Protocol qa

Skill thebitanpaul/VERA/.claude/skills/protocol-qa

Version-Explicit Retrieval & Answering - VERA answers a trial coordinator's question about what a clinical-trial protocol currently requires, using only the version that governs the trial today — and it abstains rather than guessing when the protocol doesn't cover the question.

Install

npx -y skills add thebitanpaul/VERA --skill protocol-qa

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What its author says it does

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Answer a clinical-trial coordinator's question about what a protocol CURRENTLY requires — eligibility, concomitant medications, dosing, washout periods, visit timing — for a specific trial. Answers come only from the current governing protocol version, always with citations (trial, version, section, effective date), and disclose when a rule changed across versions. Use whenever a coordinator asks whether something is permitted, what a requirement is, or what changed. If the protocol does not cover the question, VERA abstains rather than guessing.

SKILL.md

4.7 KB, as published. Nobody here has run it

Protocol Q&A (VERA)

This skill answers protocol questions by running the local VERA tool (python -m vera). You must not answer protocol questions from your own knowledge. Only relay what VERA returns. VERA reads the ingested protocol documents, resolves which version currently governs the trial, retrieves the relevant sections, and either answers with citations or abstains.

When to use

Use this skill when a coordinator asks anything like:

"Is <drug> permitted / allowed / excluded for trial <N>?"
"What is the washout period / dose limit / visit window?"
"What changed between protocol versions?"
Any question about what the protocol currently requires.

Do not hand-write a protocol answer, and do not use general medical knowledge — route every such question through VERA.

How to run it

Get the question and the trial number. If the coordinator did not say which trial, ask. (The demo dataset contains Trial 412.)
Run VERA from the project root with the Bash tool, always with --no-escalate on the first pass (this suppresses the tool's own prompt so you can handle escalation in the conversation instead):
```
python -m vera "<the coordinator's question, verbatim>" --trial <N> --no-escalate
```
Pass the question exactly as asked, in double quotes. Do not rephrase it.
Read VERA's output and relay it (see below). Keep every citation.

How to read and relay the result

VERA prints one of two things.

A. An answer

The output starts with the governing version, then a [backend: ...] line, then the answer, a Provenance: block, and a Verifier: PASSED line. For example:

Trial 412: governing version v3.0 (effective 2025-03-01) as of 2026-07-24
[backend: mock]
Per Trial 412 v3.0 §5.2 (Eligibility - Concomitant Metformin), effective 2025-03-01:
  Concomitant metformin is permitted ... does not exceed 2000 mg/day ...
Change disclosure — this differs from the earlier Trial 412 v1.0 §5.2 ...
Provenance:
  [current]    Trial 412 v3.0 §5.2 ...
Verifier: PASSED — ...

Relay it to the coordinator in plain language, and always keep:

the answer itself (e.g. "permitted, up to 2000 mg/day"),
the citation — trial, version, section, and effective date,
any change disclosure ("this changed from version 1.0, which excluded it").

Never drop the citation or the version — knowing which version the answer comes from is the whole point.

B. An abstention

If the output contains:

INSUFFICIENT EVIDENCE — escalating

Reason: <why>

then VERA could not answer safely. This happens when the topic is not in the current protocol version, retrieval confidence is too low, or the answer could not be grounded in a cited passage. Do not fill the gap with your own knowledge.

Tell the coordinator, in plain language, that the question can't be answered from the current protocol and give the reason. Then ask them:

"I can't answer this from the current protocol. Would you like me to escalate it to the protocol team so they can follow up?"

If yes, re-run the same command with --escalate instead of --no-escalate:
```
python -m vera "<same question>" --trial <N> --escalate
```
This files an Azure DevOps work item (via the ADO MCP server in production, or a JSON file under var/escalations/ in this demo) summarising the question, trial, and reason. Confirm to the coordinator that it was raised.
If no, do nothing further and confirm the question was left unanswered.

Always ask before escalating — this prevents a flood of low-value tickets.

Notes

Runs on a deterministic mock model by default (no setup needed). To use a real model, add a GEMINI_API_KEY (or ANTHROPIC_API_KEY) to a .env file; see .env.example. Backend selection does not change how you use this skill.
If the output contains a [warning] line about the backend, the live model was unavailable and the deterministic fallback answered instead. The answer is still grounded in the protocol — mention the degradation, don't hide it.
See README.md for example questions and expected results.