Sample interview questions: Can you discuss your experience with the preparation and submission of medical device clinical trial protocols for regulatory review?
Sample answer:
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Preparation of Medical Device Clinical Trial Protocols:
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Protocol Development:
- Collaborated with cross-functional teams (clinical, regulatory, quality assurance, and biostatistics) to develop comprehensive clinical trial protocols.
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Scientific Rationale:
- Conducted extensive literature reviews and analyzed preclinical data to establish the scientific rationale for the clinical investigation.
- Identified the primary and secondary objectives, endpoints, and study hypotheses.
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Study Design:
- Determined the appropriate study design (randomized controlled trial, observational study, etc.) based on the research question and regulatory requirements.
- Specified the inclusion and exclusion criteria to ensure patient safety and study integrity.
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Investigational Device Description:
- Collaborated with device engineers and regulatory experts to develop a detailed description of the investigational device, including its intended use, design, performance specifications, and safety features.
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Patient Population and Sample Size:
- Defined the target patient population and estimated the required sample size to achieve meaningful results.
- Considered factors such as disease prevalence, study duration, and anticipated effect size.
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Study Procedures:
- Developed detailed procedures for patient recruitment, screening, enrollment, follow-up, and data collection.
- Included instructions for device implantation, use, and maintenance, as well as adverse event reporting.
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Data Management and Statistical Analysis:
- Specified the data collection methods, including electronic data capture systems and case report forms.
- Collaborated with statisticians to determine the appropriate statistical methods for analyzing the study data.
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Safety Monitoring:
- Developed a comprehensive safety monitoring plan to identify and mitigate potential risks to study participants.
- Included procedures for reporting and managing adverse events, serious adverse events, and unanticipated adverse device effects.
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Regulatory Compliance:
- Ensured that the clinical trial protocol complies with all applicable regulatory requirements, including local, national, and international regulations.
- Liaised with regulatory authorities to address any queries or concerns.
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Submission of Medical Device Clinical Trial Protocols for Regulatory R… Read full answer
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