PHS Human Subjects and Clinical Trials Information Form Agent Skill

Complete the PHS Human Subjects and Clinical Trials Information form — study records, the clinical-trial questionnaire, eligibility…

Context cost
1.6k tokensestimated from the bundle, loaded when it triggers
Bundle
1 file · 6.4 kBtext throughout, nothing executable
Licence
not declarednone named by its author
Last change
—no release on file
Servers it uses
Noneruns standalone

What it does

Complete the PHS Human Subjects and Clinical Trials Information form — study records, the clinical-trial questionnaire, eligibility criteria, inclusion enrollment reports, recruitment and retention plans, the Protection of Human Subjects attachment, data and safety monitoring plans, sIRB plans, and the protocol synopsis for clinical trials. Use whenever the user mentions the human subjects form, a study record, enrollment targets or inclusion enrollment reports, recruitment plans, DSMP or DSMB, single IRB, protocol synopsis, or preparing the clinical trials sections of an NIH application.

What this skill changes about the agent has not been set out here as a list. Its SKILL.md, shown below, says it in the author’s own words.

productivity

The skill itself

A skill is instructions the model reads, so you can see what you are getting: below is the start of its SKILL.md. The front matter loads with every session, the body loads when the skill triggers, and the whole file comes with the install.

SKILL.md6.4 kB · preview
--- name: grant-human-subjects ---
6# PHS Human Subjects and Clinical Trials Information Form
7
8This form restates the Approach's design decisions in regulatory structure, which dictates its timing: run it **after** the study design and enrollment numbers are settled in the Approach — drafting it earlier produces rework and, worse, inconsistencies between the form and the research plan that reviewers and validation systems both catch. Much of the form is enforced at submission validation (a required field left blank stops the application), and the rest is rated by reviewers as protections and inclusion considerations, where "unacceptable" bars award until resolved.
9
10Read _agent/project-config.md, the final Approach (design, sample sizes, statistical plan), and the timeline. grant-compliance-sections owns the upstream determination (is this human-subjects research? a clinical trial?) and the cross-cutting compliance view; this skill owns the form itself. Files go to 07_compliance/, one file per study record, versioned. Verify field names and requirements against the current form version and application guide — the FORMS packages change periodically. Apply _agent/style-profile.md to every sentence of document text, and before delivering drafted or revised prose check it against the profile's *Directives* list item by item, counting any punctuation the profile constrains rather than estimating (shared convention 5).
11
12## Step 0 — Study inventory and classification
13
14One study record per study; get the boundaries right before drafting (two arms of one protocol are one study; two protocols are two records). For each study, walk the NIH four-question clinical-trial test with the user — human participants? prospectively assigned to an intervention? designed to evaluate the intervention's effect? a health-related biomedical or behavioral outcome? — all four yes means clinical trial, which activates Section 4, the DSMP requirement, clinical-trial-permitting FOA eligibility, and ClinicalTrials.gov registration obligations at award. Check exemption categories where claimed, and for human-subjects work that depends on earlier aims' results, propose a **delayed onset** justification instead of a speculative study record.
15
16## Step 1 — Population, eligibility, enrollment (Section 2)
17
18- **Conditions and eligibility criteria**: inclusion and exclusion criteria stated precisely enough to operationalize — these are read as a test of whether the team has actually planned the study.
19- **Age range and inclusion across the lifespan**: any exclusion of children or older adults needs scientific justification, not convenience.
20- **Inclusion of women and minorities + the Inclusion Enrollment Report**: the planned-enrollment table by sex/gender, race, and ethnicity. The totals must equal the Approach's n exactly, and the distribution should reflect the condition's epidemiology or the catchment population — a table that doesn't will draw an inclusion comment. Justify any single-sex design (coordinate with the SABV check in grant-compliance-sections).
21- **Recruitment and retention**: where participants come from, at what rate, and what retains them. Do the arithmetic explicitly: accrual rate × recruitment window ≥ target n, with the sources named (clinic volume, registry size). Implausible enrollment is one of the most common clinical-study critiques, and it is checkable — check it.
22- **Study timeline and first-enrollment date**: consistent with grant-timeline-milestones.
23
24## Step 2 — Protection and monitoring (Section 3)
This is a preview of SKILL.md. Download or install the skill to get the whole thing.
In the file
SKILL.md896 words
Files1
Licencenot declared
Why you can read it

Nothing in a skill executes. The client loads the text and the model follows it, so a skill can be audited the way a runbook is — by reading it.

What it costs in context

Skills are not billed by the call. They are paid for in context: every token the instructions occupy is a token your code, your diff and your conversation cannot use. Here is what this one takes and when it takes it.

≈160
always loaded
The name and description, so the model knows the skill exists and when to reach for it.
1,440
on trigger
The instruction body, read only when the skill fires.
0.80%
of a 200k window
Ten skills this size would take about 8% of the window before you open a file.
050k100k150k200k context window

1.6k tokens, estimated from the bundle at four bytes to the token, held for the rest of the session once it triggers. Middling. Fine to keep on in a project where you use it weekly, worth unloading in one where you never do.

Servers bill, skills cost

A server charges by the month. A skill charges once per session, in context, and then keeps charging it for as long as the session lives.

Before and after

The same question, put to the same model twice: once as it comes, and once with these instructions loaded.

No worked example has been published for this skill yet.

