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  • What If AI was a…BLANK: A Hypothetical IRB Nightmare

    What If AI was a…BLANK: A Hypothetical IRB Nightmare

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    The IRB Coordinator’s Diary | The Raw Side of Research Ethics and Compliance.

    Whether you’re a seasoned professional or an IRB novice, everyone can learn something from The IRB Coordinator’s Diary.

    DISCLAIMER: Consider topics in this newsletter as food for thought. This is meant to be an educational resource only. This is NOT meant to provide legal advice or replace guidance provided by your institution. You should always consult your institution for specific practices related to research compliance or any legal subject matter presented in this newsletter.

    Dear diary (and everyone else reading my diary),

    Movies like M3GAN have shown us the dangers if AI was an entity that lived among us like other humans. But…what if we aren’t far from this becoming reality? What if AI entities and humans had to coexist? And if we were to coexist, what does this mean for the future of research within the regulatory landscape?

    This article will explore a hypothetical nightmare for IRBs if AI entities lived among us. Specifically, we will explore the if AI was a:

    • Principal investigator conducting human subjects research,
    • Participant in a human subjects research study, or a
    • Reviewer of human subjects research.

    Before we get started, I encourage you to please share this newsletter with your network and subscribe.

    Table of Contents

    AI as a Principal Investigator (PI)

    Imagine an AI serving as a PI on a human subjects research study. At first glance, this might sound appealing. An AI PI (admit it, you laughed too) could theoretically:

    • Process vast amounts of literature in seconds,
    • Generate research protocols almost instantly, and
    • Never miss a deadline.

    However, the regulatory landscape becomes considerably more complicated when the individual responsible for protecting human subjects is not actually human.

    Current regulations place responsibility and accountability squarely on the shoulders of a human PI. When protocol deviations or adverse events occur, a human is held accountable. But what happens when the PI is not a human?

    • Can an AI PI truly exercise ethical judgment when unexpected situations arise?
    • Can an AI PI weigh competing interests, recognize subtle signs of participant distress, or make decisions that prioritize participant welfare over study outcomes?
    • Who bears responsibility when things go wrong: the institution, the developer of the AI PI, or the AI PI?

    Perhaps the greatest challenge for IRBs would be determining whether an AI can satisfy the fundamental expectation that investigators respect and protect human subjects.

    Regulations imply that PIs possess not only expertise but also a moral compass that guides them in conducting responsible human subjects research.

    While AI may be capable of following rules, it remains unclear whether it can genuinely understand the ethical principles underlying them (let alone human emotions such as distress). The nightmare scenario for IRBs is not an AI that intentionally acts unethically. It is an AI that follows every instruction perfectly while missing the human element that ethical research demands.

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    AI as a Study Participant

    Now consider the opposite scenario: an AI entity enrolled as a participant in a human subjects research study.

    You would think the idea of AI serving as a research participant sounds like science fiction. Yet researchers are already encountering versions of this reality. In a 2024 qualitative research study, investigators unexpectedly discovered AI-generated responses within their dataset while conducting online research. The authors described the challenge of identifying “AI-as-participant” responses and raised concerns about how generative AI may blur the line between genuine human participation and artificial responses. As AI becomes increasingly capable of producing human-like narratives, researchers may find it difficult to determine whether they are collecting data from people, machines, or potentially both.

    At the same time, some scholars are exploring whether AI can intentionally serve as a participant substitute. A recent study proposed using trained AI systems as experimental participants in behavioral and economic research, allowing investigators to create simulated participant groups that serve as rational, bias-free, or otherwise controlled comparison populations. It’s argued that AI participants could reduce recruitment costs, accelerate studies, and help researchers test hypotheses under conditions that would be difficult or impossible to create with human subjects alone.

    For IRBs, this creates a fascinating regulatory dilemma.

    • If AI-generated responses are mixed with human data, what obligations do investigators have to disclose this to participants?
    • If researchers intentionally use AI participants, is the resulting activity still human subjects research?

