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Readability determines whether your document works—or fails—in practice. A protocol, briefing book,
or other regulatory submission document may be perfectly accurate, but if readers struggle to navigate the document, they most likely waste time, may make mistakes, and likely lose confidence in the work. Working definition: readability is the degree to which a document enables the intended readers to quickly find, understand, and apply the information with minimal cognitive effort. In regulatory submission documents and protocols, readability is not optional—it is risk mitigation. High readability:
what’s understood becomes dangerous. The Hidden Cost of Poor Readability Poorly designed documents:
hardest to fix. Readability in technical and regulatory documents is not a cosmetic feature—it is a competitive advantage. As Saul Carliner observed, this is the 2nd level of information design: enabling documents to perform reliably in real-world use. He also suggests that when your documents reduce cognitive strain, you build trust with readers. The most successful submission documents I’ve reviewed are not only scientifically rigorous, they are designed to be read. The Writer’s Responsibility Patricia Wright stresses the author’s role in designing readable documents: “The message is that the onus for achieving successful communication cannot be safely left to the reader. Writers need to see themselves as catalysts for the strategies that their readers adopt; and they need to be aware of the design features that promote the selection of particular strategies.” Wright’s insight shifts accountability squarely onto the author’s shoulders. Too often, medical and regulatory writers assume that expert readers will “figure it out” even if a passage is dense or disorganized. That assumption is dangerous in regulatory contexts, where readers work under time constraints, juggle multiple documents, and must reach reliable conclusions. Readable writing is not about lowering standards—it is about following document design standards as an act of responsibility. Authors shape the strategies readers use and they create conditions that promote consistent, accurate, and rapid comprehension.
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Hyperlinks are everywhere—in protocols, briefing books, submission documents, SOPs, policy manuals, and training guides. Their siren song promises speed, efficiency, and instant navigation.
In Greek mythology, the Sirens’ enchanting melodies lured sailors off course and onto rocky shores. Hyperlinks can work the same way: they invite you to click, to leave the safe harbor of your main discussion or argument in search of something interesting, only to risk losing your place, your context, and sometimes the point entirely. In clinical research protocols, they may link eligibility criteria to lab thresholds, dosing schedules to product handling instructions, or definitions to appendices. For AI and other automated tools, these links are gold: they can map relationships between sections, create a machine-readable network of content, and cross-check for consistency. For human readers, however, hyperlinks come with a trade-off: every link is a micro-decision. When you see a hyperlink, your brain has to ask:
In operational documents like clinical trial protocols, GxP SOPs, or emergency response manuals, these interruptions are more than an inconvenience. They can delay decisions, increase errors, and erode compliance. In regulatory briefing books and Module 2 documents, hyperlink interruptions can undermine both efficiency and precision. Each click risks pulling reviewers away from the main argument, breaking the logical chain that supports a decision. Re-orienting after navigating to annexes, study reports, or external references slows the evaluation process and can erode the clarity of your case. Strategic hyperlinking should serve the narrative—pointing to critical evidence only when it truly strengthens comprehension—rather than scattering attention across disconnected content. Another trap in protocol and submission writing is embedding full source links directly into the main narrative, as if the link itself proves transparency or credibility. In practice, this type of linkage clutters the discussion, distracts the reader, and breaks the flow. Demonstrating a link to source is essential—but the primary text should focus on instruction, reasoning, interpretation, or conclusion. Make the appearance of secondary and tertiary links as subordinate as their intention. Use super script notation to link to footnotes, references, or appendices. The goal is to make these supportive connections accessible without becoming visual speed bumps for your reader. Like the sailors of myth, regulatory and medical writers must recognize when the Sirens are singing. Hyperlinks can be useful guides, but if they tempt the reader away from the main course of the discussion or argument, the hyperlink risks wrecking clarity on the rocky shores of distraction. The safest passage is not to silence the Sirens, but to decide when their song strengthens the voyage—and when it should be left unheard. Why the “Do” Must Precede the Draft in Regulatory Writing
Why do regulatory teams treat Draft 1 like a mirror—something to react to—rather than a blueprint for strategic thinking? Because reacting feels easier than planning. But that shortcut costs time, clarity, and purpose. It’s easier to critique a sentence than to commit to a message. Yet regulatory writing demands something more deliberate: the “do.” The “do” is the document’s core function—what you want the regulatory reader to understand, agree with, or act on. If that function isn’t clear, you’re not writing strategically. You’re just filling pages. When Draft 1 drives the thinking, documents lose purpose—and teams lose time. Real thinking often begins only after Draft 1 is written. By then, the window for deliberate planning has already narrowed. I raised this point with my consulting partner, Stephen Bernhardt. We discussed creating a heuristic tool to guide early drafting. I pushed back: “That assumes teams are willing to think hard before they write.” In my experience, they are not. Most treat Draft 1 as the start of thinking—not the result of it. Medical writers routinely build shells—basic outlines mistakenly called “prototypes” (a separate issue I’ll explore in a future article). These pseudo-prototypes often get ignored. Why?
