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Clinical Programming AcademyRebuilt · July 2026

Clinical programming,
from protocol to reviewer.

An end-to-end, artifact-driven course built around one Phase 3 trial. Learn the decisions, code, metadata, quality gates and handoffs behind SDTM, ADaM, statistics, TLFs, safety, the CSR and a regulatory submission—not isolated definitions.

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11

connected modules

67

full instructional chapters

SAS + R

bilingual workflow

2026

regulatory baseline

The case that connects everything

CLIN-301: One Phase 3 trial from protocol to submission

A randomized, double-blind, placebo-controlled parallel-group study with a continuous primary endpoint, safety follow-up, central laboratory data, ECG, ePRO, and an independent DMC.

Primary endpoint

Change from baseline at Week 24, analyzed with MMRM under a treatment-policy estimand.

Learning loop

Understand → build → check → hand off. Every chapter ends with a worked application, deliverable, and assessment.

Core pathway

Modules 1–9: the complete study lifecycle

Each handoff becomes the governed input to the next module, so learners see how local choices affect the final submission.

1
Design & acquire 5–7 hours

Study Design, Documents & Data Acquisition

Understand the trial before touching a dataset

Translate the protocol, SAP, CRF and operational data flow into a programming-ready study blueprint.

0/5 gates0%
Start first chapter
Starts with: Protocol concept, endpoints and operational design
Hands off: Approved programming blueprint, source inventory and data-cut plan
1.1 The protocol — the contract for the trial1.2 The Statistical Analysis Plan (SAP)1.3 The Case Report Form (CRF)1.4 CRF annotation (aCRF)1.5 EDC, data flow & database lock
2
Engineer 5–7 hours

Production Programming Foundations

Make every result reproducible, reviewable and rerunnable

Operate a controlled SAS/R study environment with standards, automation, testing, review and release evidence.

0/5 gates0%
Start first chapter
Starts with: Programming blueprint and governed source snapshots
Hands off: Validated study repository and repeatable production pipeline
2.1 SAS in clinical — why it still rules submissions2.2 R in clinical — the pharmaverse era2.3 SAS ↔ R, side-by-side2.4 Programming standards & defensive code2.5 Version control, structure & documentation
3
Standardize 6–8 hours

CDISC Standards Strategy & Metadata

Choose and connect the standards before building datasets

Design a governed CDISC implementation from collection through tabulation, analysis metadata and submission documentation.

0/6 gates0%
Start first chapter
Starts with: Study blueprint, source inventory and corporate standards
Hands off: Approved standards plan, metadata model and implementation conventions
3.1 Why standards — the CDISC ecosystem3.2 CDASH — the collection standard3.3 The SDTM model3.4 The ADaM model3.5 Controlled terminology3.6 define.xml & the data package
4
Tabulate 8–12 hours

SDTM Mapping, Build & Submission Package

Turn heterogeneous sources into reviewer-friendly tabulation data

Specify, program, validate and document a complete SDTM package, including complex timing and non-CRF sources.

0/7 gates0%
Start first chapter
Starts with: Locked or governed source data, aCRF and SDTM metadata specification
Hands off: Validated SDTM XPT package, Define-XML inputs, aCRF and SDRG content
4.1 From aCRF to SDTM — the mapping mindset4.2 Special-purpose & demographics: DM4.3 Interventions domains: EX, CM, (EC)4.4 Events domains: AE, MH, DS4.5 Findings domains: LB, VS, EG4.6 Trial-design & relationship datasets4.7 Validating SDTM
5
Analyze 8–12 hours

ADaM Derivation, Traceability & Validation

Encode the SAP into analysis-ready data

Build a coherent ADaM suite that implements estimands, endpoints, populations and analysis decisions with reviewable traceability.

0/7 gates0%
Start first chapter
Starts with: Validated SDTM, SAP, analysis specs and study-level conventions
Hands off: Validated analysis datasets, Define-XML inputs, ARM inputs and ADRG content
5.1 ADaM principles in practice5.2 ADSL — the subject-level spine5.3 BDS I — ADVS (vital signs)5.4 BDS II — ADLB (labs)5.5 OCCDS — ADAE5.6 ADTTE — time-to-event5.7 ADaM define & validation
6
Report 8–12 hours

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.

