参考文献

本书引用的来源，附状态说明。外部来源均在本书文献综述期间(2026 年 10 月)经直接检索核验；作者本人的作品以其公开位置列出。最小声明级引用(综述期间未重新抓取的具名标准)已标注。

法规与指南

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 [综述期间已读全文]
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. [最小声明级引用；综述期间未重新抓取该标准]
European Commission. EudraLex Volume 4, Annex 11: Computerised Systems. [最小声明级引用]

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 [综述期间已读全文]
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 [综述期间已读]
PHUSE Data Visualisation & Open Source Technology Working Group. Open Source Technology in Clinical Data Analysis (OSTCDA) guidance. [按其被引于作者 A2 手稿之状态接触；截至该次接触，第 5 章与第 15 章仍为开放]

pharmaverse. Site, package catalog, charter, and FAQ. pharmaverse.org [综述期间已读]
Insights Engineering. NEST: rtables, tern, rlistings, teal, formatters, scda, TLG Catalog, and project timeline. insightsengineering.github.io/nest [已读]
Landau, W. The {targets} R Package User Manual. rOpenSci. books.ropensci.org/targets [综述期间已读]
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. [书目记录已核验]
pharmaverse cards/cardx (Analysis Results Data). pharmaverse.github.io/cards [存在性已核验]
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. [目录已经 pharmaverse.org 核验]
SAS Life Science Analytics Framework; Posit Workbench / Package Manager / Connect. [商业版图，最小声明级引用]

Yan, J. Human-Governed Validation of R Packages for Regulated Statistical Computing: LLM-Assisted Specifications and Auditable Test Evidence. Preprint (submitted), 2026. jaimeyan.com/papers [配套论文；已读原文]
Yan, J. Beyond a Single Shiny Server: A Composable Docker Platform for Clinical Data Review at a Small Biotech. PHUSE paper draft, 2026. [已读原文；第 19 章之基础]
Yan, J. Who Validates What: A Two-Tier R Package Validation Strategy for a Fully Outsourced Biotech. PHUSE paper draft, 2026. [已读原文；第 20 章组织层之基础]
Yan, J. CAVE-Onc: Graph-Constrained Agentic Validation for Cross-Domain Contradictions in CDISC Oncology Submissions. PLOS One, 2026. doi:10.1371/journal.pone.0350376
Yan, J. ClinAgent: AI-Assisted Methodology for Clinical Trial Data Processing and Statistical Programming. Biology Methods and Protocols, 2026. doi:10.1093/biomethods/bpag032
Yan, J., Zhang, J. Eliminating QC Programming Duplication Through Claude AI-Assisted Independent Code Generation. PharmaSUG 2026 (AI-201). doi:10.5281/zenodo.22182922

第二部分背后的文献综述连同逐来源的核验状态，完整保存在本书源码仓库的 research/lit_review_gxp_sce.md 中。