    The nightmare scenario is not necessarily an AI entity demanding informed consent or asserting legal rights.

    It’s a future where human participants and artificial participants become blurred.

    IRBs may find themselves reviewing protocols where the central question is no longer how to protect human subjects, but how to preserve the scientific validity, transparency, and integrity of research where participants may not always be human.

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    AI as an IRB Reviewer

    AI serving as an IRB reviewer may be the closest scenario in which AI entities truly become reality. Regulatory agencies are already experimenting with AI-assisted workflows. FDA’s Elsa 4.0 was developed to help agency staff analyze, summarize, and navigate large volumes of information. Likewise, recent research such as Chat-IRB for LMICs: an opportunity for ethics review capacity-building and protection against ethics dumping, IRB shopping, and other exploitative research practice has proposed supporting IRB operations. Rather than replacing reviewers, these systems would provide assistance.

    Anyone who has served on an IRB knows that committees routinely face increasing workloads, complex protocols, and pressure to provide timely reviews. An AI reviewer could instantly identify missing consent elements, compare protocols against institutional requirements, flag inconsistencies across submissions, and surface relevant regulations or precedent decisions. In an interview discussing the Chat-IRB concept, the author emphasized that properly designed systems could help standardize reviews, reduce administrative burden, and allow reviewers to focus their attention on the most challenging ethical questions rather than routine compliance checks.

    But this is where the hypothetical nightmare begins.

    Imagine a future in which an AI reviewer becomes so accurate and efficient that committees increasingly defer to it by default. Over time, reviewers may not introduce varying perspectives. The danger isn’t that the AI reviewer would ignore regulations.

    The danger is that IRB review is not solely about regulatory compliance.

    It requires judgment about fairness, community values, participant vulnerability, and whether a study respects the individuals it seeks to enroll. Ironically, the more reliable AI becomes, the easier it may be for humans to disengage from the very ethical deliberation that makes IRBs valuable. The future challenge for IRBs may not be deciding whether to coexist with these AI entities but determining how much ethical authority should ever be delegated to it.

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  • Mastering Clinical Research and Career Growth in a Rapidly Changing Industry

    Mastering Clinical Research and Career Growth in a Rapidly Changing Industry

    Alec Spinelli – an Author and Educator

    Table of Contents

    Tell us about your background and your motivation behind writing these series of books.

    Alec Spinelli is a seasoned Clinical Research Author, Clinical Project Manager, Clinical Educator and Speaker with nearly 20 years of clinical research industry experience and 26 years in healthcare. He has led global trials across Phases Iโ€“IV and held key roles at sponsor and CRO companies, including Sr. CRA, Lead CRA, Clinical Trial Manager,  Clinical Team Lead, and Project Manager. He is currently a Start-up Project Manager at Fortrea CRO.

    Alec holds an MBA in Business Management from Liberty University, completed his graduate studies in Biomedical Engineering at Rutgers University, and earned a B.A. in Biology. His blend of hands-on experience, academic insight, and investment in continuing education make his books an essential resource to understanding and navigating clinical research for patients, families, and clinical research professionals at all levels.

    My motivation for writing my clinical research book series came from years of answering questions from colleagues and LinkedIn connections about career growth, ICH-GCP, regulatory compliance, and clinical trial operations. I wanted to create practical, concise resources that simplify complex topics and help professionals confidently navigate and advance within clinical research.

