ExpertPMP · 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?
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:
Document the issue in the risk register and schedule a compliance review meeting
Immediately halt the affected work and assess the full scope of the compliance impact
Report the team member to HR for not following established procedures
Update the project management plan to include additional compliance training
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