Documentation Index
Fetch the complete documentation index at: https://playbook.pharmatools.ai/llms.txt
Use this file to discover all available pages before exploring further.
Core principle
When AI is used in the production of a deliverable, that use must be declared — accurately, specifically, and in the right place. “We used ChatGPT a bit” is not a disclosure. Vague language fails under audit. The reviewer who signs off remains accountable; declaration does not transfer responsibility.Why this matters now
Through 2024–2025, the major medical journals, scientific societies, and regulators all moved to require explicit disclosure of AI use in submitted work. The trend is clear: non-disclosure is now the higher-risk position. A retraction triggered by undisclosed AI use damages the writer, the author group, the sponsor, and (for agency work) the client relationship. For pharma and medical-affairs teams, AI disclosure expectations now sit alongside the older expectations around financial disclosures, ghostwriting, and editorial assistance. The same principle applies: be specific, declare early, document as you go.The major policies (mid-2026 snapshot)
| Body | Position | What to disclose |
|---|---|---|
| ICMJE | AI cannot be listed as an author. Authors must disclose AI use in methods or acknowledgments. Authors retain full responsibility for all content. | Tool name, what it was used for, who reviewed |
| NEJM | Restrictive on substantive content generation. Editing/proofing typically permitted with disclosure. | Tool, scope of use, in methods |
| The Lancet | Permits AI assistance; requires disclosure of how AI was used and confirmation that authors take responsibility. | Tool, scope of use, in methods or acknowledgments |
| JAMA Network | Requires explicit disclosure of AI tools used, including version. | Tool name, version, scope, in methods |
| BMJ | Disclosure required for AI use beyond basic editing. | Tool, scope of use |
| Nature | Permits AI for editing/proofing without disclosure; disclosure required for content generation. | Tool, scope of use |
| Science / AAAS | Disclosure required for non-trivial AI use. | Tool, scope of use |
| WAME | Cross-publication guidance: AI is not an author; disclosure required; authors responsible. | Refer to specific journal policy |
What counts as “AI use”
Disclosure expectations vary by what AI was actually doing. The spectrum, from low to high disclosure risk:| Use | Typical disclosure expectation |
|---|---|
| Spell-check, grammar correction (Grammarly-style) | Often not required, but increasingly noted |
| Translation between languages | Required by most policies |
| Editing existing human-written prose for clarity or tone | Required by most policies |
| Ideation, brainstorming structure or angles | Often required |
| Drafting sections of prose | Required by all major policies |
| Generating tables, figures, or data summaries | Required, often with stronger restrictions |
| Generating citations or reference lists | Required and high-risk; verification mandatory |
| Image generation (concept visuals, illustrations) | Required, often with explicit constraints (e.g., not for scientific data figures) |
| Statistical analysis or data extraction | Treated as analytical contribution; full methods disclosure |
What to declare, where, and how
What to include
- The specific tool used (name and version, where versioning is meaningful)
- What the tool was used for (drafting, editing, translation, etc.)
- The scope (which sections, which deliverables)
- How the output was reviewed and by whom
Where to put it
- Manuscripts: Methods section is the standard location for substantive use; acknowledgments for editorial assistance.
- Conference abstracts and posters: Acknowledgments or footer.
- Regulatory documents: Per the relevant agency guidance, which is rapidly evolving.
- Promotional materials: Per the applicable code (ABPI, IFPMA) and client SOP.
Wording
Specific is better than vague. Compare:“AI was used during writing.”
“Claude (Anthropic, Opus 4.7) was used to draft the Discussion section. Output was reviewed and edited by [Author X], who is responsible for the final content.”The second version makes the reviewer accountable, names the tool, scopes the use, and could survive an audit. For ready-to-adapt wording across the common scenarios — manuscripts, posters, regulatory documents, promotional materials — see the Disclosure Language Template.
Common mistakes
Listing AI as a co-author
Listing AI as a co-author
Vague disclosures
Vague disclosures
“AI tools were used” or “We used ChatGPT” without specifying scope leaves the reader (and any post-publication investigator) unable to assess what was actually AI-generated. Be specific.
Reconstructing AI use after the fact
Reconstructing AI use after the fact
Trying to remember which sections used AI three months later is unreliable. Track AI use as you write: keep a brief log per section or per deliverable. The review and accountability audit-trail recommendations apply directly here.
Assuming AI for editing is exempt
Assuming AI for editing is exempt
Several journals (BMJ, Nature, ICMJE-aligned) treat substantive editing — even on human-written drafts — as disclosable. The threshold isn’t “AI wrote a paragraph”; it’s “AI changed the meaning, structure, or strength of a claim.”
Missing client or sponsor disclosure expectations
Missing client or sponsor disclosure expectations
Sponsor SOPs increasingly include AI use as a disclosable category in the same bucket as third-party editorial assistance. Check the client’s SOP before any AI-assisted work begins, not at the disclosure stage.
Beyond journals
- Conferences and societies (ISMPP, AMWA, EMWA): Increasingly request AI disclosure on submitted abstracts, posters, and oral presentations. Disclosure conventions are converging on the journal model.
- Regulators: FDA, EMA, MHRA, and PMDA have all issued guidance or reflection papers on AI use in regulated submissions through 2024–2025. Expectations are evolving fast; treat your client’s regulatory affairs team as the source of truth for any submission-bound deliverable.
- Pharma sponsors and clients: Many global pharma companies now require AI use to be declared in project briefs and final delivery documentation, regardless of journal or regulator requirements. The disclosure is internal, but the standard is the same: specific, contemporaneous, auditable.
How this connects to other playbook principles
- Human-in-the-loop: Disclosure does not reduce author responsibility. It documents the production process; the named human is still accountable.
- Review and accountability: The audit trail you maintain to support accountability is the same record you draw from for accurate disclosure. Build the habit once.
- Source grounding: Declaring AI use does not exempt AI-generated claims from full source verification. Both apply.
The bottom line
If you cannot specify what AI did, when, and who reviewed it, you do not have a disclosure — you have a defence. The standard now, across journals, regulators, and SOP-driven clients, is contemporaneous documentation. Build the habit during writing, not at submission.Last reviewed: 4 May 2026 · 6 min read