Periodic review of a clinical trial should be conducted by which entity in accordance with applicable regulatory requirements?

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Multiple Choice

Periodic review of a clinical trial should be conducted by which entity in accordance with applicable regulatory requirements?

Periodic review of a clinical trial is the continuing ethical review of the study by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). This body reassesses the study at intervals appropriate to the level of risk to participants (and typically at least once a year) to ensure that the risks remain reasonable in relation to anticipated benefits, that informed consent is being properly obtained and updated as needed, and that participant rights, privacy, and welfare continue to be protected. The sponsor oversees trial operations and data integrity, but the regulatory-required ongoing ethical review is conducted by the IRB/IEC. The DSMB monitors safety data for certain trials and may make recommendations about continuing or stopping the trial, but it is not the entity responsible for the routine periodic ethical review. The FDA may review study data or inspect sites, but it does not perform the ongoing IRB/IEC-type continuing review as part of regulatory requirements.

Periodic review of a clinical trial is the continuing ethical review of the study by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). This body reassesses the study at intervals appropriate to the level of risk to participants (and typically at least once a year) to ensure that the risks remain reasonable in relation to anticipated benefits, that informed consent is being properly obtained and updated as needed, and that participant rights, privacy, and welfare continue to be protected. The sponsor oversees trial operations and data integrity, but the regulatory-required ongoing ethical review is conducted by the IRB/IEC. The DSMB monitors safety data for certain trials and may make recommendations about continuing or stopping the trial, but it is not the entity responsible for the routine periodic ethical review. The FDA may review study data or inspect sites, but it does not perform the ongoing IRB/IEC-type continuing review as part of regulatory requirements.

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