Get the free Continuing Review Form - brynmawr

This form is used by the Institutional Review Board at Bryn Mawr College to conduct a continuing review of an active research project, ensuring compliance with ethical standards and IRB regulations.

How to fill out continuing review form

How to fill out Continuing Review Form

1. Obtain the Continuing Review Form from the Institutional Review Board (IRB) or your research administrator.
2. Review the instructions provided with the form carefully.
3. Fill in the basic information about your study, including title, principal investigator, and study ID.
4. Provide a summary of the research conducted to date, noting any changes or updates since the initial approval.
5. Report any adverse events or unanticipated problems that have occurred during the study.
6. Attach any necessary documents, such as updated consent forms or protocol amendments.
7. Review the completed form for accuracy and completeness.
8. Submit the form to the IRB within the required timeframe.

Who needs Continuing Review Form?

1. All researchers conducting studies involving human subjects that require ongoing assessment are required to fill out a Continuing Review Form.
2. Principal investigators and co-investigators managing research projects.
3. Institutions and agencies that are overseeing research compliance and ethics.

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 studies to evaluate the ongoing safety and efficacy of a study after its initial approval. It is submitted to an Institutional Review Board (IRB) to review the progress of the study and ensure compliance with ethical standards.

Who is required to file Continuing Review Form?

Researchers and principal investigators conducting studies that have been approved by an IRB are required to file a Continuing Review Form at designated intervals, typically annually, to maintain the study's approval status.

How to fill out Continuing Review Form?

To fill out the Continuing Review Form, researchers should provide updates on the study's progress, including participant enrollment numbers, any adverse events, changes to the study protocol, and updated informed consent documents, along with any new relevant literature.

What is the purpose of Continuing Review Form?

The purpose of the Continuing Review Form is to ensure that the study continues to meet ethical standards and regulatory requirements, that participant safety is prioritized, and that the benefit-risk ratio remains favorable as the research progresses.

What information must be reported on Continuing Review Form?

The information that must be reported on the Continuing Review Form typically includes the current status of the study, any adverse events or safety concerns, the number of participants enrolled, updates on consent procedures, findings from interim analyses, and any proposed changes to the study protocol.