Package: r4subrisk Title: Risk Quantification Engine for Clinical Submission Readiness Version: 0.1.1 Authors@R: person("Pawan Rama", "Mali", email = "prm@outlook.in", role = c("aut", "cre", "cph"), comment = c(ORCID = "0000-0001-7864-5819")) Description: Quantifies submission risk using a Failure Modes and Effects Analysis (FMEA)-inspired framework (probability, impact, detectability). Builds risk registers from evidence, computes Risk Priority Numbers (RPN), classifies risk levels, and emits standardized R4SUB (R for Regulatory Submission) evidence table rows via 'r4subcore'. Supports risk mitigation tracking and trend analysis across submission milestones. License: MIT + file LICENSE URL: https://r4sub.github.io/r4subrisk/, https://github.com/R4SUB/r4subrisk BugReports: https://github.com/R4SUB/r4subrisk/issues Depends: R (>= 4.2) Imports: cli, dplyr, r4subcore, rlang, tibble Suggests: knitr, rmarkdown, testthat (>= 3.0.0) VignetteBuilder: knitr Config/testthat/edition: 3 Encoding: UTF-8 Roxygen: list(markdown = TRUE) RoxygenNote: 7.3.3 Config/pak/sysreqs: libxml2-dev Repository: https://r4sub.r-universe.dev Date/Publication: 2026-03-16 11:27:50 UTC RemoteUrl: https://github.com/r4sub/r4subrisk RemoteRef: HEAD RemoteSha: 921e527ff3d0ccac058c4175282a68f9f62388de NeedsCompilation: no Packaged: 2026-06-19 09:50:32 UTC; root Author: Pawan Rama Mali [aut, cre, cph] (ORCID: ) Maintainer: Pawan Rama Mali