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This document outlines the changes made to the Continuing Review Application Form, including the addition of a new verification question for study team members regarding sponsor amendments.

How to fill out continuing review form changes

How to fill out Continuing Review Form Changes

1. Gather all relevant study documentation including protocol, consent forms, and data collection tools.
2. Review any changes that have occurred since the last continuing review, including modifications to the study design or participant recruitment.
3. Access the Continuing Review Form provided by your Institutional Review Board (IRB).
4. Fill out the general study information section, providing details on the study title, principal investigator, and study site.
5. If applicable, list any changes made to the study since the last review, explaining the rationale for these changes.
6. Indicate any adverse events or unanticipated problems that have occurred during the study period.
7. Report the current enrollment status and any changes to the participant demographics.
8. Include any recent literature that may impact the study or its ongoing safety and efficacy.
9. Review and verify all information provided for accuracy and completeness.
10. Submit the completed form to the IRB along with any required supporting documents.

Who needs Continuing Review Form Changes?

1. Researchers conducting ongoing studies involving human participants.
2. Principal investigators responsible for ensuring compliance with ethical guidelines.
3. Institutional Review Boards (IRBs) reviewing and approving changes to research protocols.

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 requires an IRB review?

Faculty, staff, and students who wish to act as participants in their own research are considered human subjects. All self-experimentation human research activities require IRB review and approval prior to commencing the study.

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

How often does the IRB review ongoing research studies?

Ongoing research studies must be reviewed by the IRB at least annually, or more often if the IRB finds that the degree of risk to subjects warrants more frequent review.

What is a continuing review?

Definition. Continuing review of research refers to an official review which is conducted at a designated interval after a project has received initial review and approval by the Institutional Review Board (IRB) or Exempt Review Committee (ERC).

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.

Should an IRB IEC conduct continuing review of each ongoing trial?

The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.

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)).

For pdfFiller’s FAQs

What is Continuing Review Form Changes?

Continuing Review Form Changes refer to the process of updating necessary information and seeking approval for modifications related to ongoing research projects submitted to an Institutional Review Board (IRB) for continued ethical oversight.

Who is required to file Continuing Review Form Changes?

Researchers or study investigators who are conducting studies that have previously been approved by an IRB must file Continuing Review Form Changes as part of the ongoing compliance and oversight process.

How to fill out Continuing Review Form Changes?

To fill out Continuing Review Form Changes, researchers should complete the designated form provided by their IRB, ensuring to include updated study information, any changes to the research methodology, participant information, and any adverse events or issues that have arisen during the study.

What is the purpose of Continuing Review Form Changes?

The purpose of Continuing Review Form Changes is to maintain ongoing ethical oversight of research studies, ensure participant safety, assess any new risks, and evaluate the overall progress of the research.

What information must be reported on Continuing Review Form Changes?

Information that must be reported includes updates on study progress, changes in research procedures, any new adverse events or issues, participant accrual numbers, and any amendments to the consent process.