SOCRA CCRP Data Management 2 — Questions and Answers
Question 1: What is the purpose of a Data Safety Monitoring Board (DSMB)?
- To manage the trial's financial budget
- To independently review accumulating trial data to protect subject safety and trial integrity (Correct answer)
- To audit the sponsor's data management systems
- To train site staff on data entry procedures
Correct answer: To independently review accumulating trial data to protect subject safety and trial integrity
A DSMB is an independent committee that periodically reviews accumulating data to assess safety, efficacy, and trial conduct, with authority to recommend stopping the trial.
Question 2: In the context of CDISC standards, what does CDASH stand for?
- Clinical Data Acquisition Standards Harmonization (Correct answer)
- Clinical Data Analysis and Summary Handbook
- Comprehensive Drug and Subject History
- Clinical Database Audit and Safety Hierarchy
Correct answer: Clinical Data Acquisition Standards Harmonization
CDASH (Clinical Data Acquisition Standards Harmonization) provides standards for collecting clinical trial data in CRFs to enable consistent data capture.
Question 3: What is database lock in a clinical trial?
- Encrypting the database to prevent hacking
- The process of finalizing the clinical database after all data issues are resolved, preventing further changes (Correct answer)
- A regulatory hold placed on a database by FDA
- Archiving old study databases
Correct answer: The process of finalizing the clinical database after all data issues are resolved, preventing further changes
Database lock is the final step in data management where all queries are resolved and the database is locked against further changes before statistical analysis.
Question 4: What does 'data validation' mean in clinical trial management?
- Confirming subject eligibility
- Checking data for completeness, consistency, and accuracy against predefined rules (Correct answer)
- Validating IRB approval documents
- Ensuring sponsor financial data is correct
Correct answer: Checking data for completeness, consistency, and accuracy against predefined rules
Data validation in clinical trials involves programmatic or manual checks to identify data errors, inconsistencies, or missing values against validation rules.
Question 5: Under GCP, which of the following best describes a 'certified copy'?
- A notarized photocopy of any document
- A verified copy that has the same information as the original and is confirmed by a dated signature (Correct answer)
- A document stamped by the FDA
- An electronic backup of paper records
Correct answer: A verified copy that has the same information as the original and is confirmed by a dated signature
A certified copy is a copy verified to have the same information as the original, confirmed as such by a dated signature, and is acceptable in place of the original.
Question 6: What is 'blinded data review' in clinical research?
- Reviewing data without subject identifiers
- Reviewing and cleaning data before treatment allocation codes are revealed (Correct answer)
- A data review conducted by an independent auditor
- Reviewing only placebo arm data
Correct answer: Reviewing and cleaning data before treatment allocation codes are revealed
Blinded data review involves reviewing and resolving data issues before breaking the randomization code to prevent bias in data cleaning decisions.
SOCRA CCRP Data Management 2
What is the purpose of a Data Safety Monitoring Board (DSMB)?