0/9 gates0%
Start first chapter
Starts with: Final shells, SAP, validated ADaM and output specifications
Hands off: QC-approved TLF package, output metadata and release manifest
6.1 TLF fundamentals6.2 Demographics & baseline characteristics6.3 Disposition6.4 Exposure & treatment compliance6.5 Concomitant medications6.6 Efficacy — primary, secondary & exploratory endpoints6.7 Safety — adverse events6.8 Safety — labs, vitals & ECG6.9 Listings & figures
7
Model 7–10 hours

Statistics for Clinical Programmers

Understand the statistical decisions your code operationalizes

Implement common clinical analyses faithfully, diagnose model problems and explain the result path to reviewers.

0/6 gates0%
Start first chapter
Starts with: Estimands, analysis populations, validated ADaM and statistical methods
Hands off: Verified model results, diagnostics, sensitivity analyses and analysis audit trail
7.1 Analysis populations & estimands7.2 Descriptive stats & CIs done right7.3 Common efficacy models7.4 Survival analysis7.5 Multiplicity & interim analyses7.6 Missing data & sensitivity analyses
8
Protect 6–9 hours

Safety Programming & Pharmacovigilance

Reconcile, monitor and communicate risk without breaking the blind

Support SAE reconciliation, aggregate safety review, committees, narratives and safety reporting with governed data cuts.

0/6 gates0%
Start first chapter
Starts with: Clinical data, safety-system cases, exposure, coding dictionaries and reporting calendar
Hands off: Reconciled safety data, committee packages, aggregate-report feeds and narrative datasets
8.1 The safety data landscape8.2 SAE processing & reconciliation8.3 DMC / DSMB deliverables8.4 Safety Review Committees (SRC) & signal detection8.5 Aggregate safety reports8.6 Deaths, SAEs & narratives feed
9
Submit & sustain 7–10 hours

CSR, Submission Package & Regulatory Lifecycle

Connect final results to documents, eCTD and reviewer questions

Assemble the programming contribution to a CSR and standardized study-data submission, pass readiness checks and support agency review.

0/5 gates0%
Start first chapter
Starts with: Final TLFs, SDTM/ADaM packages, metadata, reviewer guides and QC evidence
Hands off: CSR appendices and validated eCTD Module 5 study-data package with archived provenance
9.1 The document ecosystem9.2 The Clinical Study Report (ICH E3)9.3 Investigator’s Brochure (IB)9.4 DSUR & interim reporting9.5 Patient narratives

Advanced completion

Integration and capstone

10
Integrate & submit 8–12 hours

Integrated Evidence & Submission Engineering

Scale from one study to a reviewable application

Plan and deliver pooled safety/efficacy data, integrated analyses and a technically conformant multi-study submission.

0/5 gates0%
Start first chapter
Starts with: Final study packages, portfolio standards, integration SAP and submission plan
Hands off: Validated integrated data/analysis package and regulator-ready application evidence
10.1 The eCTD structure10.2 The submission data package10.3 Conformance & agency expectations10.4 Communicating standards & data with agencies10.5 Putting it together — a submission dry run
11
Capstone 18–25 hours

CLIN-301 End-to-End Production Release

Run the whole clinical programming lifecycle as one controlled project

Deliver and defend a compact submission package from protocol extraction through datasets, analyses, TLFs, CSR handoff and reviewer response.

0/6 gates0%
Start first chapter
Starts with: CLIN-301 protocol/SAP excerpts, aCRF, raw EDC and vendor transfers
Hands off: Portfolio-ready capstone release with traceability demonstration and retrospective
11.1 The scenario11.2 CRF → SDTM11.3 SDTM → ADaM11.4 ADaM → TLFs, part 1: the standard set11.5 ADaM → TLFs, part 2: efficacy & safety11.6 Assemble the submission

Decisions before syntax

Each topic starts with the clinical or regulatory decision the code must implement.

Artifacts, not passive reading

Every chapter produces a specification, dataset, check, display, guide, or release artifact.

Quality gates at every handoff

Completion means the deliverable is traceable, reproducible and ready for its next consumer.

Curriculum baseline reviewed against CDISC foundational standards, ICH guidance and FDA study-data resources.