AI can accelerate structured writing tasks. Clinical interpretation and regulatory judgement remain human responsibilities.
Purpose
This framework provides a practical model for deciding how much AI involvement is appropriate for a given task, and what review it requires. For an overview of why AI risk varies across medical writing tasks, common failure modes, and what makes a task higher risk, see Understanding AI Risk.The framework
Four tiers classify AI use by the impact of error and the degree of human judgement required.| Tier | Role of AI | Impact if wrong | Human involvement |
|---|---|---|---|
| 1. Assistive | Structure, search, organise | Low — correctable in standard review | Writer reviews and refines |
| 2. Structured transformation | Adapt, convert, reformat | Medium — meaning can drift without detection | Detailed review against source |
| 3. Evidence-critical | Extract, verify, draft from data | High — incorrect data propagates downstream | Expert verification of every value |
| 4. Human authority required | Supporting role only | Very high — regulatory, clinical, or compliance consequence | Human controls the process; AI assists |
How to read the tiers
AI use becomes higher risk as either:- the impact of being wrong increases (a transposed HR in a CSR vs. a formatting error in an outline)
- the task requires more interpretation (reporting a number vs. drawing a clinical conclusion from it)
Workflow mapping
Where each playbook workflow sits in the framework. Ranges indicate that the tier depends on how AI is used within the workflow.| Workflow | Tier | Notes |
|---|---|---|
| Find Evidence | 1 | AI supports search strategy; human selects sources |
| Summarise a Paper | 1 | AI structures; human verifies data points |
| Congress Summary | 1–2 | Extraction is Tier 1; contextualisation is Tier 2 |
| Extract Study Data | 3 | Every extracted value must be verified against source |
| Extract Key Messages | 3 | Message framing and evidence strength require expert judgement |
| Build an Outline | 1 | Structural task; low consequence if refined |
| Write a Manuscript | 2–3 | Methods/Results drafting is Tier 2; Discussion interpretation is Tier 3–4 |
| Draft a Regulatory Document | 4 | Regulatory wording and interpretation require human authority |
| Convert Stats to Narrative | 2–3 | Mechanical conversion is Tier 2; verifying accuracy is Tier 3 |
| Create a Slide Deck | 2 | Content reformatting with meaning-drift risk |
| Adapt for Audiences | 2 | Simplification can change meaning without visible errors |
| Plain Language Summary | 2 | Patient-facing; oversimplification risk |
| Verify Claims | 3 | Verification accuracy has direct downstream impact |
| Compliance Check | 4 | Compliance judgement cannot be delegated to AI |
| Check Document Consistency | 2 | AI flags candidates; human confirms true inconsistencies |
| Repurpose Content | 1–2 | Reformatting is Tier 1; channel-specific adaptation is Tier 2 |
| Final Review | 4 | The sign-off is a human responsibility |
Review expectations by tier
What human review should look like at each level.Tier 1 — Assistive
- Confirm relevance and completeness
- Verify key data points against sources
- Check that structure matches the deliverable purpose
- Standard medical writing review is sufficient
Tier 2 — Structured transformation
- Detailed comparison between source and output
- Check for meaning drift, dropped qualifiers, and shifted emphasis
- Verify that safety information is preserved proportionately
- Cross-check every clinical claim against the original
Tier 3 — Evidence-critical
- Expert verification of every numerical value against source data
- Confirm analysis populations, endpoint definitions, and statistical measures are correctly attributed
- Verify that no AI-generated interpretation has entered the output
- Spot-check unflagged content as well as flagged items
Tier 4 — Human authority required
- Human controls the process from the start; AI assists with specific tasks (formatting, structuring, locating information)
- Expert review of all wording, interpretation, and conclusions
- No AI output enters the final deliverable without explicit human approval
- Formal sign-off by a qualified professional
Where AI should not be the deciding layer
Regardless of tier, AI should not serve as the final authority for:- Clinical interpretation — whether a result is clinically meaningful
- Regulatory conclusions — whether a document meets applicable guidance
- Benefit-risk assessment — weighing efficacy against safety for a specific population
- Compliance sign-off — whether content meets the requirements of a promotional code
- Final approval — the decision that a deliverable is ready for submission, publication, or external use
Using this framework in practice
For individual writers: Before starting an AI-assisted task, identify which tier it falls into. Match your review effort to the tier. If you are unsure, default to the higher tier. For team leads: Use the tiers to set expectations for AI-assisted work across your team. Define which tiers require senior review, which require source cross-checks, and which require formal sign-off. For client or stakeholder conversations: The framework provides a clear, defensible answer to “how do you ensure AI-assisted content is accurate?” You can point to the tier, the review process, and the accountability structure. When a task spans multiple tiers: Many real-world deliverables involve tasks at different tiers. A manuscript has Tier 1 outlining, Tier 2 Methods drafting, and Tier 3–4 Discussion interpretation. Apply the appropriate review to each component, not a single blanket review to the whole document.Related principles
- Human-in-the-Loop Decision Making — every deliverable has a named owner
- Source Grounding — every claim traces to a cited source
- Understanding AI Risk — why risk varies across tasks, failure modes, and risk factors
- Review and Accountability — sign-off protocols and audit trails
Related workflows
- Verify Claims Against References — Tier 3 verification in practice
- Draft a Regulatory Document — Tier 4 drafting with human authority
- Convert Stats to Narrative — Tier 2–3 mechanical translation
- Final Human Review — the Tier 4 sign-off process