What should the investigator or sponsor communicate to the IRB/IEC regarding significant changes?

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Multiple Choice

What should the investigator or sponsor communicate to the IRB/IEC regarding significant changes?

Significant changes to a study must be reviewed in light of participant safety and rights, so the IRB/IEC must be informed promptly. Any modification that could affect the risk-benefit balance or how the trial is conducted—such as changes to procedures, eligibility criteria, informed consent, monitoring, or the way safety is assessed—should be communicated quickly. This enables the IRB/IEC to reassess risk and, when appropriate, review and approve the amendment before the changes are implemented. If there’s a need to take an urgent safety measure to protect participants, the change can be made to eliminate the hazard, but the IRB/IEC should be notified promptly afterward.

Significant changes to a study must be reviewed in light of participant safety and rights, so the IRB/IEC must be informed promptly. Any modification that could affect the risk-benefit balance or how the trial is conducted—such as changes to procedures, eligibility criteria, informed consent, monitoring, or the way safety is assessed—should be communicated quickly. This enables the IRB/IEC to reassess risk and, when appropriate, review and approve the amendment before the changes are implemented. If there’s a need to take an urgent safety measure to protect participants, the change can be made to eliminate the hazard, but the IRB/IEC should be notified promptly afterward.

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