Sample interview questions: How do you ensure compliance with study drug storage and handling procedures?
Sample answer:
- Verify storage conditions: Ensure that the study drug is stored according to the protocol-specified conditions (e.g., temperature, humidity, light exposure) by regularly monitoring storage areas and conducting temperature mapping studies.
- Train site staff: Provide comprehensive training to site staff on proper drug storage and handling procedures, including documentation requirements, temperature monitoring, and emergency procedures.
- Conduct regular audits: Conduct periodic audits of study sites to assess compliance with drug storage and handling procedures. Review storage facilities, documentation, and staff training records to identify any deviations from the protocol.
- Implement corrective actions: If any deviations from the protocol are identified during audits or inspections, promptly implement corrective actions to address the issues and ensure compliance.
- Monitor compliance with dispensing procedures: Ensure that the study drug is dispensed to participants according to the protocol-specified procedures, including verification of participant identity, accurate dosing, and do… Read full answer
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