bio-clinical-biostatistics-cdisc-data

bio-clinical-biostatistics-cdisc-data is a skill for Claude Code, Codex from GPTomics/bioSkills. It costs 136 tokens per session (7,882 once invoked), scanned A, original, MIT.

A guide for working with CDISC clinical-trial datasets: SDTM stores standardised study data, while ADaM prepares it for statistical analysis. It also covers metadata and traceability, which show where analysis values came from.

In plain words
What is it for?
Use it to read and join SDTM domains, build ADaM datasets, derive baselines and treatment-emergent adverse events, and handle Define-XML metadata.
Why use it?
It helps turn clinical-trial files into validated, analysis-ready datasets while preserving the links needed for review and regulatory work.

Skill for Claude CodeCodex

Written for no agent in particular: nothing here depends on one.

Good fit Use it to read and join SDTM domains, build ADaM datasets, derive baselines and treatment-emergent adverse events, and handle Define-XML metadata.

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Install with agentmods
npx agentmods add skills/gptomics/bioskills/cdisc-data-handling
Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add GPTomics/bioSkills --skill cdisc-data-handling
Clone the repo
git clone --depth 1 https://github.com/GPTomics/bioSkills

Made for: Claude Code, Codex.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for bio-clinical-biostatistics-cdisc-data

README.md
[![agentmods](https://agentmods.dev/badge/skills/gptomics/bioskills/cdisc-data-handling/github.svg)](https://agentmods.dev/skills/gptomics/bioskills/cdisc-data-handling)
Your own site
<a href="https://agentmods.dev/skills/gptomics/bioskills/cdisc-data-handling"><img src="https://agentmods.dev/badge/skills/gptomics/bioskills/cdisc-data-handling/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for bio-clinical-biostatistics-cdisc-data

Your own site · 80×15
<a href="https://agentmods.dev/skills/gptomics/bioskills/cdisc-data-handling"><img src="https://agentmods.dev/badge/skills/gptomics/bioskills/cdisc-data-handling.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 136 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 7,882 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00136 $0.07882
Opus 5 $0.00068 $0.03941
Sonnet 5 $0.00027 $0.01576
Haiku 4.5 $0.00014 $0.00788

Measured 6d ago against content hash 9f7edb32a333, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-09, from the pricing page.

Security

Grade A, and why

bio-clinical-biostatistics-cdisc-data scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 6d ago.

The scan reads SKILL.md. This mod also ships 1 executable file (examples/cdisc_data_preparation.py), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

Origin

Copies of this mod

1 near-identical copy found in the catalogue:

clinical-biostatistics/cdisc-data-handling/SKILL.md · 484 lines

How it starts

The opening of the file, as written. The whole thing — 484 lines — stays where its author put it; the contents beside it link to each section on GitHub.

Version Compatibility

Reference examples tested with: pyreadstat 1.2+, pandas 2.1+, numpy 1.26+. CDISC standards referenced: SDTM 2.0 / SDTMIG 3.4 (SDTM 3.0 / SDTMIG 4.0 in public review through April 2026); ADaMIG v1.3 (2021); OCCDS v1.1 (Nov 2021); BDS-for-TTE v1.0; Define-XML 2.1 (FDA-recommended for studies starting on/after March 15, 2023); Dataset-JSON v1.1 (Dec 2024; FDA Federal Register notice April 2025); Pinnacle 21 Community 4.0+; CORE (CDISC Open Rules Engine, 2021). Define-XML 2.1 FDA support began March 15, 2021 and is required for studies starting on/after March 15, 2023.

Before using code patterns, verify installed versions match. If versions differ:

  • Python: pip show <package> then help(module.function) to check signatures
  • R packages cited (essential for ADaM derivation): admiral (Roche/openpharma), metacore, metatools, xportr

If code throws ImportError, AttributeError, or TypeError, introspect the installed package and adapt the example to match the actual API rather than retrying.

CDISC SDTM and ADaM Data Handling

"Load clinical trial data" -> Parse CDISC SDTM domain files; build or consume ADaM analysis-ready datasets; preserve subject-level and event-level structure; respect traceability and validation expectations for regulatory submission.

  • Python: pyreadstat.read_xport(), pd.read_sas(), pd.merge()
  • R: haven::read_xpt(), admiral for ADaM derivation, Pinnacle21 or CORE for validation

Aggregation Strategy Taxonomy -- Choose the Right Question

Strategy Scientific question answered Example endpoint Fails when
Any event (binary) Does treatment change probability of experiencing the event at all? Had any serious AE: Yes/No Treatment changes event burden but not anyone-event probability
Event count Does treatment change burden of events per patient? Total AE count per subject Subjects with 1 vs 10 events treated equivalently
Maximum severity Does treatment shift patients toward more severe manifestations? Worst AESEV per subject Confounded with event count (more events -> higher chance of severe)
First event + time Does treatment delay onset of the event? Time to first serious AE (TTE) Multiple events per subject ignored
Rate (events per person-time) What is the per-time-unit rate? AEs per subject-year Requires exposure-time tracking; differential dropout biases rates
Composite (per ICH E9 R1) Event becomes part of endpoint definition Death = treatment failure Direction of components conflict; needs hierarchy

Read the full file on GitHub · 484 lines

Files

What ships with it

2 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 6d ago First seen · 484 lines · 136 tokens per session scan A 9f7edb32a333

Subscribe to this mod's changes

bio-clinical-biostatistics-cdisc-data is a skill published in the GitHub repository GPTomics/bioSkills (1,199 stars, last pushed 25d ago), licensed MIT. It adds 136 tokens to every session and 7,882 once invoked, about $0.0007 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-03.

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