Statistics Regulatory Frameworks & Compliance 2 — Questions and Answers
Question 1: Which federal agency oversees the collection and dissemination of official U.S. economic statistics?
- Bureau of Labor Statistics
- Federal Reserve
- Office of Management and Budget (Correct answer)
- Census Bureau
Correct answer: Office of Management and Budget
The Office of Management and Budget (OMB) sets statistical policy and standards for all federal statistical agencies.
Question 2: Under OMB Statistical Policy Directive No. 1, federal agencies must ensure that statistical data are:
- Available only to Congress
- Relevant, accurate, and timely (Correct answer)
- Classified until peer-reviewed
- Collected solely by the Census Bureau
Correct answer: Relevant, accurate, and timely
OMB Directive No. 1 requires federal statistical agencies to produce data that meet standards of relevance, accuracy, and timeliness.
Question 3: What is the primary purpose of the Confidential Information Protection and Statistical Efficiency Act (CIPSEA)?
- Mandate data sharing between all federal agencies
- Protect individually identifiable data collected for statistical purposes (Correct answer)
- Require public disclosure of all survey microdata
- Establish criminal penalties for statistical fraud
Correct answer: Protect individually identifiable data collected for statistical purposes
CIPSEA protects the confidentiality of data collected under a pledge of confidentiality for statistical purposes.
Question 4: In clinical trial statistics, which regulatory body requires pre-registration of trial protocols to prevent outcome switching?
- SEC
- FDA (Correct answer)
- FTC
- EPA
Correct answer: FDA
The FDA, along with ClinicalTrials.gov requirements, mandates pre-registration to ensure primary outcomes are defined before data collection.
Question 5: The 'safe harbor' method under HIPAA allows de-identification of health data by removing how many specific identifiers?
- 10
- 14
- 18 (Correct answer)
- 22
Correct answer: 18
HIPAA's safe harbor method requires removal of 18 specific identifiers to consider protected health information de-identified.
Question 6: Which principle requires that statistical methods used in regulatory submissions be clearly documented so results can be independently reproduced?
- Parsimony
- Reproducibility (Correct answer)
- Sufficiency
- Ergodicity
Correct answer: Reproducibility
Reproducibility ensures that another analyst following the same documented methods would arrive at the same statistical conclusions.
Question 7: Under ICH E9 guidelines for pharmaceutical statistics, what is the 'estimand'?
- The estimated sample size needed
- A precise description of the treatment effect to be estimated (Correct answer)
- The algorithm used to handle missing data
- The regulatory threshold for statistical significance
Correct answer: A precise description of the treatment effect to be estimated
An estimand is a precise specification of the clinical question to be answered, including population, variable, and intercurrent event handling.
Statistics Regulatory Frameworks & Compliance 2
Which federal agency oversees the collection and dissemination of official U.S. economic statistics?