    You can see all current books available for purchase on Amazon:

    Amazon.com: Regulatory Affairs in Global Clinical Research : A Comprehensive Look at FDA, EMA, PMDA, MHRA, and Other Global Regulatory Pathways for Trials and Submissions eBook : Spinelli, Alec: Kindle Store

    Amazon.com: ICH – GCP E6(R3) Comprehensive Resource Guide for Clinical Research Professionals: Practical Insights and Key Updates for Clinical Study Design and Application eBook : Spinelli, Alec: Kindle Store

    Amazon.com: Informed Consent Made Simple – Forms, Purpose, and Practice in Clinical Research: A Comprehensive Guide to What Patients and Families Need to Know and What Professionals Must Understand eBook : Spinelli, Alec: Kindle Store

    Amazon.com: Mastering Clinical Trials: Essential Knowledge for Clinical Research Professionals : The Comprehensive Reference Manual for Clinical Trial Methodology and Real-World Research Applications eBook : Spinelli, Alec : Kindle Store

    Amazon.com: Institutional Review Board (IRB) Made Simple – the Purpose, Process, and Scope of the IRB in Clinical Research: A Comprehensive Guide to the IRB for Patients, Families and Professionals eBook : Spinelli, Alec: Kindle Store

    Amazon.com: Clinical Research The Best Career You Never Heard Of 10 Reasons to Get Into the Research Industry NOW eBook : Spinelli, Alec: Kindle Store

    Amazon.com: How to Snag that First Clinical Research Job: A Concise Guide for ANYONE to Preparing, Interviewing, and Landing that First Clinical Research Job (How … Research Career Blueprint Book Series 1) eBook : Spinelli, Alec: Kindle Store

    Amazon.com: How to Snag That First Clinical Trial Manager Job: A Concise Guide to Preparing, Interviewing, and Landing that First CTM Job You’re After (How to Snag … Research Career Blueprint Book Series 4) eBook : Spinelli, Alec: Kindle Store

    Amazon.com: How to Snag That First CRA Job 2nd Ed: The Updated Guide to Landing that First CRA Job Youโ€™re After (How to Snag That First – The Clinical Research Career Blueprint Book Series) eBook : Spinelli, Alec: Kindle Store

    Amazon.com: How To Snag That First Senior Clinical Research Associate Job 2nd Ed: The Updated Guide to Landing that First Sr. CRA Job Youโ€™re After (How to Snag That … Research Career Blueprint Book Series 3) eBook : Spinelli, Alec: Kindle Store

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    Why do you think the clinical research industry still has such low visibility despite its enormous impact?

    I think clinical research often carries an air of mystery, making it seem inaccessible to those unfamiliar with the field. Many people have never heard of clinical research or interacted with it until a family member, close friend, or loved one becomes sick and begins exploring treatment options. At that moment, clinical research can suddenly become very personal.

    People also assume it requires a medical degree or years of specialized training, but the truth is far more inclusive. Clinical research welcomes professionals from diverse backgrounds, offering pathways for individuals with experience in healthcare, science, and even nontraditional fields to contribute meaningfully to advancing medicine.

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    Why is it so difficult for candidates to land that first clinical research role?

    One of the fundamental challenges in entering the clinical research field is the competitive nature of the job market. With so many individuals seeking to break into this rewarding profession, it’s essential to differentiate yourself.

    Knowing about the industry is only half the battle. The other half lies in preparation, where developing the skills, gaining the experience, and crafting the narrative you need to make employers see you as a perfect fit.

    From understanding the foundational knowledge required for clinical research roles, including specific therapeutic area, regulatory, start-up, clinical operations, data management, etc., to crafting a resume highlighting your most relevant strengths, and ways to leverage your existing skills, even if your background isn’t directly in clinical research.

    These are factors that must be addressed when seeking to break into a first-time clinical research role.

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    What do hiring managers prioritize versus what applicants think matters in terms of someoneโ€™s CV and skills?

    Many applicants believe hiring managers only focus on certifications, titles, or years of experience, but hiring managers often prioritize quantifiable results, adaptability, communication, reliability, problem-solving, and whether someone can work effectively within cross functional team.

