Clinical Study Report

1. What this module does

You give the study, the primary endpoint with its alpha and p-value, the disposition and efficacy results by arm, the important deviations, the adverse events by arm, the number of narratives and the status of each E3 section.

The tool checks randomised = completed + discontinued in each arm, calculates the difference from control with a 95% confidence interval, compares the conclusion with the alpha, checks there is a narrative for each death, serious adverse event and discontinuation for an adverse event, and tracks the E3 sections.

What you get

• A Word or PDF file: clinical study report synopsis (Module 5.3.5.1).

2. Before you start

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

• Disposition and primary endpoint results by arm.
• Adverse event summary by arm.
• The statistical analysis plan (alpha, multiplicity).

3. Step by step with the example

Open the tool at app.cmcfy.com/app/clinical-study-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

   Give the study number, phase, title, primary endpoint, alpha, p-value and the conclusion.

   

2. Enter disposition, efficacy and safety

   One row per arm. Name the control arm "Placebo", "Control" or the comparator so the tool compares against it.

3. Read the result

   The headline gives the outcome: "Primary endpoint met · CMX-205 100 mg 46.7 points vs placebo".

   

4. Resolve alerts and download

   A disposition that does not add up, a "met" conclusion with p above alpha and a missing GCP statement are critical. Missing narratives and E3 sections 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 · Disposition and efficacy

One row per arm. For a responder endpoint give the number of responders; for a mean change give the mean and SD.

3 · Safety

One row per arm, numbers of subjects.

4 · ICH E3 sections

5. Checks and alerts

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

• Disposition in every arm.
• Primary result, confidence interval and conclusion.
• Narratives, deviations and E3 sections.

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: Synopsis conclusions. 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

ICH E3 applies in the US and the EU. The EU also needs a lay summary and a results summary in CTIS (Regulation (EU) 536/2014).

8. Working with other modules

• Plan the trial in the Clinical Trial Protocol; the CSR goes in Module 5 of the NDA & BLA Submission.

9. Common pitfalls

• Claiming a met endpoint on a p-value above alpha.
• Fewer narratives than serious adverse events.

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. Check the conclusion

   Change the p-value to 0.08.

   Expected resultThe headline shows a critical issue: the conclusion says met but p is not below alpha.