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    PracticePMI PMP®PMI PMP Practice Exam 2Question 08
    Hard1 markMultiple Choice
    Task 1: Plan and manage project compliancecompliance-managementregulatory-requirementsdata-securityrisk-containment

    PMP · Question 08 · Task 1: Plan and manage project compliance

    A pharmaceutical company project must comply with FDA regulations for clinical trial data management. During a routine audit preparation, the project manager discovers that a team member unknowingly used a non-compliant cloud storage method for storing patient data for the past three weeks. The data includes personally identifiable information and clinical trial results. What should the project manager do FIRST?

    Answer options:

    A.

    Document the issue in the risk register and schedule a compliance review meeting

    B.

    Immediately halt the affected work and assess the full scope of the compliance impact

    C.

    Report the team member to HR for not following established procedures

    D.

    Update the project management plan to include additional compliance training

    How to approach this question

    In compliance violations, especially with regulated industries and sensitive data, immediate containment and assessment must come before documentation, training, or disciplinary actions.

    Full Answer

    B.Immediately halt the affected work and assess the full scope of the compliance impact✓ Correct
    FDA compliance violations involving patient data require immediate action to contain the violation and assess its full scope. This takes priority over documentation, training, or disciplinary measures.

    Common mistakes

    Prioritizing documentation, training, or disciplinary actions over immediate containment of active compliance violations.
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