    A strong CV certainly matters, but employers also look for candidates who understand clinical trial operations, can think critically, and demonstrate professionalism. In clinical research especially, attitude, responsiveness, and the ability to learn and adapt quickly can sometimes outweigh having a great background on paper. More recently, hiring managers are also looking for the ability to utilize AI tools and systems effectively to execute trials successfully.

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    What do people misunderstand most about the Clinical Research Associate (CRA) role before entering it?

    I think one of the biggest misunderstandings about the CRA role is that people think it is mostly travel and site visits. Another very frequent misconception is that it is an entry-level position.

    In reality, the CRA role typically requires prior clinical research experience and a strong understanding of monitoring, trial oversight, regulations, and site operations.

    While travel can be a major part of the role, CRAs are also responsible for communication, documentation review, problem-solving, and protecting patient safety and data integrity. Success often depends on organization, adaptability, critical thinking, and the ability to manage complex relationships across multiple studies and sites.

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    What is the biggest mindset shift when moving from CRA to Clinical Trial Manager (CTM)?

    One of the biggest mindset shifts when moving from a CRA to a CTM role is transitioning from primarily overseeing individual tasks and sites to leading the broader strategy and execution of an entire clinical trial.

    A CRA often focuses on monitoring and site-level oversight, while a CTM must think more globally across timelines, budgets, vendors, cross-functional teams, and operational risks. The role requires stronger leadership, communication, and decision-making skills, along with the ability to balance competing priorities while keeping the study moving forward efficiently and compliantly.

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    What do you see as the most important philosophical shift in ICH-GCP E6(R3)?

    I believe the most important philosophical shift in ICH-GCP E6(R3) is the stronger emphasis on Quality by Design (QbD) and proactive risk management rather than relying heavily on retrospective correction and excessive documentation.

    The updated guidance encourages organizations to build quality into clinical trials from the beginning by focusing on critical processes, patient safety, and data integrity.

    It reflects a more modern, flexible, and practical approach to trial oversight that better supports innovation, decentralized trials, technology integration, and real-world operational challenges across global clinical research.

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    I believe informed consent forms (ICFs) have become far too complex for the average patient and even overwhelming for many experienced healthcare professionals.

    While the intent is to protect patients and ensure transparency, many ICFs are now filled with dense legal, medical, and regulatory language that can make true understanding difficult.

    Patients are often reviewing these documents during stressful and emotional moments in their lives. That was one of the main motivations behind writing my book, โ€œInformed Consent Made Simple.โ€ I wanted to create a practical resource that helps patients, families, and professionals better understand the purpose, process, and real-world importance of informed consent in clinical research.

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    How do you think AI will reshape clinical operations over the next five years?

    I believe AI will significantly reshape clinical operations over the next five years by helping augment many routine, simple, and time-consuming tasks.

    AI systems will likely assist with the Trial Master File (TMF) index construction and review, protocol summarization and analysis for site ID, and first-pass QC reviews of essential records, helping reduce administrative burden and improve efficiency.

    Rather than replacing clinical research professionals, I believe the workforce will shift its focus toward more complex responsibilities involving oversight, strategy, decision-making, relationship management, and patient-centered activities that still require strong human judgment and experience.

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    If someone wants to enter clinical research this year, what should they do first?

    If someone wants to enter clinical research this year, the first thing they should do is review the top entry-level research roles and identify which pathway best aligns with their background, interests, strengths, and long-term goals.

    Not every entry point is the same, and understanding where they fit best is critical. Next, they should build a strong foundation in general clinical research knowledge and then focus specifically on the responsibilities and expectations of their desired role.

    This helps them craft a targeted resume that highlights transferable skills, relevant strengths, and how their existing experience can provide value to the company and clinical trial team. They should also ensure they understand use and application of AI in clinical research as this is becoming an increasingly essential skill in our industry.

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    We’d like to thank Alec for sharing his resources and expertise to the S.P.I.R.I.T. community!

