Get the free Continuing Review Form

This form is used for continuing review of clinical trials by the Institutional Review Board (IRB) at Rex Healthcare. It collects information on the study status, patient enrollment, adverse events,

How to fill out continuing review form

How to fill out Continuing Review Form

1. Gather all necessary study documents, including protocol, informed consent forms, and any prior review feedback.
2. Open the Continuing Review Form provided by your Institutional Review Board (IRB).
3. Fill in the study title and principal investigator's contact information.
4. Provide a summary of the study's progress, including participant enrollment numbers and any adverse events.
5. Discuss any amendments made to the study since the last review.
6. Outline plans for future research and notify about any changes in financial support.
7. Complete any additional sections as required by the IRB specific to your study.
8. Review your entries for accuracy and completeness.
9. Submit the form according to the IRB's submission guidelines and deadline.

Who needs Continuing Review Form?

1. Researchers conducting studies involving human subjects.
2. Institutional Review Boards (IRBs) for monitoring ongoing research.
3. Organizations funding the research to ensure compliance with ethical standards.

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 by researchers to report on the progress of an ongoing study to an Institutional Review Board (IRB), ensuring that the study remains in compliance with ethical standards and regulations.

Who is required to file Continuing Review Form?

Researchers or principal investigators conducting studies that require IRB approval are required to file the Continuing Review Form at specified intervals, typically annually.

How to fill out Continuing Review Form?

To fill out the Continuing Review Form, researchers must provide detailed information on the study's progress, any adverse events, changes to the protocol, and ongoing participant recruitment, ensuring all sections of the form are completed accurately.

What is the purpose of Continuing Review Form?

The purpose of the Continuing Review Form is to assess the ongoing ethical soundness of a research study, to ensure participant safety, and to determine if the research plan is still valid and compliant with regulatory requirements.

What information must be reported on Continuing Review Form?

Information that must be reported includes the current status of the study, number of participants enrolled, any adverse events that occurred, changes to the study protocol, and an update on the risk-benefit analysis for participants.