The procedure it runs

The procedure has not been set out here step by step. It is in the body of its SKILL.md: the start of it is shown above, and the whole file comes with the install.

Prose, not code

These steps are written for a model to follow, not executed by a runtime. It can still be told to skip one, and it will say so when it does.

Servers it uses

None. This skill calls no MCP servers at all.

Everything it needs is in the instructions, so it works in a project with nothing connected — the model reads the file and changes how it works with what it can already reach.

Its SKILL.md does not declare which tools it asks the agent for, so what it touches is whatever the instructions themselves ask for — read them before you install it.

What it asks for
Writes filesnot declared
Network accessnot declared

This SKILL.md carries no allowed-tools line, so neither is declared. A skill grants no permissions of its own — it can only ask for tools your client already has.

What it will not do

Every skill is narrow, and the useful ones say where they stop. These are the jobs this one is the wrong tool for.

What this skill is not for has not been published here. Nothing is implied by that: it is a section the author has not filled in.

What is in the bundle

1 file, 6.4 kB on disk. A bundle is text throughout: the instructions the model reads, plus the templates it fills in.

  • SKILL.md6.4 kB
What is not in it

No dependencies and nothing executable: a skill is text the agent reads, so the bundle is 1 file you can review in full before installing.

Install

Installing copies the bundle into your project. Nothing runs at install time — the files sit on disk until the model reads them.

# PHS Human Subjects and Clinical Trials Information Form · 1.6k tokens when loaded · macOS, Linux mkdir -p .claude/skills && t=$(mktemp -d) && curl -fsSL -o "$t/bundle.tar.gz" https://mcprush.com/api/skills/phs-human-subjects-and-clinical-trials-informatio/bundle.tar.gz && tar -xzf "$t/bundle.tar.gz" -C "$t" && [ -d "$t/phs-human-subjects-and-clinical-trials-informatio" ] && { [ ! -e .claude/skills/phs-human-subjects-and-clinical-trials-informatio ] || { mv .claude/skills/phs-human-subjects-and-clinical-trials-informatio "$t/.previous" && echo "Previous copy moved to $t/.previous"; }; } && mv "$t/phs-human-subjects-and-clinical-trials-informatio" .claude/skills/ && echo "Installed .claude/skills/phs-human-subjects-and-clinical-trials-informatio"
On Windows, or any OS with Node 20+
npx mcprush@latest skill add joshua-d-campbell/phs-human-subjects-and-clinical-trials-informatio

Windows PowerShell says 'running scripts is disabled on this system'? Run Set-ExecutionPolicy -Scope CurrentUser RemoteSigned once, or type npx.cmd instead of npx (codex.cmd, gemini.cmd, grok.cmd likewise). PowerShell 7 needs neither. Writes to .claude/skills/phs-human-subjects-and-clinical-trials-informatio/ in the current project. For every project instead, run mkdir -p ~/.claude/skills && t=$(mktemp -d) && curl -fsSL -o "$t/bundle.tar.gz" https://mcprush.com/api/skills/phs-human-subjects-and-clinical-trials-informatio/bundle.tar.gz && tar -xzf "$t/bundle.tar.gz" -C "$t" && [ -d "$t/phs-human-subjects-and-clinical-trials-informatio" ] && { [ ! -e ~/.claude/skills/phs-human-subjects-and-clinical-trials-informatio ] || { mv ~/.claude/skills/phs-human-subjects-and-clinical-trials-informatio "$t/.previous" && echo "Previous copy moved to $t/.previous"; }; } && mv "$t/phs-human-subjects-and-clinical-trials-informatio" ~/.claude/skills/ && echo "Installed ~/.claude/skills/phs-human-subjects-and-clinical-trials-informatio" (macOS, Linux) — or add --global to the npx line. The curl line replaces .claude/skills/phs-human-subjects-and-clinical-trials-informatio/ only after the download succeeds, so files left there by another skill of the same name, or by an older release, do not mix in. A copy already there is moved aside, not deleted, and the line prints where. It appears as grant-human-subjects in Gemini CLI, Codex, Copilot and Grok (its own name); Claude Code lists it by the folder name, phs-human-subjects-and-clinical-trials-informatio.

Which clients pick it up on their own

A skill is a folder of text. Most of these read a skills folder and pick it up without being told; the rest take the same folder another way — an upload in the app, a parameter on an API call — and then choose it by its description just the same.

Claude Code.claude/skills/
Claude DesktopCustomize › Skills
ChatGPTSkills › Create › Upload
Cursor.cursor/skills/
VS Code.github/skills/
Codex CLI.agents/skills/
Gemini CLI.gemini/skills/
Grok Build.grok/skills/
Microsoft CopilotSkills › Upload a skill
PerplexityComputer › Skills › Upload a skill
DeepSeek Harness.dsh/skills/
Zed.agents/skills/
Devin Desktop.devin/skills/
Windsurf (legacy).windsurf/skills/
OpenAI Agents SDKInstructions or sandbox Skills
HTTP / APIa request parameter
This release
Versionnot versioned
Publishedno release date on file
PriceFree
Referencejoshua-d-campbell/phs-human-subjects-and-clinical-trials-informatio

Versions

Its author publishes no version number, so there is nothing here to pin to: what you install is the folder as it stands today. Instructions change more often than APIs do — a skill can be rewritten entirely without anything it depends on moving.

Pinning

Nothing to pin to: this skill carries no version number of its own. What you install is what the folder holds on the day you install it.

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