consequences for silence. The path of least resistance is to do nothing: “I’ll wait for the full draft.” Many teams also delay message planning until the full data set is locked. But by then, it's too late to shape the narrative—only to react to it. Another problem, if leadership doesn’t engage, neither will the rest of the team. Reviewers take their cue from the top. The real issue? Teams skip the pre-draft choices that matter most: defining the document’s purpose, aligning on its message, and designing its logic. Teams avoid thinking about information design—the deliberate structuring of content to make key messages discoverable, logically sequenced, and aligned with the reader’s task. Instead of planning, teams treat the first draft as a mirror—using it to react rather than to think. The Problem: Drafting Replaces Thinking When Draft 1 stands in for strategy, documents suffer. People drop into surface-level edits. They tweak sentences, debate word choices, and micromanage formatting—without questioning the logic beneath it. Few ask: Should this section be saying these things in this way? Fewer still ask: What is this section supposed to do for the regulatory reader? Most cannot answer those questions. I know—because it’s the first thing I ask in every workshop I run. In this dynamic, writing becomes the trigger for strategy, rather than the output of it. When teams treat the draft as a heuristic for meaning, it signals deeper problems:
start rearranging deck chairs on the Titanic—refining detail while ignoring structural failure. A Better Way Forward The fix is simple—but not easy: stop letting Draft 1 lead the thinking. Instead:
Closing Thought When documents are drafted before critical thinking is complete, teams end up managing words—rather than shaping arguments. Regulatory reviewers can feel the difference. I know this from years of feedback and firsthand conversations. Before writing a single sentence, ask:
Writing without purpose isn’t progress. It’s risk. Drug development regulatory submission documents are among the most structured documents in existence—and yet they are often developed in the most chaotic way. As I mentioned in my previous article, teams wait too long to think, treating Draft 1 as the beginning rather than the outcome of deliberate information design planning. Instead of aligning early on logic, purpose, and reader needs, teams begin reacting to prose—often in the form of a partial draft or outline labeled as a “prototype.”. The result? Wasted cycles, misaligned arguments, poor document flow, and late-stage rework that drains time and undermines confidence—especially in mission-critical documents like Clinical Study Reports and the eCTD Module 2.5 Clinical Overview. I suggested in my previous article that development teams need to reconsider what they are generating as document prototypes. Most teams mistake an outline for a prototype. But there’s a key difference:
the establishment of the intellectual architecture of the document. The “So what?” and the “Why?” that are at the core of evaluating, justifying, and arguing. This is the foundation of regulatory writing. After all, the purpose of a submission is not to describe—it is to evaluate, justify, and argue. Those three writing actions sit at the heart of how health authorities assess benefit–risk. From “Primitive Forms” to Design Thinking The word prototype comes from the Greek prototypon—meaning “primitive form” or “original model.” Historically, the concept of building rough models or mock-ups has existed for centuries. However, it was not until the late 1960s that prototyping emerged as a recognized approach in document information design. In software, prototyping gained traction in the early 1970s as an explicit strategy to manage evolving requirements. Winston Royce—often miscredited with creating the Waterfall model—emphasized the importance of incorporating prototyping within code writing to reduce risk. By the 1990s, “document prototyping” became mainstream in many industries that demanded logic and tracebility. Prototyping is not about language and shell tables. It is about early validation of logic, flow, and alignment. A concept that is either poorly understood or undervalued in many Pharma houses. Prototyping as Structured Thinking A real prototype is not a template filled in with placeholder XX, Y% and p-value of 00.0X. A prototype is the framework for judgment. A prototype helps teams clarify what each section must do—not just what it must include. One powerful tool to use is a prototype planning matrix, which breaks down each section into five core elements:  This is the logic scaffold that the decision-making regulatory readers are looking for. Let's walk through an example:  Keep in mind the “So what?” The message is not a study endpoint. The message is a decision in sentence form. The data supports that decision, but the message must guide how the data is presented and evaluated. Teams tell me all the time, “it is all about the data.” I get it. It is indeed about the data. So, during prototyping is the time to make the data needs visible. Where do you need a table, figure, or reference? Too many teams wait until late in the document lifecycle to consider what tables or figures will help carry their argument in a Clinical Overview. Writing Actions and Functional Thinking In my approach, each part of the prototype needs an associated thinking task. What does this section “do” for the reader. It is not about the reporting, it is about the doing:
