Vertex's own free templates and writing guidance, followed by a curated read on the guidance and the conversation shaping how clinical documents get written: ICH M11, E6(R3), and the practical questions around AI in regulatory writing.
The practical material Vertex publishes: full-length free templates, best-practice articles tied to specific documents, and the primary guidance the templates are built against.
Full Clinical Study Protocol and Investigator's Brochure templates with example text built in, free to download for evaluation.
Go to downloadsBest-practice writing for the documents that move drugs, each article anchored to a specific template with before-and-after example text.
Read the articlesWhat separates an Investigator's Brochure that earns a clean IND from one that triggers an information request. Section by section, with example text.
Read the articleSelected for relevance to the documents Vertex templates support. Links go to the original source. Vertex curates these for relevance and does not endorse the views expressed; agency pages are the authoritative record for any requirement.
The ICH Assembly adopted M11, which establishes a harmonized protocol template known as the Clinical electronic Structured Harmonised Protocol (CeSHarP). It sets a standard protocol structure and an electronic data-exchange format.
Why it matters: M11 is the structured-protocol standard the Vertex protocol template aligns to.
Read at Regulatory FocusFDA's adoption of the revised ICH E6(R3) GCP guideline. It moves GCP toward quality-by-design and risk-based quality management and builds in flexibility for decentralized elements, digital tools, and real-world data.
Why it matters: it resets the expectations protocols and trial-conduct documents are written against.
Read at FDA.govA joint FDA-EMA set of ten principles for using AI across the drug-development life cycle, covering human-centric design, a risk-based approach, data governance, life-cycle management, and context of use.
Why it matters: a short, citable standard for defending how AI was used in document preparation.
Read at FDA.govFDA's CDER hub for AI in drug development, anchored by the January 2025 draft guidance that proposes a risk-based credibility assessment tied to a model's context of use. The page also tracks the CDER AI Council.
Why it matters: AI used to generate content or data supporting a submission falls under this framework.
Read at FDA.govA DIA 2026 interview on why structured protocols stayed out of reach (no standard data model, ambiguous clinical language, no tolerance for error) and what changed: capable language models, the USDM standard, and validated environments.
Why it matters: current trade coverage of the structured-protocol shift M11 formalizes.
Read at Applied Clinical TrialsAn AMWA membership survey on current knowledge, experience, and needs around generative AI in medical communication, meant to guide the association's AI Task Force. A profession-level read on how medical writers are actually adopting these tools. Full text is members-only; the abstract is public.
Why it matters: a workforce-level signal on AI adoption among the writers who are Vertex's end users.
Read at AMWA JournalA study of an AI platform drafting IND nonclinical written summaries (eCTD 2.6.2, 2.6.4, 2.6.6). First-draft time fell by roughly 97% with no critical regulatory errors found, but quality scored 70–78%; the authors conclude expert writers are still needed to reach submission quality. Preprint, not yet peer-reviewed.
Why it matters: quantified evidence on where AI helps and where human writers remain essential.
Read on arXivAn argument that CSR drafting time has barely moved over a decade because the bottleneck is the process, not the technology. It calls for data standardization, objective rather than interpretive content, and removing redundancy by referring to source tables instead of restating them.
Why it matters: a document-quality case that maps onto template design and CSR / Module 2.5 and 2.7 work.
Read at Applied Clinical TrialsExternal links open in a new tab and were verified at the time this page was prepared (June 2026). Sources can move or restrict access over time; if a link no longer resolves, the title and date above are enough to find it. See our Disclaimer on external links.
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