  • Top 2026 Research Administration and Compliance Conferences

    Top 2026 Research Administration and Compliance Conferences

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

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    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Authored By: Tasha Mohseni

    Happy New Year and welcome to the first CREST blog post in 2026!

    It feels good to get back on the saddle and write to you all. I hope you all enjoyed the holidays with your family and loved ones.

    I wish that 2026 brings you all success, good health, and whatever you were working towards last year that will be worthwhile.

    people lighting sparklers

    For today’s article, I’d like to highlight top research administration and compliance conferences. These are events you don’t want to miss to develop professionally!

    IMPORTANT: Events within this article were included only if they were a “conference” or “annual meeting” (i.e., no other event types such as workshops or webinars).

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    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

    Table of Contents:

    Research Administration and Compliance 2026 Conferences Summary

    OrganizationAnnual Conference(s)Information Available?
    WCGMAGIYes, 2026 information is available.
    Public Responsibility in Medicine and Research (PRIM&R)PRIM&RYes, 2026 information is available as well as a call for session proposals.
    Northwest Association for Biomedical Research (NWABR)1. IRB, IBC, & IACUC Conference

    2. Clinical Research Professional Conference

    3. CyberBIO    		Only a call for 2026 session proposals for each conference (as of 1/3/26).
    Association of Clinical Research Professionals (ACRP)ACRPYes, 2026 information is available.
    Society of Clinical Research Associates (SOCRA)1. Clinical Research Project/Program Management Conference

    2. Quality Management Conference

    3. FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference

    4. Pediatric Clinical Trials Conference    		No information at this time (as of 1/3/26).
    National Council of University Research Administrators (NCURA)1. Annual Meeting of the Membership

    2. Financial Research Administration Conference

    3. Pre-Award Research Administration Conference    		For two conferences, 2026 information is available (as of 1/3/26).
    SCOPESCOPE 2026Yes, 2026 information is available.
    Society of Research Administrators (SRAI)1. Annual Meeting

    2. Financial Management

    3. Research Administration Conference    		Yes, 2026 information is available..

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    WCG’s MAGI Conference

    MAGI is a WCG event that connects clinical research professionals who are committed to ensuring the quality, compliance, and efficiency.

    Per the website, WCG is a partner to research sponsors, CROs, sites and participants in navigating the clinical research journey. WCG showcases their solutions in exhibit booths at various conferences. Further, they offer informative webinars (especially if you’re new to clinical research. You can view the following links below for educational materials:

    Upon review of the MAGI 2025 conference…

    • Five education tracks were offered including:
      • Budgets: learning the nuances of ensuring your site is optimized for conducting clinical trials
      • Contracts: exploring field-tested, easily implemented negotiation tools and techniques that can help maintain control, improve turnaround times, and reduce last-minute scrambles
      • Billing compliance: strengthening research billing compliance development and program oversight
      • Quality and regulatory: ensuring adherence to the regulations on research participant protections
      • Clinical operations: mastering approaches to maintaining trial quality and effective tactics for protecting participant safety and data integrity
    • You can review the 2025 agenda to view workshops within these educational tracks

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    PRIM&R Annual Conference

    The PRIM&R Conference educates those involved in research and research oversight to support and achieve the advancement of ethical, responsible, and high-quality research.

    PRIM&R is a nonprofit,โ€ฏfounded in 1974 that works to ensure the highest ethical standards in research by:

    • Providing education,
    • Membership, and
    • Other professional resources to the research and research oversight community, including those who work with:
      • Human research protections programs (HRPPs),
      • Institutional review boards (IRBs),
      • Animal care and use programs,โ€ฏand
      • Institutional animal care and use committeesโ€ฏ(IACUCs).

    Those who attend these conferences can use the session materials in preparation for the following certifications:

    Upon review of the 2025 PRIM&R Annual Conference…

    This also includes the PRIM&R Social Behavioral Educational Research Conference (SBER25). Attendees have the choice to either:

    • Attend PRIM&R 2025 only
    • Attend SBER 2025 only
    • Attend PRIM&R 2025 and SBER25

    Educational tracks range from program administration, regulation-specific topics, quality control, post approval monitoring, emerging challenges, and many more!

