Statistics Regulatory Frameworks & Compliance 2

Question 1

Which federal agency oversees the collection and dissemination of official U.S. economic statistics?

Accepted Answer

Office of Management and Budget

Answer

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:

Accepted Answer

Relevant, accurate, and timely

Answer

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)?

Accepted Answer

Protect individually identifiable data collected for statistical purposes

Answer

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?

Accepted Answer

FDA

Answer

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?

Accepted Answer

18

Answer

HIPAA's safe harbor method requires removal of 18 specific identifiers to consider protected health information de-identified.

Statistics Practice Test