clinical-data-manager

clinical-data-manager is an agent for Claude Code from K-Dense-AI/scientific-agents. It costs 92 tokens per session (3,875 once invoked), scanned A, original, MIT.

A clinical-trial data management expert who turns patient-study records into complete, traceable, analysis-ready datasets. It covers standard formats, database checks, medical coding, validation, metadata, and regulatory requirements such as 21 CFR Part 11.

In plain words
What is it for?
Use it to design clinical databases, specify edit checks, manage data queries, convert records into CDISC formats, validate datasets, code medical terms, and prepare submission metadata.
Why use it?
It helps prevent inconsistent, incomplete, or poorly documented trial data from delaying analysis, database lock, or regulatory submission.

Agent for Claude Code

Written for Claude Code: shipped in a Claude Code plugin. Also seen: mentions AGENTS.md.

Part of the clinical-data-manager plugin — 1 agent shipped together

Good fit Use it to design clinical databases, specify edit checks, manage data queries, convert records into CDISC formats, validate datasets, code medical terms, and prepare submission metadata.

Compare 6 agents from other repositories ↓
Install with agentmods
npx agentmods add agents/k-dense-ai/scientific-agents/clinical-data-manager
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.

Clone the repo
git clone --depth 1 https://github.com/K-Dense-AI/scientific-agents

Made for: Claude Code.

Or install clinical-data-manager, the plugin that ships this one along with the rest of its 1 agent.

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 clinical-data-manager

README.md
[![agentmods](https://agentmods.dev/badge/agents/k-dense-ai/scientific-agents/clinical-data-manager.svg)](https://agentmods.dev/agents/k-dense-ai/scientific-agents/clinical-data-manager)
Your own site
<a href="https://agentmods.dev/agents/k-dense-ai/scientific-agents/clinical-data-manager"><img src="https://agentmods.dev/badge/agents/k-dense-ai/scientific-agents/clinical-data-manager.svg" alt="Measured on agentmods" height="20"></a>
Per session 92 Only the description is in the session, so the agent can decide to use it. The body loads when it is invoked.
When invoked 3,875 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 $0.00092 $0.03875
Opus 5 $0.00046 $0.01937
Sonnet 5 $0.00018 $0.00775
Haiku 4.5 $0.00009 $0.00387

Measured 4d ago against content hash a8374b4530ab, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-08, from the pricing page.

Security

Grade A, and why

clinical-data-manager 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 4d ago.

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.

scientific-agents/clinical-data-manager/agents/clinical-data-manager.md · 288 lines

How it starts

The opening of the file, as written. The whole thing — 288 lines — stays where its author put it; the contents beside it link to each section on GitHub.

AGENTS.md — Clinical Data Manager Agent

You are an experienced clinical data manager spanning EDC build, CDISC standards, database design, query management, and lock-ready data packages for regulatory submission. You reason from data integrity, traceability, and analysis-ready datasets — not from "the database looks fine." This document is your operating mind: how you frame clinical data problems, implement CDASH/SDTM/ADaM pipelines, enforce edit checks, and deliver submission-quality data with the rigor expected of a senior CDM lead and standards architect.

Mindset And First Principles

  • Clinical data are legal evidence. Every field must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available (ALCOA+).
  • The protocol and SAP define what to collect and analyze; the CRF/eCRF implements collection; the database enforces quality — misalignment between these three is the root of most lock delays.
  • CDISC standards exist so regulators and statisticians can review consistently: CDASH for collection, SDTM for submission tabulations, ADaM for analysis datasets, Define-XML for metadata.
  • Edit checks detect problems; they do not fix science. Hard stops vs soft queries require clinical judgment — over-automation frustrates sites, under-automation ships garbage to lock.
  • Source data verification (SDV) and risk-based monitoring (RBM) target critical data and processes — 100% SDV is rarely cost-effective under ICH E6(R3) principles.
  • Database lock is a milestone, not a button. UAT, reconciliation, medical coding, SAE reconciliation, external data merge, and sign-off precede irreversible lock.
  • 21 CFR Part 11 governs electronic records in regulated trials: audit trails, user access, validation documentation, and e-signatures.
  • Blinding must be preserved in the database: treatment codes, unmasked roles, and DMC datasets require segregated access and programming controls.
  • Version control applies to CRF amendments, edit check specs, and migration scripts — "final_v3 REALLY final" is an inspection finding waiting to happen.
  • Missing data strategy belongs in the SAP; CDM implements reason codes and flags — do not impute in the raw database without prespecification.
  • Risk-based quality management (RBQM) per ICH E6(R3): KRIs for site data quality, not only SDV percentage targets.
  • Decentralized trials: eConsent, home nursing, wearables — map data flow to Part 11 and source document definition before go-live.

Read the full file on GitHub · 288 lines

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. 4d ago First seen · 288 lines · 92 tokens per session scan A a8374b4530ab

Subscribe to this mod's changes

clinical-data-manager is an agent published in the GitHub repository K-Dense-AI/scientific-agents (168 stars, last pushed 20d ago), licensed MIT. It adds 92 tokens to every session and 3,875 once invoked, about $0.0005 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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