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Question: 1 / 400

What is required after a study has been terminated?

Notify the sponsor only

Notify the IRB and provide a summary report

After a study has been terminated, it is essential to notify the Institutional Review Board (IRB) and provide a summary report. This step is crucial because the IRB is responsible for protecting the rights and welfare of the participants involved in the research. A summary report typically includes details about the reasons for termination, the status of the participants, any adverse events or outcomes, and how the data collected will be handled. This communication ensures that the IRB can properly assess the impact of the termination on participant safety and make informed decisions about ongoing oversight.

In contrast, notifying the sponsor alone would not fulfill the ethical and regulatory obligations to the IRB and the participants involved in the study. Submitting final reports solely to the subjects neglects the need for accountability and oversight from the IRB. Closing all accounts may be an administrative necessity, but it does not address the obligations related to the ethical conduct of research or the welfare of the participants. Therefore, notifying the IRB and providing a summary report is the most comprehensive and responsible action that must be taken after the termination of a study.

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Submit final reports to the subjects only

Close all accounts associated with the trial

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