CATO Associate Data Management & Reporting 1

Question 1

What is the main role of a clinical data manager?

Accepted Answer

Ensure data accuracy and integrity

Answer

Clinical data managers are responsible for collecting, validating, and managing trial data to ensure accuracy and compliance.

Question 2

Which system is commonly used for electronic data capture in clinical trials?

Accepted Answer

EDC system

Answer

EDC (Electronic Data Capture) systems like Medidata and Oracle Clinical help streamline data entry and validation.

Question 3

What is a data query in clinical trials?

Accepted Answer

A request to correct or clarify data

Answer

A data query is a request to clarify or correct discrepancies found in the collected data.

Question 4

What ensures clinical data is traceable and auditable?

Accepted Answer

Audit trail

Answer

An audit trail logs all changes made to data, providing transparency and traceability required by regulations.

Question 5

What is the Clinical Study Report (CSR)?

Accepted Answer

Clinical Study Report

Answer

The CSR is a comprehensive report of the trial’s methodology, results, and conclusions submitted to regulatory bodies.

(CCA) CATO Certified Associate Practice Test