How do you handle discrepancies or deviations in clinical trial data?

Your Answer

How To Answer This Question?

When answering this question, it's important to demonstrate your ability to identify, investigate, and resolve discrepancies or deviations in clinical trial data. Start by explaining the importance of data integrity and compliance with regulatory requirements. Provide a step-by-step approach to how you would handle such situations, including:

1. Identification: Describe how you would identify discrepancies or deviations, such as through regular data reviews or monitoring visits.
2. Investigation: Explain how you would investigate the root cause of the issue, which may involve reviewing source documents, querying the site, or discussing with the clinical team.
3. Resolution: Detail the steps you would take to resolve the issue, such as correcting the data, retraining site staff, or implementing corrective and preventive actions (CAPA).
4. Documentation: Emphasize the importance of documenting all findings, actions taken, and communications to ensure transparency and compliance.
5. Communication: Highlight the need to communicate effectively with all stakeholders, including the site, sponsor, and regulatory authorities, to ensure the issue is resolved and prevented in the future.

Provide examples from your past experience where possible to illustrate your approach and effectiveness in handling such situations.