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What Is a Deviation in Clinical Research Trials?

A clinical research trial or protocol is the plan used to determine how a drug or device works in people. A deviation is any change in the plan from the original protocol approved by the Institutional Review Board (IRB).

  1. Informed Consent

    • Patients must understand the protocol.

      Patients must agree to participate in research and sign a written informed consent. Failure to get informed consent before starting research is a deviation. Informed consent must be obtained by a licensed physician.

    Enrolling Patients

    • Patients must meet certain criteria such as type of disease, age, and gender. Allowing a patient to participate who does not meet the criteria of a trial is a deviation.

    Steps in the Protocol

    • All drugs, agents, devices and tests used must be outlined in the protocol. If a patient does not complete all steps of the outlined research plan in a timely manner compliant with the study, a deviation occurs.

    Adverse Events

    • An adverse event occurs when a bad outcome from the protocol occurs. Drug errors such as wrong drug or dosage, drug reactions, device failures, and failure to report are considered major deviations that must be reported.

    Minor Deviations

    • Protocols must be followed step by step.

      Minor deviations do not impact patient safety or the accuracy of the trial. Examples of minor deviations that must be reported include missing original documents but copies are available, inappropriate informed consent documents, or failure to follow the protocol exactly.

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