Sample interview questions: Can you explain your approach to monitoring and reviewing ongoing research activities for compliance purposes?
Sample answer:
Approach to Monitoring and Reviewing Ongoing Research Activities
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Risk Assessment:
- Conduct a comprehensive risk assessment to identify areas of potential non-compliance.
- Prioritize review activities based on risk levels, regulatory requirements, and funding agency mandates.
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Review Schedule:
- Establish a schedule for ongoing reviews tailored to the specific risks and complexity of the research.
- Schedule reviews at critical milestones, such as study initiation, participant enrollment, data collection, and manuscript submission.
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Review Process:
- Develop clear review procedures and checklists to ensure consistency and thoroughness.
- Conduct reviews through document audits, site visits, and interactions with researchers, staff, and participants.
- Focus on key aspects of compliance, including:
- Ethical conduct of research
- Informed consent and participant safety
- Data integrity and management
- Regulatory compliance
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Reporting and Tracking:
- Document review findings and any corrective or preventive actions taken.
- Maintain a centralized database to track compliance s… Read full answer
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