Sample interview questions: How do you ensure that your writing is compliant with the principles of good clinical practice (GCP) when dealing with clinical research involving human subjects?
Sample answer:
- Adherence to GCP Guidelines: Familiarize yourself thoroughly with GCP guidelines such as the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
- Institutional Review Board (IRB) Approval: Ensure that all clinical research involving human subjects has received approval from an accredited IRB. Review the IRB-approved protocol and adhere to its requirements for subject recruitment, data collection, and reporting.
- Informed Consent: Obtain informed consent from participants in accordance with GCP principles. Provide clear and comprehensive information about the study, including its purpose, risks, benefits, and participants’ rights.
- Confidentiality and Data Protection: Maintain strict confidentiality of all participant data. Comply with applicable data protection regulations and ensure appropriate data storage and security measures are in place.
- Accurate and Transparent Reporting: Report clinical research data accurately and transparently. Follow GCP guidelines for data c… Read full answer
Source: https://hireabo.com/job/2_3_15/Medical%20Writer