A strong prototype exposes reasoning, not just structure. It shows how the argument flows, where the evidence lands, and whether the logic holds—before prose locks your thinking into place. ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ New Article: Why Regulatory Writers Need to Prototype Smarter In drug development, we create some of the most structured documents in the world—yet they’re often developed in the most chaotic ways. Too many teams treat Draft 1 as the start of thinking, rather than the outcome of it. In my latest article, I explore why regulatory submission documents—especially eCTD Module 2.5—require prototypes that reveal logic, not just structure. I walk through the difference between outlines and prototypes, introduce a five-part heuristic planning tool, and share examples of how to build prototypes that support decision-making for regulatory readers. It’s not about formatting—it’s about function. It’s not about writing early—it’s about thinking early. Read the full article here: https://www.linkedin.com/pulse/why-regulatory-writers-need-prototype-smarter-gregory-cuppan-solmc Let me know how your team approaches document prototyping—and what gets in the way of doing it well. In regulatory writing, fluency is often praised. To a fault, I might add. Documents that “read well” are
seen as polished, professional, and persuasive. But fluency can be deceptive. A troubling phenomenon is increasingly visible across high-stakes submission documents that I can access: writing that is elegant, but logically unsound. The Problem: Elegant Nonsense These are documents—often Clinical Overviews, Briefing and AdComm Books, or 2.7 Summaries—where the language flows, the sentences vary in rhythm and length, and the vocabulary sounds convincing. But when you interrogate the logic underneath, something’s missing. There is no connective reasoning. The claims float. The evidence is absent, circular, or only loosely linked. I call this elegant nonsense—writing that sounds intelligent but lacks logical structure or evidentiary support. Examples of Elegant but Hollow Writing
high-stakes submission documents? Why This Happens
Why It is Dangerous Regulatory readers are trained to look beyond the language. They must detect bias, weigh risk, evaluate strength of evidence, and make yes/no decisions under pressure. When documents rely on polished language to mask weak thinking, reviewers lose confidence—not just in the section, but in the entire argument. This is the affective level of information design, as suggested by Saul Carliner. Carliner noted that when writing feels effusive (demonstrative, lavish) or evasive, then the writing erodes the reader’s trust—not only in what is stated, but in why it is stated that way. In regulatory contexts, that erosion is consequential: it casts doubt on the sponsor’s judgment and forces the reviewer to work harder to separate signal from gloss. Elegant writing that lacks rigor is not just ineffective—it can be misleading. How to Spot and Fix It Interrogate every conclusion – What is this based on? Where’s the data? Is the reasoning clear? Replace vague synthesis with structured logic – Instead of “Taken together,” show how the pieces fit. Simplify to clarify – If the sentence reads like corporate poetry, ask: is it hiding uncertainty? Separate fluency from function – Does this paragraph sound good, or does it do its job? Consider the phrase: “This study is adequate and well-controlled.” The phrase appears routinely in regulatory documents—concise, confident, and aligned with regulatory guidance language. But unless the concepts are substantiated, this sentence is nothing more than elegant shorthand. Why It Sounds Smart It mimics the regulatory lexicon (such as 21 CFR 314.126). It conveys confidence in the study's design. It’s often used to bridge to conclusions about efficacy or labeling claims. Why It May Be Elegant Nonsense If the surrounding text contains no analysis of the “whys” for:
must move from elegance to substance. Another Example: “The Safety Profile Was Manageable” This phrase shows up in nearly every Clinical Overview and Summary of Clinical Safety I read. The phrase suggests confidence, but what does it actually mean? Why It Sounds Smart It’s concise and optimistic. It implies clinical actionability—something prescribers and regulators care about. Why It May Be Elegant Nonsense “Manageable” sidesteps reasoning. The term offers a verdict without evidence. I suggest that without explaining what was managed and how, this phrase is:
informative work. “Manageable” carries a positive emotional valence (“feel good factor”) without conveying analytical substance. It is language designed to reassure, not inform. Bottom Line Polished phrases like “adequate and well-controlled” or “manageable safety profile” only serve the reader when tethered to evidence and logic. Elegant language that obscures complexity—or avoids specifics—undermines trust in the message. In regulatory writing, clarity must be earned. You make a claim, you better prove it. A Better Standard The goal of regulatory writing is not to sound polished. The goal is to communicate rationales for interpretations and decisions—clearly, truthfully, and logically. Regulatory decisions shape public health. Regulatory reviewers must decide under pressure, with limited time. Our job as writers is not just to report and write elegant prose—but to demonstrate thinking on the page. Writing that hides uncertainty or skips reasoning does not just fail the reader. It fails the process.
