R Programming Language Certification Regulatory Frameworks & Compliance 4

Question 1

Which R function from the haven package correctly exports a data frame to SAS Transport format for an FDA regulatory submission?

Accepted Answer

write_xpt()

Answer

haven::write_xpt() writes a data frame to the SAS Transport (.xpt) format required by FDA and EMA for CDISC dataset submissions.

Question 2

Under ISO 13485 (medical devices), what quality management requirement most directly applies to R scripts used in device performance analysis?

Accepted Answer

Software validation and verification of analysis tools

Answer

ISO 13485 requires validation and verification of software used in quality management, meaning R scripts and their underlying packages must be tested and documented before use.

Question 3

A regulated lab uses R to process patient genomic data. Which framework most directly governs how long that data must be retained?

Accepted Answer

CLIA and HIPAA combined retention requirements

Answer

Clinical laboratory testing of patient samples is governed by CLIA, while the resulting identifiable health data retention is governed by HIPAA, and both apply simultaneously.

Question 4

What does the concept of 'data minimization' require when building an R pipeline that processes personal data under GDPR?

Accepted Answer

Collecting and retaining only the data strictly necessary for the specified purpose

Answer

GDPR's data minimization principle requires that personal data collected and processed be adequate, relevant, and limited to what is necessary for the stated purpose.

Question 5

In a validated R environment for GxP use, what document formally establishes that an R package performs as intended for its regulatory purpose?

Accepted Answer

Validation Summary Report (VSR)

Answer

A Validation Summary Report documents the scope, test results, and conclusions of package validation activities, providing the formal evidence required by GxP regulations.

R Programming Language Certification Practice Test

R Programming Language Certification Practice Test

R Programming Language Certification Regulatory Frameworks & Compliance 4