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.
Time-to-Event CRM (TITE-CRM)
A computational guide to the Time-to-Event Continual Reassessment Method (TITE-CRM), including partial follow-up weighting, Bayesian dose-toxicity modeling, posterior updating, dose assignment, operating considerations, and a complete worked example.
Time-to-Event BOIN (TITE-BOIN) Part 2: Case Study
A complete worked case study of the Time-to-Event Bayesian Optimal Interval (TITE-BOIN) design, following a hypothetical Phase I oncology trial from the first cohort through MTD selection using pending DLT information and standardized total follow-up time.
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.
Survival Analysis in R: The survival Package
A practical guide to survival analysis in R using the survival package, including time-to-event data, censoring, Kaplan-Meier curves, log-rank tests, Cox proportional hazards models, hazard ratios, confidence intervals, model interpretation, diagnostics, clinical trial applications, and reproducible R workflows.
Simulating Clinical Trial Data in R
A practical guide to simulating realistic clinical trial data in R, including treatment assignment, baseline covariates, longitudinal endpoints, binary and time-to-event outcomes, missing data, dropout, treatment effects, reproducible simulation, Monte Carlo operating characteristics, and validation.
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.
SAS vs. R for CDISC Programming
A practical guide comparing SAS and R for CDISC programming, including SDTM, ADaM, controlled terminology, derivations, validation, transport files, Define-XML, regulatory submission workflows, reproducibility, and production programming.
SAS PROC REPORT for TLF Development
A practical guide to SAS PROC REPORT for clinical trial Tables, Listings, and Figures, including report columns, ACROSS variables, COMPUTE blocks, BREAK and RBREAK statements, spanning headers, ODS RTF and PDF output, formatting, pagination, and production TLF programming patterns.