Also published to LinkedIn July 2, 2025. https://www.linkedin.com/pulse/when-elegant-writing-masks-flawed-thinking-regulatory-gregory- cuppan-qmmrc In my observation of efforts to embrace lean writing across regulatory submission documents, I find a troubling trend has emerged: I am seeing lazy writing, not lean writing.
Pharma clients are increasingly voicing concerns that critical content—especially in key “end-game” submission documents like Module 2.5—is being trimmed so aggressively that essential context, rationale, and reader guidance are vanishing altogether. In some submissions, a placeholder sentence has replaced the entire substance of a required overview discussion. For example I have found the following in a Clinical Overview I was asked to review: "For Pop PK, refer to Section 2.7.3.x. Where the text states: No concerns regarding intrinsic or extrinsic factors. For full details, refer to 5.3.3.x." This is not lean writing. This is abdication. I expect the discussion of Pop PK in the Clinical Overview to provide a concise but informative synthesis that supports the understanding of dose selection, variability, and applicability across patient subgroups. I want a high-level summary on the data sources and modeling approach. I do not want to leave the document to learn these details. Remember, the busy, selective regulatory reader's needs are immediate, not later. Give me the "So what?" here and I will decide if I want to follow the link. Cutting to the Bone (or Into It) The intent of lean writing is to eliminate noise, not substance. Lean writing means focus on what a section is to “do” and what is the “So what?”. Lean writing is about reducing clutter—repetition, irrelevance, hedging, verbosity—not impacting clarity, logic, or the reader’s ability to understand, navigate, and assess. The "write it once and refer" principle does not mean we get to skip the responsibility of previewing what is important, or overviewing the details that support the “So what?” and why the details matter. Lean Writing Is a Reader-Centered Discipline Lean writing is not about writing less—it is about writing smart. Lean writing designs information to reflect reading behavior. Lean writing anticipates the reader’s questions and designs plans to provide a clear response. The lean writing style builds scaffolding within a section so the reader can move efficiently from “So what?” overview to evidence and analysis. Lean writing provides the mental handles that allow the reader to judge the relevance, reliability, and meaning of the details found elsewhere. Lean writing reduces noise, not meaning. And meaning needs structure, context, and care. Hyperlinking without context and care for the reader is not lean. It is lazy. The busy, decision-making regulatory reviewer is not looking for breadcrumb trails. They are looking for clarity, logic, and confidence that you, the Sponsor, got the “So what?” right. https://www.linkedin.com/pulse/lean-writing-what-we-want-lazy-gregory-cuppan-etufc You’ve heard it before: plain language is essential to effective regulatory communication. I have
discussed this topic many times—writing that avoids jargon, long sentences, and convoluted phrasing improves readability. But here is the problem: plain language does not always help the reader understand what matters—or what to do with the information. A sentence may be grammatically simple, technically correct, and jargon-free—and still be useless to a regulatory reviewer or clinical research manager trying to make a decision. Clarity is not just about words. It is about what those words are doing. That is, the action of meaning. Action of meaning refers to how writing should do more than just state facts. The action within writing is shaping how facts are understood. The approach involves selecting, organizing, and connecting information so that the reader grasps why it matters. In regulatory writing, the action is to turn data into insight and support decision-making. Plain language is necessary—but not sufficient. To achieve true clarity in regulatory documents—especially those designed to inform regulatory judgment—we need more. We need writing actions: carefully orchestrated rhetorical moves that position, prioritize, and connect information with intent. What Are Writing Actions? Writing actions are deliberate moves that shape how information is delivered. Each action—such as previewing, overviewing, summarizing, and synthesizing—serves a distinct purpose, helping the reader understand what’s being said, why it matters, and how to act on it. These actions give structure and direction to plain language text. The actions guide attention and support decisions. What Plain Language Does Well When done well, plain language:
