CATO Associate Data Management & Reporting Flashcards
6 cards from real CCA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CATO Associate Data Management & Reporting flashcards as text
What is the main role of a clinical data manager?
Answer: Ensure data accuracy and integrity
Clinical data managers are responsible for collecting, validating, and managing trial data to ensure accuracy and compliance.
Which system is commonly used for electronic data capture in clinical trials?
Answer: EDC system
EDC (Electronic Data Capture) systems like Medidata and Oracle Clinical help streamline data entry and validation.
What is a data query in clinical trials?
Answer: A request to correct or clarify data
A data query is a request to clarify or correct discrepancies found in the collected data.
What ensures clinical data is traceable and auditable?
Answer: Audit trail
An audit trail logs all changes made to data, providing transparency and traceability required by regulations.
What is the Clinical Study Report (CSR)?
Answer: Clinical Study Report
The CSR is a comprehensive report of the trial’s methodology, results, and conclusions submitted to regulatory bodies.
What step follows data lock in a clinical trial?
Answer: Statistical analysis
After data lock, statistical analysis is conducted to interpret the study findings.