27 References
Sources cited in this book, with status notes. External sources were verified by direct retrieval during the book’s literature survey (October 2026); the author’s own works are listed with their public locations. Minimal-claim citations (named standards not re-fetched during the survey) are marked.
27.1 Regulations and guidance
- FDA. Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application. September 2003. fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application [full text read during survey]
- FDA. Statistical Software Clarifying Statement. 2015. [cited at minimal-claim level via R2]
- ISPE. GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, 2nd edition. 2022. [minimal-claim citation; standard not re-fetched during survey]
- European Commission. EudraLex Volume 4, Annex 11: Computerised Systems. [minimal-claim citation]
27.2 Validation and open-source literature
- Nicholls, A., Bargo, P. R., Sims, J., and the R Validation Hub. A Risk-based Approach for Assessing R package Accuracy within a Validated Infrastructure. White paper, 2020 (updated). pharmar.org/white-paper [full text read during survey]
- R Validation Hub. Site, tooling ({riskmetric}, {riskassessment}, {riskscore}), Regulatory Repository initiative, and case studies including SCHARP’s study-specific risk assessment (PHUSE US Connect 2026). pharmar.org [read during survey]
- PHUSE Data Visualisation & Open Source Technology Working Group. Open Source Technology in Clinical Data Analysis (OSTCDA) guidance. [engaged as cited in the author’s A2 manuscript; chapters 5 and 15 open as of that engagement]
27.3 Ecosystems and tooling
- pharmaverse. Site, package catalog, charter, and FAQ. pharmaverse.org [read during survey]
- Insights Engineering. NEST: rtables, tern, rlistings, teal, formatters, scda, TLG Catalog, and project timeline. insightsengineering.github.io/nest [read]
- Landau, W. The {targets} R Package User Manual. rOpenSci. books.ropensci.org/targets [read during survey]
- Chen, T. Y., Cheung, S. C., and Yiu, S. M. Metamorphic Testing: A New Approach for Generating Next Test Cases. Technical Report HKUST-CS98-01, Hong Kong University of Science and Technology, 1998. [bibliographic record verified]
- pharmaverse cards/cardx (Analysis Results Data). pharmaverse.github.io/cards [existence verified]
- PHUSE/pharmaverse listed packages referenced collectively: admiral, metacore, metatools, rtables, tern, rlistings, Tplyr, tfrmt, teal, siera, autoslider, logrx, covtracer, risk.assessr, valtools, whirl, envsetup, pkglite, xportr, pharmaverseadam, pharmaversesdtm, datasetjson, rtflite. [catalog verified via pharmaverse.org]
- SAS Life Science Analytics Framework; Posit Workbench / Package Manager / Connect. [commercial landscape, minimal-claim citations]