    You can also submit proposals to speak at PRIMR26!

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    NWABR Annual Conferences

    NWABR offers three annual conferences and is currently accepting 2026 submissions.

    NWABR is dedicated to promoting the public’s trust in ethically conducted biomedical research. You can read more about this organization here: About Us.

    IRB, IBC & IACUC Conference Series

    This conference is PERFECT if you wear multiple compliance hats or in a small HRPP.

    You can review the 2025 program to see the various topics within these compliance areas.

    Clinical Research Professional Conference Series

    This conference is for clinical research professionals who ensure the ongoing integrity of research within their institutions.

    You can review the 2025 program to see this year’s focus: quality initiatives and artificial intelligence (AI)

    CyberBIO Conference Series

    This conference includes experts across government, industry, and academia to discuss issues at the intersection of biomedical sciences and cybersecurity.

    You can review the 2025 program once it is available (as of 9/23/25).

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    ACRP Annual Conference

    ACRP is a registered charitable organization whose mission is to promote excellence in clinical research.

    Their vision ensures that clinical research is performed ethically, responsibly, and professionally everywhere in the world. 

    The ACRP 2026 website is available!

    Educational tracks for this year’s conference include:

    • Clinical operations
    • Study and site management
    • Regulatory/quality
    • Innovation and change management
    • Workforce and professional development

    Those who attend these conferences can use the session materials in preparation for certification:

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    SOCRA Annual Conferences

    SOCRA is a non-profit, charitable and educational membership organization incorporated in 1991 committed to providing:

    • Education,
    • Certification, and
    • Networking opportunities to all persons involved in clinical research activities.

    Those who attend these conferences can use the session materials in preparation for the following SOCRA certification:

    Clinical Research Project/Program Management Conference

    This conference is designed to introduce, affirm, or elevate your understanding of project management in the field of clinical research.

    The program will broaden the participantsโ€™ knowledge of the regulatory framework, project management, planning and accounting, and achieving successful clinical trials. For more details, you can review:

    Quality Management Conference

    This conference provides insights, practical tools, and real-life examples to navigate quality planning, control, assurance, and improvement in clinical research. 

    The event delivers vital information on developing and implementing effective quality management systems in line with FDA Regulations and ICH guidance. For more details, you can review:

    FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference

    This conference is designed to aid in the understanding of the FDA’s mission, responsibilities and authority and to facilitate interaction with FDA representatives.

    The conference will focus on:

    • FDA Clinical Research Requirements,
    • Enhancing Success through Communication, and
    • Financial Incentives, and Assuring Confidence in Clinical Research

    For more details, you can review the program’s learning objectives and 2025 agenda.

    Pediatric Clinical Trials Conference

    This conference will improve professional skills and understanding of the responsibilities of conducting clinical research in the pediatric population. 

    This program is designed to elevate attendees’ understanding and application across the:

    • Regulatory environment,
    • Informed consent and assent,
    • Recruitment and retention,
    • Feasibility,
    • Budgeting,
    • Contracting, and
    • Financial management

    For more details, you can review the program’s learning objectives and 2025 agenda.

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    NCURA Annual Conferences

    NCURA offers three annual conferences!

    NCURA is a non-profit professional society dedicated to advancing the profession of research administration through:

    • Education and professional development programs, the
    • Sharing of knowledge and experiences, and the
    • Fostering of a diverse, collegial, and respected global community. 

    Annual Meeting of the Membership

    This conference is held each year in August in Washington DC with workshops prior to the main event!

    Various tracks and sessions relate to:

    • Pre-Award,
    • Post-Award,
    • Compliance,
    • Departmental,
    • Global,
    • Predominantly Undergraduate Institutions,
    • Clinical Trials/Research, and
    • Career-Skills

    You can review the 2025 program schedule for specifics related to the conference sessions.

