ExpertHard1 markMultiple Choice
Task 1: Plan and manage project compliancecompliance managementregulatory requirementsrisk containmentFDA regulations
PMP · Question 06 · Task 1: Plan and manage project compliance
A pharmaceutical project must comply with FDA regulations for clinical trial data management. During a routine audit preparation, the project manager discovers that a team member has been storing patient data in a non-compliant cloud storage system for the past month. What should the project manager do FIRST?
A pharmaceutical project must comply with FDA regulations for clinical trial data management. During a routine audit preparation, the project manager discovers that a team member has been storing patient data in a non-compliant cloud storage system for the past month. What should the project manager do FIRST?
Answer options:
A.
Document the compliance violation in the risk register for future reference
B.
Immediately halt the affected work and assess the full scope of the compliance breach
C.
Report the team member to HR for not following established procedures
D.
Schedule additional compliance training for the entire team
How to approach this question
In compliance scenarios, immediate containment and assessment of the breach takes priority over documentation, training, or disciplinary actions.
Full Answer
B.Immediately halt the affected work and assess the full scope of the compliance breach✓ Correct
B
Compliance violations in regulated industries can have severe consequences. Immediate containment prevents further violations while assessment determines the full scope of impact.
Common mistakes
Prioritizing documentation or training over immediate risk containment. In compliance scenarios, containment always comes first.
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