Who may submit to the IRB/IEC regarding a clinical trial?

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Multiple Choice

Who may submit to the IRB/IEC regarding a clinical trial?

Submitting to the IRB/IEC is done by the party responsible for the trial at the site, which is typically the investigator on behalf of the institution or the sponsor, depending on local regulations. This submission includes the protocol, informed consent forms, investigator’s brochure, and related documents, and it must happen before the trial starts and whenever amendments or renewals are needed. The key idea is that the entity responsible for the trial’s conduct and regulatory compliance at that site makes the submission, not regulators or monitors. Regulators issue their own approvals or clearances, but they do not submit the study for IRB/IEC review. A monitor oversees activities but does not handle IRB submissions.

Submitting to the IRB/IEC is done by the party responsible for the trial at the site, which is typically the investigator on behalf of the institution or the sponsor, depending on local regulations. This submission includes the protocol, informed consent forms, investigator’s brochure, and related documents, and it must happen before the trial starts and whenever amendments or renewals are needed. The key idea is that the entity responsible for the trial’s conduct and regulatory compliance at that site makes the submission, not regulators or monitors. Regulators issue their own approvals or clearances, but they do not submit the study for IRB/IEC review. A monitor oversees activities but does not handle IRB submissions.

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