Sample interview questions: How do you handle any unforeseen complications that may arise during a clinical study?
Sample answer:
Unforeseen Complications in Clinical Studies
1. Patient Safety
* Prioritize patient well-being and adhere to ethical guidelines.
* Implement safety measures and protocols to mitigate risks.
* Report any adverse events promptly to relevant authorities.
2. Regulatory Compliance
* Ensure adherence to FDA, IRB, and other regulatory requirements.
* Obtain timely approvals for protocol modifications and safety concerns.
* Maintain accurate and complete documentation to facilitate audits and inspections.
3. Study Protocol Modifications
* Communicate changes to participants, investigators, and regulatory bodies.
* Obtain necessary approvals and revise study materials accordingly.
* Monitor the impact of modifications on study outcomes.
4. Data Management
* Safeguard patient data and maintain confidentiality.
* Implement robust data collection and analysis plans.
* Manage and resolve technical issues related to data collection and storage.
5. Participant Retention
* Establish effective communication channels with p… Read full answer
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