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This document serves as a worksheet for the continuing review of research protocols submitted to the Human Investigation Committee (HIC), ensuring compliance with regulatory requirements regarding
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How to fill out 8b continuing review worksheet
How to fill out 8b CONTINUING REVIEW WORKSHEET
01
Start with your project title at the top of the worksheet.
02
Review your previously submitted protocols and ensure all sections are up-to-date.
03
Fill in the date of the continuing review in the specified section.
04
Outline any changes to the study design or procedures since the last review.
05
Provide updates on the recruitment of participants and any challenges faced.
06
Summarize any adverse events or unanticipated problems encountered during the study.
07
Indicate any modifications to the informed consent documents.
08
Sign and date the worksheet at the end, confirming all provided information is accurate.
Who needs 8b CONTINUING REVIEW WORKSHEET?
01
Researchers conducting studies that require ongoing IRB review.
02
Any institution or organization involved in human subjects research.
03
Principal investigators who need to report on the status of their research projects.
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What is 8b CONTINUING REVIEW WORKSHEET?
The 8b CONTINUING REVIEW WORKSHEET is a document used by institutional review boards (IRBs) to evaluate ongoing research projects. It helps ensure that the research complies with ethical standards and regulatory requirements throughout its duration.
Who is required to file 8b CONTINUING REVIEW WORKSHEET?
Researchers who are conducting ongoing human subjects research and wish to continue their projects beyond the initial approval period are required to file the 8b CONTINUING REVIEW WORKSHEET.
How to fill out 8b CONTINUING REVIEW WORKSHEET?
To fill out the 8b CONTINUING REVIEW WORKSHEET, researchers need to provide comprehensive information about the research project, including updates on the study's progress, any adverse events, changes to the protocol, and informed consent processes. It may also require details on recruitment, data analysis, and compliance with ethical standards.
What is the purpose of 8b CONTINUING REVIEW WORKSHEET?
The purpose of the 8b CONTINUING REVIEW WORKSHEET is to facilitate the assessment of ongoing research by IRBs, ensuring that the studies remain ethically sound and that the rights and welfare of participants continue to be protected.
What information must be reported on 8b CONTINUING REVIEW WORKSHEET?
The information that must be reported on the 8b CONTINUING REVIEW WORKSHEET includes the current status of the study, any updates since the last review, adverse events experienced, changes to the research protocol, informed consent processes, participant recruitment details, and any emerging ethical considerations.
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