SOCRA CCRP Data Management 2

Question 1

What is the purpose of a Data Safety Monitoring Board (DSMB)?

Accepted Answer

To independently review accumulating trial data to protect subject safety and trial integrity

Answer

To manage the trial's financial budget

Answer

To audit the sponsor's data management systems

Answer

To train site staff on data entry procedures

Question 2

In the context of CDISC standards, what does CDASH stand for?

Accepted Answer

Clinical Data Acquisition Standards Harmonization

Answer

Clinical Data Analysis and Summary Handbook

Answer

Comprehensive Drug and Subject History

Answer

Clinical Database Audit and Safety Hierarchy

Question 3

What is database lock in a clinical trial?

Accepted Answer

The process of finalizing the clinical database after all data issues are resolved, preventing further changes

Answer

Encrypting the database to prevent hacking

Answer

A regulatory hold placed on a database by FDA

Answer

Archiving old study databases

Question 4

What does 'data validation' mean in clinical trial management?

Accepted Answer

Checking data for completeness, consistency, and accuracy against predefined rules

Answer

Confirming subject eligibility

Answer

Validating IRB approval documents

Answer

Ensuring sponsor financial data is correct

Question 5

Under GCP, which of the following best describes a 'certified copy'?

Accepted Answer

A verified copy that has the same information as the original and is confirmed by a dated signature

Answer

A notarized photocopy of any document

Answer

A document stamped by the FDA

Answer

An electronic backup of paper records

Question 6

What is 'blinded data review' in clinical research?

Accepted Answer

Reviewing and cleaning data before treatment allocation codes are revealed

Answer

Reviewing data without subject identifiers

Answer

A data review conducted by an independent auditor

Answer

Reviewing only placebo arm data