ExpertPMP · Question 67 · Task 1: Plan and manage project compliance
A pharmaceutical company project must comply with FDA regulations throughout development. The project manager discovers that a team member unknowingly used a non-compliant data storage method for clinical trial information, potentially affecting data integrity. What should the project manager do FIRST?
A pharmaceutical company project must comply with FDA regulations throughout development. The project manager discovers that a team member unknowingly used a non-compliant data storage method for clinical trial information, potentially affecting data integrity. What should the project manager do FIRST?
Answer options:
Document the compliance violation in the risk register and lessons learned
Immediately halt the affected work and assess the compliance impact with regulatory and quality experts
Report the team member to management for not following established compliance procedures
Update the project management plan to include additional compliance training and oversight
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