Where Plain Language Falls Short Even a well-written sentence can feel out of place if it does not:
In the book I co-wrote with Stephen Bernhardt --Writing for the Biopharmaceutical Regulatory Reader (2nd Edition)—we dedicate over 60 pages to discussing 11 writing actions. We consider these actions to be the rhetorical moves that turn information into insight. Four Writing Actions That Boost Clarity 1. Preview Previewing sets expectations. The writing action is a “framing” technique. The action positions the reader to absorb the information with the proper context and connect it to the larger purpose of the document. Example: This section evaluates the safety profile of the investigational monoclonal antibody using pooled data from five 26-week studies conducted in North America, Europe, and East Asia. The focus is on treatment-emergent adverse events, serious infections, and discontinuations. Data from subgroups—by age, comorbidity, and prior biologic use—are also included to support regulatory interpretation of risk across diverse patient populations. Why it works:
review team. Example: This document discusses the relevant data from individual studies leading to the approvals of nivolumab and pembrolizumab for the first-line treatment of unresectable or metastatic HER2-negative gastric adenocarcinoma as well as the data submitted to support approval of tislelizumab for the same indication. The aggregated experience with these independent trials and products provides a framework to discuss the strength of evidence for PD-L1 expression as a predictive biomarker for patient selection in this patient population, differing risk-benefit assessments in different subpopulations defined by PD-L1 expression, and adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression. Why it works:
2. Overview Overviews are selective, not comprehensive. Overviews highlight the most important ideas in a document, section, or dataset. The writing action is to orient the reader to the "So what did we learn?" message or key findings. Overviews often use interpretive language that signals importance but defers delivery of precise numerical support to later sections of the document. Example: The clinical trials have demonstrated DTG’s antiretroviral activity and safety in various settings. Key safety observations include:
structure of the content that follows. Summaries come later—they distill key details after the content has been presented. 3. Summary and Synthesis: Writing Actions That Inform If preview and overview frame, then summary and synthesis inform. These writing actions appear after data presentation to help the reader interpret and apply what they have just consumed. Summary distills the most important details. A summary does not repeat the data—it distills and prioritizes. Summaries help readers confirm “So what?” messages, locate key conclusions, and prepare for comparison across family or families of data. Synthesis goes further. This writing action is all about connection. The writing action links evidence across trials, endpoints, or populations—identifying relationships, patterns, and meaning. Synthesis is essential when articulating benefit-risk tradeoffs, justifying dose, or drawing conclusions across complex data sets. Together, these actions help readers move from detail to decision. Summarizing and synthesizing are not reporting—the actions are to distill and contextualize. Final Word: Activate Plain Language with Purpose Plain language improves reader access, but writing actions give meaning and direction to language. Preview and overview frame expectations and focus attention. Summary and synthesis inform the reader—distilling evidence, revealing connections, and guiding decisions. Together, these writing actions coupled with plain language writing make regulatory documents clearer, faster to navigate, and more useful to those who must act on them. Clarity in regulatory writing is not only about managing paragraphs, sentences, and words. It is about activating them with purpose. That is, enabling the action of meaning.  Regulatory writing is often misunderstood as simply the ability to craft technically correct, well-structured sentences and to organize content within templates. In reality, great regulatory writers are strategic thinkers, skilled analysts, and expert communicators who bridge science and regulatory expectations.
