What is ksb-d07-k0033?

A learning guide for interpreting regulatory guidance and earlier regulatory decisions in drug-safety reporting. It covers frameworks and guidance from organisations such as the FDA and EMA.

Use it to study regulatory guidance, compare interpretations, plan implementations, and connect requirements to spontaneous-reporting systems.

It helps learners apply specialised reporting rules consistently instead of relying on informal interpretations.

ksb-d07-k0033 — Skill for Claude Code and Codex by ThomasMoreAI

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 ThomasMoreAI/legal-skills-open --skill ksb-d07-k0033

Clone the repo

git clone --depth 1 https://github.com/ThomasMoreAI/legal-skills-open

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.

README.md

[![agentmods](https://agentmods.dev/badge/skills/thomasmoreai/legal-skills-open/ksb-d07-k0033/github.svg)](https://agentmods.dev/skills/thomasmoreai/legal-skills-open/ksb-d07-k0033)

Your own site

<a href="https://agentmods.dev/skills/thomasmoreai/legal-skills-open/ksb-d07-k0033"><img src="https://agentmods.dev/badge/skills/thomasmoreai/legal-skills-open/ksb-d07-k0033/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.

Your own site · 80×15

<a href="https://agentmods.dev/skills/thomasmoreai/legal-skills-open/ksb-d07-k0033"><img src="https://agentmods.dev/badge/skills/thomasmoreai/legal-skills-open/ksb-d07-k0033.svg" alt="Reviewed on agentmods" width="80" height="20"></a>

Per session 25 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.

When invoked 495 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.

Model	Per session	Once invoked
Fable 5.1	$0.00025	$0.00495
Opus 5.5	$0.00010	$0.00198
Sonnet 5.5	$0.00005	$0.00099
Haiku 4.5	$0.00003	$0.00049

Measured 1mo ago against content hash a1a7eba2f8d9, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

ksb-d07-k0033 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 1mo 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.

cross-jurisdiction/life-sciences/skills/ksb-d07-k0033/SKILL.md · 67 lines

What it actually says

KSB-D07-K0033: Policy Interpretation

Overview

Domain: D07 - Spontaneous Reporting Systems Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Guidance document analysis, regulatory precedent evaluation, interpretation consistency, implementation planning

Context

Major Section: Global Spontaneous Reporting System Architecture
Section: Global Regulatory Framework Navigation

EPA Mapping

EPA-02:3004-3005
EPA-04:3009-3010
EPA-05:3011-3012

CPA Pathway

CPA-02, CPA-05

Regulatory References

FDA-CFR-002
ICH-E2C(R2)
ICH-E2F
EMA-GVP-004

Instructions

When this skill is activated, Claude should:

Demonstrate L1 proficiency in policy interpretation
Apply understand level cognitive skills to explain the topic
Reference relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

Guidance document analysis, regulatory precedent evaluation, interpretation consistency, implementation planning

Assessment Criteria

Can explain core concepts independently
Demonstrates understanding of regulatory context
Applies knowledge appropriately to PV scenarios

Other D07 skills in Global Regulatory Framework Navigation
Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31

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.

1mo ago First seen · 67 lines · 25 tokens per session scan A a1a7eba2f8d9

Subscribe to this mod's changes

ksb-d07-k0033 is a skill published in the GitHub repository ThomasMoreAI/legal-skills-open (95 stars, last pushed 15d ago), licensed Apache-2.0. It adds 25 tokens to every session and 495 once invoked, about $0.0001 per session on Opus 5.5. 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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