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This document outlines the policies and procedures for the continuing review of research involving human participants at the University of Oklahoma, detailing requirements for IRB review, approval

How to fill out sop 404 continuing review

How to fill out SOP 404 Continuing Review

1. Gather necessary information regarding the study protocol and previous reviews.
2. Complete section A: study details, including study title, ID, and principal investigator.
3. Fill out section B: current status of the study, mentioning participant enrollment and any adverse events.
4. Complete section C: updates to the protocol or informed consent documents, if applicable.
5. Provide a summary of any new information that may affect the study or its participants.
6. Fill out section D: any changes in the investigator team or study sites.
7. Review all information for accuracy and completeness before submission.
8. Submit the SOP 404 Continuing Review form to the appropriate review board for approval.

Who needs SOP 404 Continuing Review?

1. All researchers and principal investigators conducting studies that require ongoing review and oversight.
2. Institutions or organizations that have ethical review boards to ensure compliance with safety and ethical standards.
3. Studies that are subject to regulatory requirements necessitating regular review and reporting.

People Also Ask about

What is a continuing review of an approved study?

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 for research that is subject 45 CFR 46.109(f) to the 2018 Common Rule.

Is the chop IRB continuing review?

The CHOP IRB includes an application for continuing review within eIRB. The frequency of continuing review for the research is determined by the IRB. FDA regulated research and federally funded research approved under the pre-2018 Common Rule require continuing review at least annually.

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 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.

How often do regulations require IRB 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. The clock starts on the date of approval, whether or not subjects have been enrolled.

Do regulations require IRBs to review ongoing?

IRB approval for a research project is valid for no more than one year. The federal regulations require IRBs to conduct continuing reviews of research at intervals appropriate to the degree of risk, but not less than once a year.

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

For pdfFiller’s FAQs

What is SOP 404 Continuing Review?

SOP 404 Continuing Review refers to the procedure for ongoing oversight of research protocols to ensure that they remain in compliance with regulatory and ethical standards throughout the duration of the study.

Who is required to file SOP 404 Continuing Review?

Researchers or investigators who are conducting studies that require ongoing review by an Institutional Review Board (IRB) or ethics committee are required to file SOP 404 Continuing Review.

How to fill out SOP 404 Continuing Review?

To fill out SOP 404 Continuing Review, researchers must complete the prescribed forms provided by the IRB, including details about the study's progress, any adverse events, and updates on participant recruitment. It is critical to provide thorough and accurate information.

What is the purpose of SOP 404 Continuing Review?

The purpose of SOP 404 Continuing Review is to ensure that ongoing research remains ethical and that participant safety is prioritized, while also evaluating the continued validity and relevance of the study.

What information must be reported on SOP 404 Continuing Review?

Information that must be reported includes updates on participant enrollment, any adverse events or complications, changes to the research protocol, and any new information that may affect the risk-benefit analysis of the study.