Tag: ADRG

Estimands → Outputs Traceability: Keep the Thread Intact

Posted on digi By digi

Estimands → Outputs Traceability: Keep the Thread Intact Keeping the Estimands → Outputs Thread Intact: A Practical Traceability Playbook Why estimand-to-output traceability is the backbone of inspection readiness The “thread” reviewers try to pull When regulators open your submission, they will try to pull a single thread: “From the stated estimand, can I travel—quickly and…

Read More “Estimands → Outputs Traceability: Keep the Thread Intact” »

Biostats, CDISC & Traceability, Clinical Trial Operations & Data Integrity

MedDRA/WHODrug & Footnotes: Version Control That’s Traceable

Posted on digi By digi

MedDRA/WHODrug & Footnotes: Version Control That’s Traceable Make MedDRA/WHODrug Version Control Traceable: Footnotes, Change Logs, and Evidence That Survive Review Why dictionary version control is a regulatory deliverable (not just a data-management task) What “traceable” means for coded data When reviewers challenge an adverse event count or a concomitant medication pattern, they are really testing…

Read More “MedDRA/WHODrug & Footnotes: Version Control That’s Traceable” »

Biostats, CDISC & Traceability, Clinical Trial Operations & Data Integrity

SDTM → ADaM Mapping: Inputs, Outputs, Test Cases (US/UK Reviewers)

Posted on digi By digi

SDTM → ADaM Mapping: Inputs, Outputs, Test Cases (US/UK Reviewers) SDTM to ADaM Mapping That Survives Review: Inputs, Outputs, and Test Cases for US/UK Regulators Why SDTM→ADaM mapping is the fulcrum of inspection-readiness What “defensible mapping” really means Defensible mapping is the ability to pick any number in an analysis output and travel—quickly and repeatably—back…

Read More “SDTM → ADaM Mapping: Inputs, Outputs, Test Cases (US/UK Reviewers)” »

Biostats, CDISC & Traceability, Clinical Trial Operations & Data Integrity

Figure Standards That Stick: Labels, Ordering, Color Rules

Posted on digi By digi

Figure Standards That Stick: Labels, Ordering, Color Rules Figure Standards That Stick: Making Labels, Ordering, and Color Rules Reproducible and Reviewer-Friendly Why “figure standards” are a regulatory deliverable—not just a style preference Figures drive first impressions and hard questions For many reviewers, your figures are the first contact with the analysis, so they must answer…

Read More “Figure Standards That Stick: Labels, Ordering, Color Rules” »

Biostats, CDISC & Traceability, Clinical Trial Operations & Data Integrity

TLF Shells That Align Teams: Templates, Titles, Footnotes

Posted on digi By digi

TLF Shells That Align Teams: Templates, Titles, Footnotes TLF Shells That Align Teams: How to Design Templates, Titles, and Footnotes Everyone Can Defend Outcome-first TLF shells: align science, statistics, and inspection in one artifact What the shell must prove on Day 1 Well-made TLF shells do three jobs simultaneously: they communicate analysis intent to programmers…

Read More “TLF Shells That Align Teams: Templates, Titles, Footnotes” »

Biostats, CDISC & Traceability, Clinical Trial Operations & Data Integrity