While strong writing is foundational, what truly sets great regulatory writers apart is their ability to think like regulatory reviewers. Many of you reading this article have heard me say in workshop sessions that “every great writer is always thinking about their reading audience and what their audience needs in documents to facilitate decision-making.” Great regulatory writers bring scientific fluency, regulatory insight, information design skills, and a deep understanding of how health authorities read and decide. Scientific and Regulatory Fluency Great regulatory writers do not just write about science—they understand it. Their fluency spans:
While an average writer transcribes and rewords SME input, a great writer interrogates the data, anticipates regulatory questions, and frames key arguments. They engage SMEs with targeted questions, uncover rationales, test assumptions, and shape content into precise, persuasive messaging. Collaboration becomes a strategic dialogue—not just an information handoff. Strategic Thinking and Persuasion Regulatory briefing books and Module 2 dossiers are not neutral summaries—they are interpretive and often persuasive instruments. Whether drafting a Clinical Overview or responding to agency queries, great writers shape how the data is understood and weighed. That’s where advanced writing actions come in:
From Data to Knowledge: Mastering the Continuum Perhaps the most critical competency of great regulatory writers is transforming data into regulatory knowledge—a progression essential to support effective regulatory decision-making:
implications of the data—and how those implications align with policy, precedent, and public health goals. Information Design: Optimizing for Decision-Making Great regulatory writers are also information designers. They understand how layout, structure, and hierarchy support—or hinder—regulatory decision-making. Good information design lowers cognitive load and accelerates comprehension. Great writers adapt their approach based on document type, review timelines, and information volume. They help regulatory readers by:
Final Thought: Great Writers Think Beyond Writing The best regulatory writers are not just technical specialists. They are strategic partners who combine writing with science, persuasion, design, and foresight. They transform information into knowledge—and knowledge into action. Check out my LinkedIn to see what others are saying about this article: https://www.linkedin.com/in/gregorycuppan/ A few weeks ago, during a workshop on lean writing for regulatory submissions, I was hit with this
challenge from a participant: “Greg, we overload documents with details and redundancies because of the huge FDA Medical Review Officer (MRO) turnover. We need to make it easy for new people. New reviewer, limited context—we’ve got to give them the story in one place.” He cited some details that I’ve since seen echoed elsewhere:
High turnover isn’t an argument for long, dense documents—it’s an argument for leaner ones. Why?
weigh in with his thoughts: Steve commented, The upside is your workshop participant is thinking about the reviewer’s situation—and that’s good. But let’s flip the logic. If I’m new to a review, I don’t want more content. I want better content. What does “better” look like? I suggest the following:
rapid comprehension. And here’s a question I often asked development teams when consulting: “When you’ve been new to a project, what helped you get up to speed? What slowed you down?” I cannot recall anybody telling me: “Longer documents would’ve helped.” Greg (closing thought): I understand how people worry that lean writing leaves out what they believe is essential context. We are dealing with conditioned behavior built up in people who are used to seeing obese documents. But the real risk is this: bloated documents make it harder for new reviewers to find what they are looking for, understand the “So what?” and then take action—that is, make a decision. Steve (closing thought): Let's trust our instincts that tell us that often less is more and that busy readers will thanks us for documents that are designed to help them make good decisions. What do you think? Have you faced similar pushback when advocating for lean regulatory writing? How do you respond to the “but reviewers need everything in this document, we gotta be transparent, we gotta make it easy for them by putting everything in one place” argument? Please share your thoughts. The Impact of ICH E6 (R3) on Protocol Development – Practical Implications for Protocol Writers4/3/2025 also published on LinkedIn March 16, 2025
The recently published ICH E6 (R3) Good Clinical Practice guidance is set to bring significant changes to the development of clinical trial protocols. The European Medicines Agency (EMA) has adopted E6(R3) Principles and Annex 1 to take effect on July 23, 2025. Other ICH member nations and regions are still in the process of considering E6(R3) implementation. Additionally, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later this year. As the biopharmaceutical industry continues to evolve toward more complex and adaptive study designs, clinical development teams and protocol writers must align expectations and approaches with these new regulatory expectations. Understanding the key updates in ICH E6 (R3) and their practical implications in enhancing protocol clarity, compliance, and efficiency is essential for those involved in protocol development. Key Changes in ICH E6 (R3) The primary goal of ICH E6 (R3) is to modernize GCP guidance by emphasizing quality by design, risk-based approaches, and data integrity. The guidance states the following:
Some of the major (R3) updates that impact protocol development include:
To align with these changes, protocol writers must consider the following concepts: Structuring Protocols with a Risk-Based Mindset
Enhancing Clarity in Monitoring and Data Collection Plans
Addressing Decentralized and Adaptive Study Considerations
Strengthening Patient-Centered Language and Accessibility
Conclusion ICH E6(R3) ultimately aims to improve trial efficiency, participant experience, and data reliability. Protocol writers will play a critical role by translating these updated regulatory expectations into clear, actionable, and compliant documents. |
AuthorGregory Cuppan is the Managing Principal of McCulley/Cuppan Inc., a group he co-founded. Mr. Cuppan has spent 30+ years working in the life sciences with 20+ years providing consulting and training services to pharmaceutical and medical device companies and other life science enterprises. 
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