Get the free Continuing Review Form

This form is used by the Institutional Review Board at Ball State University to review the status of ongoing research and ensure compliance with ethical standards. It requires completion of various

How to fill out continuing review form

How to fill out Continuing Review Form

1. Begin by gathering all necessary documents and information related to the original study.
2. Access the Continuing Review Form through the designated online system or consultation with the IRB office.
3. Fill in the study title and protocol number accurately as they appear in the original submission.
4. Provide a summary of progress on the study, including participant recruitment numbers and any deviations from the protocol.
5. Include any updates on adverse events and changes in the risk assessment.
6. Review and update the consent document if there have been any modifications.
7. Answer all required questions regarding the continuation of the study.
8. Ensure that all sections are complete and accurate before submission.
9. Submit the form to the appropriate Institutional Review Board for review and approval.

Who needs Continuing Review Form?

1. Researchers conducting a study that requires ongoing oversight and ethical review.
2. Institutional Review Boards (IRBs) that need to evaluate the continued ethical implications of a study.
3. Compliance officers or research administrators to maintain regulatory compliance.

People Also Ask about

When must IRB continuing review of a greater than minimal risk approve protocol that is currently enrolling subjects?

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: Occur at least annually. Include copies of all signed consent forms.

What is the continuing IRB review required for?

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 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.

How often do regulations require irbs to review ongoing research studies?

When an IRB approves a study, continuing review should be performed at least annually. All of the records listed in 21 CFR 56.115(a)(1) - (4) are required to be maintained.

What is an appropriate timeframe for an IRB to recommend a continuing review of a study: a 6 months b 18 months c 24 months?

(f) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

What is IRB continuing review and when should it occur?

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 requires an IRB review?

When is approval required? MDH researchers engaged in human subjects research must get IRB approval before gathering or analyzing data for the study. Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

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.

For pdfFiller’s FAQs

What is Continuing Review Form?

The Continuing Review Form is a document used in research to evaluate ongoing studies and ensure they comply with ethical standards and regulatory requirements.

Who is required to file Continuing Review Form?

Researchers or institutions conducting studies that require Institutional Review Board (IRB) oversight are required to file a Continuing Review Form to provide updates on the study's progress.

How to fill out Continuing Review Form?

To fill out a Continuing Review Form, researchers should provide detailed information about the study's progress, participant enrollment, any adverse events, and any changes to the study protocol or informed consent process.

What is the purpose of Continuing Review Form?

The purpose of the Continuing Review Form is to ensure the safety and rights of participants are being protected throughout the study, and to assess the study's continued ethical compliance and scientific validity.

What information must be reported on Continuing Review Form?

Information that must be reported on the Continuing Review Form includes the number of participants enrolled, any adverse events or side effects experienced, changes to the study protocol, updates on participant consent, and data on the study's progress.