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Southern Methodist University Institutional Review Board (IRB) Continuing Review Report Form In accordance with the Code of Federal Regulations (CFR) Title 45 Part 46.109, the IRB shall conduct a

How to fill out continuing reviewirbdocx - smu

How to Fill out the Continuing Reviewirbdocx:

1. Access the document: Open the continuing reviewirbdocx on your computer or device.
2. Provide study information: Fill in all required fields with accurate information regarding your study, such as the title, study objectives, and principal investigator's contact details.
3. Update participant information: If any changes have occurred since the initial review, ensure that participant details are accurately updated to reflect any new participants or changes in demographics.
4. Evaluate study progress: Provide an overview of the study's progress since the initial review, including recruitment, participant enrollment, and any modifications made to the study protocol.
5. Update informed consent process: If changes have been made to the informed consent process, such as updates to the consent form or additional safeguards, ensure that these are clearly stated in the continuing reviewirbdocx.
6. Address any adverse events: If any adverse events or unanticipated problems have occurred during the study, provide a detailed account of these events and how they were handled.
7. Review and update study risks: Assess and update the risks associated with the study, ensuring that they are accurately described and any potential harm to participants is minimized.
8. Renewal and expiration dates: Check the renewal and expiration dates of the continuing reviewirbdocx to ensure that it remains valid and up to date. If a renewal is required, plan accordingly to submit the document within the specified timeframe.

Who needs Continuing Reviewirbdocx?

Researchers and investigators conducting studies involving human subjects are typically required to complete and submit the continuing reviewirbdocx. This document allows the Institutional Review Board (IRB) to assess the ongoing progress of a study, evaluate any changes or updates, verify the continued protection of participants, and ensure compliance with ethical guidelines and regulations. It is necessary for researchers to regularly review, update, and submit the continuing reviewirbdocx to maintain study approval and adhere to the guidelines set forth by the IRB and relevant regulatory bodies.

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What is continuing reviewirbdocx?

Continuing reviewirbdocx is a form used in research studies involving human participants to assess the ongoing ethical and safety considerations of the study.

Who is required to file continuing reviewirbdocx?

The Principal Investigator or research team responsible for the study is required to file the continuing reviewirbdocx.

How to fill out continuing reviewirbdocx?

Continuing reviewirbdocx should be carefully completed by providing updated information about the study protocol, participant safety, ethical considerations, and any changes since the initial approval.

What is the purpose of continuing reviewirbdocx?

The purpose of continuing reviewirbdocx is to ensure that research studies involving human participants are conducted ethically and in compliance with regulations to protect the rights and well-being of participants.

What information must be reported on continuing reviewirbdocx?

Continuing reviewirbdocx must include information such as study progress, any adverse events or protocol deviations, updated consent forms, and any changes to the study protocol.