GLP Toxicology Study Report

1. What this module does

You enter the groups with their doses and animal numbers, the findings by dose with the change versus control, any unscheduled deaths and the deviations.

The tool sets the NOAEL as the highest dose with no adverse finding at that or any lower dose, compares it with the NOAEL the study director proposes, and checks group sizes, dose selection, recovery and toxicokinetics, deviations and the GLP compliance and QA statements.

What you get

• A Word or PDF report: GLP toxicology study report (Module 4.2.3.2).

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• Groups, doses and animal numbers.
• Findings by dose with the change versus control.
• Deviations with their impact assessment.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/glp-toxicology-report.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the study

   Enter the study number, title, facility and study director, the species type and the dosing and recovery periods.

   

2. Enter groups and findings

   One row per group and per finding. Write "yes" in Adverse for each adverse finding.

3. Read the result

   The headline gives the NOAEL: "NOAEL 30 mg/kg/day · report complete".

   

4. Resolve alerts and download

   A missing GLP or QA statement and test item related deaths are critical. A proposed NOAEL that differs from the findings, body weight loss of 10% or more marked not adverse, and deviations without an impact assessment are flagged. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Study

2 · Groups

One row per group. Dose 0 is the control. Recovery and toxicokinetic (TK) animals per sex.

3 · Findings

One row per finding and dose group. Change versus control in % where it applies. Adverse: yes when the finding is adverse; Reversible: yes when it recovered.

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• NOAEL from the adverse findings.
• Group sizes, dose levels, high-dose justification, recovery and toxicokinetics.
• GLP and QA statements, deviations and archive.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Conclusion. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US: 21 CFR Part 58. EU: OECD Principles of GLP (Directive 2004/10/EC). The OECD test guidelines apply to both.

8. Working with other modules

• The study is summarised in the Nonclinical Overview & Summaries.

9. Common pitfalls

• A NOAEL set at a dose with an adverse finding.
• Deviations listed without an impact assessment.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Make a finding adverse

   Mark the liver weight increase at 30 mg/kg/day as adverse.

   Expected resultThe headline shows the proposed NOAEL differs from the findings.