Tables, Listings & Figures Production
Turn analysis data into accurate, readable evidence
Build, QC and release a complete set of publication- and submission-grade displays from ADaM.
Final shells, SAP, validated ADaM and output specifications
QC-approved TLF package, output metadata and release manifest
Real course content
9 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
TLF fundamentals
Shells and mock-ups, titles/footnotes/population lines, rounding rules, the output-to-SAP trace, and output formats.
Chapter 1 of 9
Demographics & baseline characteristics
The Table 14.1.x everyone knows: continuous and categorical summaries, by-arm and total columns, in SAS & R.
Chapter 2 of 9
Disposition
Subject accounting, screen-fail and discontinuation reasons, population attrition, and a CONSORT-style figure.
Chapter 3 of 9
Exposure & treatment compliance
Duration of exposure, dose intensity, compliance summaries, and handling interruptions.
Chapter 4 of 9
Concomitant medications
Summaries by WHODrug ATC class and PT, prior vs concomitant, sorting by frequency.
Chapter 5 of 9
Efficacy — primary, secondary & exploratory endpoints
The heart of the CSR: the primary endpoint table with model output, secondary/exploratory endpoints, subgroups.
Chapter 6 of 9
Safety — adverse events
AE overview, TEAEs by SOC/PT, severity and relationship, SAEs and deaths, by-arm incidence.
Chapter 7 of 9
Safety — labs, vitals & ECG
Shift tables, change-from-baseline, markedly-abnormal and toxicity grades, and the Hy’s law scatter.
Chapter 8 of 9
Listings & figures
Patient listings, Kaplan–Meier curves, mean-over-time plots, forest plots, and figure standards.
Chapter 9 of 9