Get the free Continuing review report renewal request - Mercy Health Muskegon

Institutional Review Board 200 Jefferson Ave. SE Grand Rapids, MI 49503 P: 616.685.6198 F: 616.685.3044 CONTINUING REVIEW REPORT/ RENEWAL REQUEST Federal regulations require a protocol review within

How to fill out continuing review report renewal

How to fill out continuing review report renewal:

1. Begin by reviewing the instructions provided by the regulatory body or organization requiring the review report renewal. Familiarize yourself with the specific requirements and guidelines for filling out the form.
2. Gather all relevant information and documentation related to the study or project being reviewed. This may include previous reports, study protocols, informed consent documents, participant enrollment numbers, adverse event reports, and any other relevant data or materials.
3. Start by providing basic information about the study or project, such as the title, principal investigator, institutional affiliation, and dates of the original review.
4. Proceed to provide a detailed summary of the progress and status of the study or project since the last review. Include any milestones achieved, changes made to the protocol or informed consent, recruitment updates, and any challenges or issues encountered during the review period.
5. Clearly address any amendments or modifications made to the study protocol, informed consent process, or any other aspects of the research. Explain the reasons for these changes and provide supporting documentation if necessary.
6. Discuss participant safety and welfare measures. Report any adverse events or unanticipated problems that have occurred during the review period and describe the actions taken to address them. Provide documentation of communication with participants and any measures taken to mitigate risks.
7. Describe any changes made to the study staff, including the addition or removal of investigators or coordinators. Provide updated CVs or qualifications of new personnel and explain how their inclusion affects the conduct of the study.
8. Ensure that all required signatures and dates are provided, including those of the principal investigator, study team members, and any relevant institutional officials.
9. Submit the completed continuing review report renewal form along with any additional requested documentation to the appropriate regulatory body or organization within the specified timeframe.

Who needs continuing review report renewal?

1. Researchers and investigators conducting human subjects research or clinical trials that have been previously approved by an ethical review board or institutional review board (IRB) generally require a continuing review report renewal.
2. Institutions or organizations that oversee research activities, such as universities, hospitals, or pharmaceutical companies, may also require continuing review report renewal as part of their compliance with regulatory guidelines.
3. Regulatory bodies, such as the Food and Drug Administration (FDA) or the Office for Human Research Protections (OHRP), may require continuing review report renewal to ensure ongoing compliance and oversight of research involving human subjects.

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What is continuing review report renewal?

Continuing review report renewal is the process of updating and renewing the review of a research study by an Institutional Review Board (IRB) in order to ensure that the study continues to meet ethical and regulatory standards.

Who is required to file continuing review report renewal?

Researchers conducting a research study involving human subjects are required to file continuing review report renewal.

How to fill out continuing review report renewal?

Continuing review report renewal can be filled out by providing updated information on the study protocol, recruitment methods, consent forms, and any adverse events or changes that have occurred since the initial approval.

What is the purpose of continuing review report renewal?

The purpose of continuing review report renewal is to ensure that research studies involving human subjects are conducted in an ethical and compliant manner.

What information must be reported on continuing review report renewal?

Information such as updated study protocol, recruitment methods, consent forms, and any adverse events or changes that have occurred since the initial approval must be reported on continuing review report renewal.