eCTD and Electronic Submission Requirements
A practical guide to eCTD and electronic regulatory submission requirements, including CTD modules, eCTD architecture, sequences, lifecycle management, XML backbones, PDF requirements, hyperlinks, bookmarks, validation, FDA requirements, eCTD v4.0, EU requirements, submission gateways, and regulatory submission QC.
admiralonco Part 2: Advanced Oncology ADaM Programming
An advanced practical guide to oncology ADaM programming with admiralonco, covering ADRS, ADTR, ADTTE, response criteria, confirmation logic, event derivation, reusable programming patterns, validation, and production-quality R workflows.
admiral R Package: Getting Started
An advanced guide to the admiral R package for statistical programmers, covering ADSL, BDS, OCCDS, joins, baseline, change, computed parameters, treatment-emergent flags, reusable derivations, testing, traceability, and QC.
Validating CDISC Datasets with Pinnacle 21
An advanced practical guide to validating CDISC SDTM, ADaM, and Define-XML datasets with Pinnacle 21, including validation strategy, findings interpretation, severity, controlled terminology, metadata, false positives, CLI automation, QC, and regulatory submission readiness.
Therapeutic Area User Guides (TAUGs) Overview
A practical guide to CDISC Therapeutic Area User Guides (TAUGs), including their purpose, relationship to CDASH, SDTM, ADaM and controlled terminology, concept maps, annotated CRFs, disease-specific metadata, TA Specifications, implementation workflows, versioning, traceability, and common implementation pitfalls.
SDTM to ADaM Traceability Best Practices
A practical, advanced guide to SDTM-to-ADaM traceability, covering dataset, variable, record, derivation, metadata, programming, validation, audit trails, examples, traceability matrices, and regulatory-ready documentation.
SDTM Basics for Clinical Programmers
A practical guide to SDTM basics for clinical programmers, including CDISC concepts, observation classes, domains, variables, controlled terminology, timing, mapping, SUPPQUAL, RELREC, traceability, validation, Define-XML, and SAS implementation.
RECIST 1.1 Endpoints in ADaM Datasets
An advanced guide to representing RECIST 1.1 oncology endpoints in ADaM datasets, including overall response, best overall response, objective response rate, duration of response, time to response, progression-free survival, response derivation, BDS structures, ADTTE, traceability, programming examples, and validation.
Introduction to CDISC Standards
A practical introduction to CDISC standards for clinical trials, covering CDASH, SDTM, ADaM, Define-XML, controlled terminology, therapeutic-area standards, traceability, regulatory submissions, implementation workflows, and practical programming examples.
Handling Multiple Visits in SDTM
A practical guide to handling multiple visits in SDTM, including scheduled and unscheduled visits, VISIT, VISITNUM, VISITDY, study day, Subject Visits, repeated assessments, multi-day visits, visit windows, treatment cycles, mapping strategies, programming examples, R and SAS implementation, and validation.