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Guidance for IRS, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval U.S. Department of Health and Human Services Food and Drug Administration Center
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What is irb continuing review after?
The IRB continuing review is conducted after initial approval to ensure that the research continues to meet ethical standards and regulatory requirements.
Who is required to file irb continuing review after?
Researchers conducting human subjects research are required to file IRB continuing review after.
How to fill out irb continuing review after?
To fill out IRB continuing review after, researchers must provide updated information about the study protocol, consent forms, and any new information or changes that have occurred since the initial approval.
What is the purpose of irb continuing review after?
The purpose of IRB continuing review after is to ensure that the research continues to protect the rights and welfare of human subjects throughout the duration of the study.
What information must be reported on irb continuing review after?
Researchers must report any changes to the study protocol, consent forms, recruitment materials, adverse events, and any new information that may impact the ethical conduct of the research.
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