Full-length Clinical Study Protocol and Investigator's Brochure templates, with example text in every section. Download the file and compare it against any suite you already use. No sales call, no stripped excerpts.
Vertex Writing Solutions publishes free, full-length regulatory document templates: a Clinical Study Protocol template aligned to ICH M11, and an Investigator's Brochure template aligned to 21 CFR 312.55 and ICH E6(R3). Each ships with example text in every section. The files are de-identified and free, and no sales call is required.
Each template is a full Word document with section structure, production-grade formatting, and concrete example text in every major section. Example content is de-identified and illustrative. See the use terms below each card and the full Terms of Use and Disclaimer.
Full protocol template with example text across synopsis, design, eligibility, statistical analysis, and oversight sections. Numbering and cross-references hold across amendments.
Free download · Word (.docx) Download the template freeFull IB template, all sections, with example text, formatting, and Reference Safety Information structure ready to populate.
Free download · Word (.docx) Download the template freeThe templates are free, but they are not unrestricted. The notice below travels with every downloaded file. The full terms govern any use.
© 2026 Vertex Writing Solutions. All rights reserved. Provided free for evaluation and internal reference; not for resale, sublicensing, or redistribution. Full customizable suites are licensed separately.
These templates are provided for general illustration only. They are not regulatory, legal, or medical advice, and they are not a substitute for the judgment of a qualified regulatory or medical-writing professional. The example text is illustrative and de-identified. It does not represent any specific drug, sponsor, study, or submission, and any resemblance to a real product or trial is coincidental.
The templates are provided “as is,” without warranty of any kind, express or implied. Regulatory requirements and agency expectations change; Vertex makes no representation that a template is current, complete, or suitable for any particular submission. Use of a template does not guarantee acceptance by the U.S. FDA or any other health authority. You are responsible for verifying that any document you create meets the applicable regulatory, scientific, and legal requirements for your program. To the fullest extent permitted by law, Vertex Writing Solutions accepts no liability for any loss or damage arising from use of these templates.
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Yes. The Clinical Study Protocol and Investigator's Brochure templates are free to download and use for evaluation under the terms on this page. No payment and no sales call are required.
Yes. The Clinical Study Protocol template follows the ICH M11 structure, the Clinical electronic Structured Harmonised Protocol. Section order and headings map to M11, so a protocol built on it aligns with the current harmonized standard.
The IB template covers all sections required under 21 CFR 312.55 and ICH E6(R3), including the Reference Safety Information structure. Every section carries example text you edit rather than write from a blank page.
Yes. Each template is a Word document. You replace the example text with your own content and adapt the structure to your program. The template is a starting point; you are responsible for confirming the final document meets the requirements that apply to your submission.
TransCelerate, ICH M11, and CORE Reference provide a harmonized structure and model content to build from. Vertex adds full example text in every section and clean, built-in Word styles, so you start from drafted content with consistent formatting.
The free templates show the approach on two documents. The licensed Vertex suite extends across the regulatory authoring stack, including CSR, DSUR, and Module 2, and is tailored to your sponsor branding on delivery, with author tooling included.
The free templates show the approach. The licensed suite extends across the regulatory authoring stack, tailored to your sponsor styling on delivery.