during the study.
6. Update the recruitment status, including the number of participants enrolled and any anticipated recruitment challenges.
7. Attach any relevant documents or data that support the application, such as updated consent forms or progress reports.
8. Review the entire application for completeness and accuracy before submission.
9. Submit the completed form to the relevant review board or ethics committee by the deadline.

Who needs Application for Continuing Review?

1. Researchers or investigators conducting ongoing studies requiring ethical oversight.
2. Organizations or institutions that are accountable for ensuring participant safety and regulatory compliance.

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?

The Application for Continuing Review is a document submitted to an Institutional Review Board (IRB) to evaluate the ongoing compliance of a research study with ethical and regulatory standards.

Who is required to file Application for Continuing Review?

Researchers or investigators conducting studies that have received prior IRB approval are required to file an Application for Continuing Review before the approval expires.

How to fill out Application for Continuing Review?

To fill out the Application for Continuing Review, researchers should provide updated information on the study's progress, participant data, any changes in the research protocol, and details on any adverse events or new findings.

What is the purpose of Application for Continuing Review?

The purpose of the Application for Continuing Review is to ensure the ongoing protection of study participants and to assess whether the study continues to meet ethical standards and regulatory requirements.

What information must be reported on Application for Continuing Review?

Information that must be reported includes the current status of the study, participant recruitment numbers, any modifications to the protocol, findings from previous phases, incidents of adverse events, and any new information that may affect participant risk.