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APPENDIX F: CONTINUING REVIEW LOCAL CONTEXT WORKSHEETPlease complete a copy of this worksheet for each relying on institution. This form should be completed by the Site Principal Investigator (PI)/Lead
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How to fill out appendix f continuing review

01
To fill out Appendix F Continuing Review, follow these steps:
02
Start by providing basic information about the study, such as the study title, principal investigator's name, and the IRB protocol number.
03
Describe any changes made to the study since the last review. Include details about modifications to the study design, recruitment methods, or study population.
04
Summarize the progress and outcomes of the study. Include information about participant enrollment, data collection, any adverse events or reportable incidents, and preliminary results if available.
05
Address any concerns or issues raised during the previous review. Explain how these issues were resolved and provide any relevant documentation.
06
Provide a plan for future activities and any proposed changes to the study. This may include modifications to study procedures, recruitment strategies, or data analysis methods.
07
Include a revised consent form if there have been updates or changes to the original version.
08
Submit the completed Appendix F Continuing Review to the appropriate IRB for review and approval.
09
Once the review is completed, carefully review any feedback or suggested changes from the IRB and make necessary revisions to the study protocol or consent form.
10
Finally, submit the revised materials and any additional documents requested by the IRB, ensuring compliance with all regulations and guidelines.
11
Remember to maintain accurate records of all correspondence and submissions to the IRB for future reference.

Who needs appendix f continuing review?

01
Appendix F Continuing Review is required for individuals or organizations conducting research that falls under institutional review board (IRB) oversight.
02
Researchers who have received IRB approval for their study are typically required to submit a Continuing Review at regular intervals to ensure the study continues to meet ethical and regulatory standards.
03
The specific criteria for who needs to submit Appendix F Continuing Review may vary depending on the policies and guidelines of the institution and the nature of the research being conducted.
04
It is important to consult with your institution's IRB or research compliance office to determine if you are required to complete Appendix F Continuing Review for your study.

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Appendix F continuing review is a process in research studies that involves the ongoing evaluation of the study to ensure compliance with regulatory requirements and to address any changes or new information.
Principal investigators and researchers conducting research studies that require ongoing review and monitoring are required to file appendix F continuing review.
To fill out Appendix F continuing review, researchers must provide updated information on study progress, any changes to study protocols, and any adverse events or new information that may impact the study.
The purpose of Appendix F continuing review is to ensure that research studies are conducted ethically and in compliance with regulations, to monitor study progress, and to address any changes or new information that may impact the study.
Information that must be reported on Appendix F continuing review includes study progress, changes to study protocols, adverse events, and any new information that may impact the study.
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