R Programming Language Certification Regulatory Frameworks & Compliance 2

Question 1

Under GDPR, what R package function is most appropriate for anonymizing a dataset before sharing it with a third party?

Accepted Answer

sdcMicro::anonymize()

Answer

The sdcMicro package provides statistical disclosure control methods specifically designed to anonymize data in compliance with privacy regulations like GDPR.

Question 2

Which principle of the FDA 21 CFR Part 11 regulation directly governs the use of electronic records produced by R scripts in clinical trials?

Accepted Answer

Audit trail integrity

Answer

FDA 21 CFR Part 11 requires that electronic records maintain audit trails that document the creation, modification, and deletion of records to ensure data integrity.

Question 3

A pharmaceutical company uses R for statistical analysis in a submission to the EMA. Which file format is required for submitting analysis datasets?

Accepted Answer

SAS Transport (.xpt)

Answer

The EMA and FDA require clinical trial analysis datasets to be submitted in SAS Transport format (.xpt), which R can write using the haven or SASxport packages.

Question 4

Which R package is the industry standard for creating CDISC-compliant ADaM datasets used in regulatory submissions?

Accepted Answer

admiral

Answer

The admiral package, maintained by a pharma industry consortium, provides a toolkit for creating ADaM (Analysis Data Model) datasets conforming to CDISC standards.

Question 5

Under HIPAA's Safe Harbor method, how many specific identifiers must be removed from a dataset for it to be considered de-identified?

Accepted Answer

18

Answer

HIPAA's Safe Harbor method requires the removal of 18 specific patient identifiers, such as names, dates, and geographic data finer than state level.

R Programming Language Certification Practice Test

R Programming Language Certification Practice Test

R Programming Language Certification Regulatory Frameworks & Compliance 2