Q1
Walk us through your experience with EDC (Electronic Data Capture) systems. Which platforms have you used, and how did you handle data validation rules and edit checks in those systems?
Why they ask this:* EDC systems are core to clinical data management; they want to assess hands-on proficiency with industry-standard tools and your ability to implement quality controls.
Q2
Describe your experience with GCP (Good Clinical Practice) guidelines and ICH-E6(R2) requirements. How have you ensured compliance in previous roles, particularly regarding data integrity and audit trails?
Why they ask this:* Regulatory compliance is non-negotiable in clinical trials; they're evaluating your understanding of legal and ethical frameworks that govern clinical data.
Q3
You're reviewing a dataset and notice 15% of patients have missing values in a critical efficacy endpoint. What statistical and operational approaches would you use to investigate root causes and determine if the data is recoverable?
Why they ask this:* This tests your analytical thinking, knowledge of data quality standards, and ability to balance pragmatism with regulatory requirements in real-world scenarios.
Q4
Tell us about your experience with SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) standards. How have you applied these in preparing datasets for statistical analysis or regulatory submissions?