R Programming Language Certification Regulatory Frameworks & Compliance 4 — Questions and Answers
Question 1: Which R function from the haven package correctly exports a data frame to SAS Transport format for an FDA regulatory submission?
- write_xpt() (Correct answer)
- write_sas()
- export_xpt()
- save_transport()
Correct answer: write_xpt()
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?
- Software validation and verification of analysis tools (Correct answer)
- Open publication of source code
- Mandatory use of cloud computing infrastructure
- Automatic code formatting with styler
Correct answer: Software validation and verification of analysis tools
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?
- CLIA and HIPAA combined retention requirements (Correct answer)
- Open Data Charter
- Creative Commons licensing
- R Consortium code of ethics
Correct answer: CLIA and HIPAA combined retention requirements
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?
- Collecting and retaining only the data strictly necessary for the specified purpose (Correct answer)
- Compressing all datasets to minimize file size
- Removing all missing values before analysis
- Using the minimum number of R packages possible
Correct answer: Collecting and retaining only the data strictly necessary for the specified purpose
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?
- Validation Summary Report (VSR) (Correct answer)
- README file
- DESCRIPTION file
- NEWS changelog
Correct answer: Validation Summary Report (VSR)
A Validation Summary Report documents the scope, test results, and conclusions of package validation activities, providing the formal evidence required by GxP regulations.
Question 6: Which R Consortium working group has published guidance specifically on using R in regulated clinical trial environments?
- R Validation Hub (Correct answer)
- R-Ladies
- Bioconductor Core Team
- CRAN Task Force
Correct answer: R Validation Hub
The R Validation Hub is an R Consortium working group that has produced the white paper 'A Risk-Based Approach for Assessing R Package Accuracy within a Validated Infrastructure.'
Question 7: Under the EU AI Act, R-based predictive models used in hiring decisions would likely be classified under which risk category?
- High-risk (Correct answer)
- Unacceptable risk
- Minimal risk
- Limited risk
Correct answer: High-risk
The EU AI Act classifies AI systems used in employment and worker management, including recruitment and evaluation, as high-risk, requiring conformity assessments and documentation.
R Programming Language Certification Regulatory Frameworks & Compliance 4
Which R function from the haven package correctly exports a data frame to SAS Transport format for an FDA regulatory submission?