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This document outlines the requirements for continuing review submissions to the Holy Cross Hospital Institutional Review Board, including necessary forms and information needed for the review process.

How to fill out continuing review submission form

How to fill out Continuing Review Submission Form

1. Begin by gathering all required study documents before starting the form.
2. Fill in the study title in the designated field.
3. Provide the Principal Investigator's name and contact information.
4. Enter the study protocol number and IRS number.
5. Review and summarize any changes to the study since the last review.
6. Update the recruitment status and participant count.
7. Include a brief update on any adverse events or unanticipated problems.
8. Attach any necessary supporting documents, such as revised consent forms.
9. Certify that the information provided is accurate and complete.
10. Submit the form by the deadline specified by the review board.

Who needs Continuing Review Submission Form?

1. All researchers conducting studies involving human subjects.
2. Institutional Review Board (IRB) members responsible for oversight.
3. Funding agencies requiring documentation of ongoing research.

People Also Ask about

What is a continuing review?

Continuing Review is a federally mandated re-evaluation of an approved study that is required to be conducted at least once per year.

What is the continuing review of an approved study?

The IRB re-reviews the study to determine if it is appropriate for the study to continue, as is or with modifications. Continuing review is required even if: No changes have been made since the last approval. The only study activity is subject follow-up.

What are the three levels of review?

There are three levels of IRB review for human subjects' research: exempt, expedited , and convened. Institutional policy requires IRB review of all human subjects' research that falls into an exempt or expedited review category.

What is an IRB progress report?

A progress report is an institutionally required study update that must be submitted to the JHM IRB at a designated interval. The purpose of the progress report is to ensure the study is being conducted in a compliant manner and there are no issues with the conduct of the research that would prevent continued approval.

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.

Who is responsible for maintaining continuous approval of a protocol?

Maintaining continuous IRB approval for a study is the responsibility of the Principal Investigator and the study team.

Which of the following is the purpose of 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

How often is the continuing review of an approved study required to be completed?

An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)).

How often does an IRB continuing review occur?

An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)).

For pdfFiller’s FAQs

What is Continuing Review Submission Form?

The Continuing Review Submission Form is a document used by researchers to provide updates and seek approval from an Institutional Review Board (IRB) for ongoing research studies involving human participants.

Who is required to file Continuing Review Submission Form?

Researchers conducting studies that have received initial IRB approval and are still in the active phase of research are required to file a Continuing Review Submission Form.

How to fill out Continuing Review Submission Form?

To fill out the Continuing Review Submission Form, researchers should provide detailed updates on the research progress, any changes to the study protocol, participant recruitment status, adverse events, and any new risks or ethical considerations since the last review.

What is the purpose of Continuing Review Submission Form?

The purpose of the Continuing Review Submission Form is to ensure that the IRB can evaluate the ongoing safety and ethical implications of a research study as it progresses and to confirm that it continues to meet regulatory and institutional standards.

What information must be reported on Continuing Review Submission Form?

The information that must be reported includes the number of participants enrolled, any amendments to the study protocol, adverse events or unanticipated problems, participant demographics, and a summary of findings to date.