pkglite

pkglite converts R code and R packages into a compact, text-based representation for packaging analysis scripts, package code, and dependencies for inclusion and traceability in electronic Common Technical Document (eCTD) regulatory submissions.

Key Features:

• eCTD integration: Converts analysis scripts and their dependencies into a compact, text-based format suitable for inclusion in electronic Common Technical Document (eCTD) submissions.
• Dependency packaging: Packs and unpacks multiple R packages along with their dependencies to preserve reproducible computational environments.
• File specification and traceability: Uses a grammar of file specifications to record explicit packing scope and enable traceability of files included in a submission.
• Open text-based format: Represents and exchanges R packages in an open, text-based file format to support interoperability and standardization.

Scientific Applications:

• eCTD submission packaging: Organizes R scripts, package code, and dependencies into a self-contained representation for sponsors and reviewers within eCTD frameworks.
• Regulatory submission use case: Has been applied in an R-based submission to the US Food and Drug Administration by the R Consortium R Submission Working Group.

Methodology:

pkglite serializes and converts R scripts and package files into a compact text-based representation, packs and unpacks R packages with their dependencies, and encodes file selection via a grammar of file specifications to produce an open text format for exchange.