CSR Drafter’s Launchpad – Clinical Study Report Toolkit

CSR Drafter’s Launchpad

Product Description

The CSR Drafter’s Launchpad is a specialized toolkit designed for medical writers and clinical researchers preparing Clinical Study Reports (CSR) in compliance with ICH E3 guidelines. It provides a structured Notion-ready framework, practical drafting aids, and quality control tools to streamline the writing process and reduce time spent on formatting and organization.

What’s Inside

CSR Notion Framework (Markdown Template)

A copy-paste Notion-compatible structure aligned with ICH E3 CSR sections. Includes guidance notes, drafting spaces, QC checklists, and example tables.

Boilerplate Snippet Library (Markdown + PDF)

A curated set of ready-to-use text snippets for common CSR sections (e.g., Patient Disposition, Adverse Events, Efficacy Results). Delivered in both Markdown (for easy insertion into Notion) and PDF format.

Setup Guide (PDF)

Step-by-step instructions for importing and using the Markdown template within Notion.

Intended Users

Medical writers drafting regulatory-compliant CSRs.

Freelancers and early-career professionals seeking structured guidance.

Clinical researchers who need standardized reporting frameworks.

Format & Requirements

Files provided in Markdown (.md), PDF (.pdf) formats.

Import requires manual copy-paste into a Notion workspace (not a pre-linked Notion template).

License

For personal or internal team use only. Redistribution, resale, or sharing of files is prohibited.