> ## 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.

# AI Audit-Trail Log Template

> Contemporaneous log of AI use across a project — supports disclosure, sponsor audits, and EU AI Act documentation.

A contemporaneous log of AI use across a project. The same record feeds journal disclosure, sponsor audits, and EU AI Act documentation. Build it as you write — reconstruction at submission time is unreliable.

For the principles behind this template, see [Review and Accountability](/principles/review-and-accountability) and [Declaring AI Use](/principles/declaring-ai-use).

## How to use this template

* **Start the log at project kickoff,** not at submission. "What tool did I use in week 2?" three months later doesn't survive audit.
* **One log per project, deliverable group, or workstream** — whatever your client or sponsor SOP defines as a unit.
* **Log every non-trivial AI use.** Spell-check is generally exempt; everything else benefits from capture.
* **Store the log in the shared project location,** not in a personal note. Audit trails that aren't shared aren't auditable.
* **Retain per the longest applicable timeframe** (sponsor SOP, journal author guidelines, regulatory archiving). Default is the project's record-retention period.

***

## Project header

Fill in once at kickoff. Update if scope or ownership changes.

| Field                      | Value                                                                          |
| -------------------------- | ------------------------------------------------------------------------------ |
| **Project name**           | \[e.g., Drug X Phase 3 primary publication]                                    |
| **Deliverable type**       | \[e.g., Primary publication / regulatory submission / promotional leave-piece] |
| **Sponsor / client**       | \[Sponsor or client name]                                                      |
| **Agency (if applicable)** | \[Agency name]                                                                 |
| **SOP reference**          | \[e.g., ABC-SOP-0042 v3.1]                                                     |
| **Project lead / owner**   | \[Name and role]                                                               |
| **Accountable reviewer**   | \[Name and role — the named human responsible for sign-off]                    |
| **Log start date**         | \[YYYY-MM-DD]                                                                  |
| **Log location**           | \[Folder path or project file where this log is stored]                        |

***

## AI use entries

One row per discrete AI use. Add rows as you go.

| Date       | Deliverable / section         | Tool + version          | Scope of use                       | Source inputs                                 | Reviewer | Outcome                            | Notes                                                             |
| ---------- | ----------------------------- | ----------------------- | ---------------------------------- | --------------------------------------------- | -------- | ---------------------------------- | ----------------------------------------------------------------- |
| 2026-05-04 | Manuscript Discussion section | Claude Opus 4.7         | Drafting (initial)                 | Trial CSR sections 11–14; key messages doc v2 | A. Smith | Accepted with edits                | Two paragraphs rewritten to add HR confidence intervals           |
| 2026-05-05 | Manuscript Methods section    | Claude Sonnet 4.6       | Editing for clarity                | Existing draft section                        | A. Smith | Accepted as-is                     | Light copy-edits only                                             |
| 2026-05-05 | All references (40)           | RefCheckr (closed-loop) | Reference verification and rewrite | Source PDFs of all cited references           | A. Smith | 3 rewrites accepted, 1 manual edit | Closed-loop output reviewed; one claim required manual rephrasing |
| 2026-05-08 | Visual abstract               | Nano Banana 2           | Concept image generation           | Brief prompt + key messages                   | M. Jones | Accepted                           | Caption updated to flag conceptual nature                         |
|            |                               |                         |                                    |                                               |          |                                    |                                                                   |
|            |                               |                         |                                    |                                               |          |                                    |                                                                   |
|            |                               |                         |                                    |                                               |          |                                    |                                                                   |

Add rows as needed. Keep entries one-line where possible; expand in the Notes column.

### Field guidance

* **Date** — when the AI was used, not when the entry was written.
* **Deliverable / section** — be specific enough that a reviewer can locate the work product. "Manuscript" alone is not specific; "Manuscript Discussion section" is.
* **Tool + version** — always include both. "Claude" without a version is undefined when reviewed six months later.
* **Scope of use** — one of: Drafting, Editing, Translation, Verification, Synthesis, Image generation, Other. Match the categories used in [Declaring AI Use](/principles/declaring-ai-use).
* **Source inputs** — what was given to the AI? Source documents, prompts, prior drafts.
* **Reviewer** — the named human who checked the AI output. A blank reviewer field means an unaccountable AI use; the row is not yet complete.
* **Outcome** — Accepted as-is / Accepted with edits / Rejected / Pending review. Clear all pending entries before sign-off.
* **Notes** — brief context: what changed, what didn't, what was flagged.

***

## Sign-off block

Complete at deliverable finalisation.

| Field                           | Value                                                                                                                  |
| ------------------------------- | ---------------------------------------------------------------------------------------------------------------------- |
| **Final deliverable version**   | \[Version number / file name]                                                                                          |
| **All log entries reviewed**    | \[Yes / No]                                                                                                            |
| **All pending entries cleared** | \[Yes / No]                                                                                                            |
| **Disclosure language drafted** | \[Yes / No — link to specific snippet from the [Disclosure Language Template](/templates/disclosure-language) if used] |
| **Final reviewer name**         | \[Name and role]                                                                                                       |
| **Sign-off date**               | \[YYYY-MM-DD]                                                                                                          |

***

## What this log supports

A single log feeds four downstream uses:

* **Journal disclosure** — entries become the basis for the AI-use statement, with the [Disclosure Language Template](/templates/disclosure-language) as the wording reference.
* **Sponsor or client audit** — when asked "What AI was used on this deliverable?", the log is the answer. Without it, you reconstruct from memory under pressure.
* **EU AI Act documentation** — the contemporaneous record of tool use, scope, and reviewer aligns with Article 50 transparency obligations and the general documentation expectations covered in [AI Regulation in Pharma](/principles/ai-regulation).
* **Internal QC retrospectives** — patterns emerge across projects: which tools cause the most rework, which scope of use produces the cleanest output, where reviewers spend their time.

***

## Common mistakes

* **Building the log at submission.** "I'll remember" is not a strategy. Weeks of AI use cannot be reconstructed reliably; entries get missed and the disclosure is weaker than it should be.
* **Logging only successful uses.** Rejected and revised entries matter — they show review was active, not rubber-stamped.
* **Vague tool names.** "ChatGPT" doesn't tell a reviewer in 18 months whether it was GPT-4 or GPT-5. Always include version.
* **Missing the reviewer column.** A log entry without a reviewer name is an unaccountable AI use. Complete the row before treating the entry as logged.
* **Storing the log in a personal note.** If a colleague needs the log during your absence and can't find it, the audit trail isn't auditable. Store in the shared project location.

***

## Related

* [Review and Accountability](/principles/review-and-accountability) — the principle this log operationalises
* [Declaring AI Use](/principles/declaring-ai-use) — the disclosure principle the log feeds
* [Disclosure Language Template](/templates/disclosure-language) — ready-to-paste wording derived from the log
* [AI Regulation in Pharma](/principles/ai-regulation) — the regulatory expectations this log helps meet

***

*Last reviewed: 4 May 2026 · 6 min read*
