Closing a Study Study closure in ETHOS is determined by achieving study milestones. A study may be closed when a) the research is permanently closed to enrollment, b) all participants have completed all research-related interventions/interactions, c) collection of private identifiable information is complete, and d) analysis of private identifiable information is complete. Continued IRB approval is not required when the remaining study activities are limited to analysis of deidentified data and/or manuscript preparation. To submit a study closure request in ETHOS:
IMPORTANT TIPS
1. Follow the steps for submitting a Continuing Review.
2. Check the first four research milestones if they apply. When these items are checked, the study may be closed and will no longer require IRB oversight.
3. Submit the form for IRB Review. Only the PI can submit.
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Refer to the Continuing Review quick guide for guidance on how to create a continuing review submission. Note: If study data was once identifiable but has since been completely deidentified (no identifiers remain or no link between identifiers and data exist), it may still be analyzed after study closure. Note: Any open modifications and continuing reviews will be discarded by the IRB when a study is closed. However, any RNI submissions will not be closed automatically when a study is closed and must still complete the IRB review process.
be closed automatically when. a study is closed and must. still complete the IRB review. process. Page 1 of 1. How to Submit a Study Closure Quick Guide.pdf.
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Page 1 of 1. Create New Study. Version 1.0 2/22/2017. Page 1 of 1. Create and Submit a New Study. Before creating a new study in ETHOS, refer to the New ...
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