{ "_id": "6a1f2dbbb401979e7342683d", "Package": "r4subdata", "Title": "Example Datasets for Clinical Submission Readiness", "Version": "0.1.2", "Authors@R": "person(\"Pawan Rama\", \"Mali\", email = \"prm@outlook.in\",\nrole = c(\"aut\", \"cre\", \"cph\"),\ncomment = c(ORCID = \"0000-0001-7864-5819\"))", "Description": "Provides realistic synthetic example datasets for the\nR4SUB (R for Regulatory Submission) ecosystem. Includes a\npharma study evidence table, ADaM (Analysis Data Model) and\nSDTM (Study Data Tabulation Model) metadata following CDISC\n(Clinical Data Interchange Standards Consortium) conventions\n(), traceability mappings, a risk\nregister based on ICH (International Council for Harmonisation)\nQ9 quality risk management principles\n(), and regulatory\nindicator definitions. 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