Get the free Continuing Review/Termination Form - brynmawr

This form is used by the Institutional Review Board (IRB) at Bryn Mawr College to conduct a continuing review or termination of a research project, documenting project status and changes related to

How to fill out continuing reviewtermination form

How to fill out Continuing Review/Termination Form

1. Begin by obtaining the Continuing Review/Termination Form from the designated institutional review board (IRB) or ethics committee.
2. Fill in the study title and the principal investigator's name at the top of the form.
3. Provide the study ID number assigned by the IRB.
4. Indicate the current status of the study, specifying whether it is active, suspended, or terminated.
5. Fill in the dates for the initial approval, the last continuing review, and the anticipated completion date of the study.
6. Summarize any changes in the research protocol or study procedures since the last review.
7. Include details of any adverse events or unanticipated problems that have occurred during the study period.
8. Provide an update on participant enrollment, including the number of participants enrolled and demographic information.
9. Outline the plan for ongoing participant safety and monitoring.
10. Sign and date the form, and submit it by the specified deadline to the IRB for review.

Who needs Continuing Review/Termination Form?

1. Researchers conducting human subjects research that requires ongoing oversight.
2. Principal investigators of studies that are nearing the end of their IRB approval period.
3. Any research team members involved in studies that have experienced significant changes in protocol or adverse events.
4. Compliance officers and institutional authorities needing to ensure regulatory adherence.

People Also Ask about

How many years is IRB approval good for?

How long is my approval good for? Most IRB approvals expire one year from the date of approval (exceptions may occur). However, some research may be considered EXEMPT from continuing IRB review and will not be required to submit a scheduled continuation review (renewal) application on an annual basis.

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

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 is the timeline for the IRB?

Detention Review Hearings SectionTime LImits 16(1) & 17(1) & 26(b) & 32(2) & 45(4) & 46(4) Five days before the hearing 31(2) Seven days after mailed 39(3) & 40(3) Five days and three days, respectively. 47(4) Ten days6 more rows • Aug 2, 2024

What is an appropriate timeframe for an IRB to recommend a continuing review of a study?

To ensure that there is adequate time for the IRB to process the Continuing Review, the information should be submitted no sooner than 60 days but no later than 30 days before the study's expiration date.

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.

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. Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs may specify a shorter review period.

For pdfFiller’s FAQs

What is Continuing Review/Termination Form?

The Continuing Review/Termination Form is a document used by researchers to report on the status of their ongoing research projects to an Institutional Review Board (IRB). It helps ensure that the study continues to meet ethical standards and regulatory requirements.

Who is required to file Continuing Review/Termination Form?

Researchers and institutions conducting human subjects research that is subject to IRB oversight are required to file the Continuing Review/Termination Form as part of the ongoing review process.

How to fill out Continuing Review/Termination Form?

To fill out the Continuing Review/Termination Form, researchers should provide detailed information about the ongoing study, including updates on the study's progress, participant enrollment, any adverse events, and any modifications to the research protocol.

What is the purpose of Continuing Review/Termination Form?

The purpose of the Continuing Review/Termination Form is to ensure that the IRB can monitor the ongoing research for compliance with ethical standards and protect the rights and welfare of participants.

What information must be reported on Continuing Review/Termination Form?

The form typically requires information such as the study title, principal investigator, number of participants recruited, any adverse events, modifications to the study design, and the anticipated timeline for the study's completion.