    Financial Research Administration Conference

    This conference is for those who work in the financial administration of research, specifically to discuss post-award issues.

    Various tracks relate to:

    • Accounting, Finance & Costing
    • Clinical/Medical
    • Financial Compliance/Audit
    • PUI
    • AI/Data/ERA/Systems
    • Departmental
    • Global
    • Workforce, Wellness & Resilience
    • Career Development
    • Federal
    • Pre-Award for Finance

    You can review the 2026 program information here.

    Pre-Award Research Administration Conference

    This conference complements the conference mentioned above; however, pre-award issues are discussed.

    Various tracks relate to:

    • Clinical/Medical/Industry
    • Departmental
    • Professional Development
    • Sponsors: Federal & Non-profits
    • AI/Data/ERA/Systems
    • Finance for Pre-Award
    • Proposal/Research Development
    • Compliance
    • Global
    • PUI

    You can review 2026 program information here.

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    SCOPE Annual Conference

    The SCOPE 2026 website is available and proposals are being accepted!

    Though an official schedule isn’t posted, the event brochure highlights the following educational tracks:

    • Trial design and protocol development
    • Feasibility and site selection
    • Recruitment and engagement

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    SRAI Annual Conferences

    SRAI provides research administrators globally with the knowledge, resources, and community they need to excel, collaborate, and drive impactful research.

    Directly from the website, this organization is the only research management society in the world whose membership spans the entire spectrum of research institutions, including:

    • For-profit entities involved in research and development
    • Public and private colleges and universities
    • Research hospitals and institutes
    • Charitable and research-focused nonprofits
    • Federal, state, and local government bodies engaged in research

    Annual Meeting

    Folks who attend the SRAI 2026 conference will gain fresh perspectives on timely topics from the world’s leading research administration experts.

    Educational tracks include:

    • Financial and Post-Award Administration
    • Management and Operations
    • Professional Development
    • Research Impact and Communications
    • Research Ethics and Compliance
    • Research Law and Regulations
    • Sponsors and Agencies
    • Sponsored Programs Planning, Development and Deliveries
    • Technology Solutions in Research Administration

    Financial Management Conference

    The Financial Management Conference is a virtual professional development event focused on financial and post-award management in research administration.

    This year’s tracks include:

    • Grant accounting
    • Departmental administration finance
    • Non-financial post-award
    • Financial leadership
    • Advance finance topics

    Research Administration Conference

    The Research Administration Conference offers one yearโ€™s worth of online training in three days, with the flexibility to create your own schedule.

    This year’s tracks include:

    • Professional development
    • Pre-award
    • Contract and law
    • Compliance and ethics
    • Financial and cost accounting

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    I hope you found this article informative!

  • Critical Clinical Trial Documents under ICH GCP E6(R3)

    Critical Clinical Trial Documents under ICH GCP E6(R3)

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Eager to skip ahead to today’s topic?

    Jump to the Table of Contents.

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    330+ subscribers and counting!

    Authored By: Tasha Mohseni

    I’d like to dedicate today’s article to those who have served our country!

    Your sacrifices for our freedom can never be repaid.

    If any of my subscribers are veterans, please know that I recognize your patriotism, courage, and contributions. Regardless of the branch of military you serve, we see you. We may be honoring you today, but we keep you in our hearts forever. I know I always keep those family members of mine who have served in my heart daily.

    american flag on brown grass field
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    For today’s post, we are going to do further exploration on an ethical guideline.

    We will explore which documents are critical for clinical trials:

    • I will use ChatGPT to see what is considered a clinical trial document.
    • I will compare the ICH GCP E6(R3) document with ChatGPT’s analysis.

    As a general reminder, any legal information discussed within this post should be discussed with your institution.

    Table of Contents:

    Learning about critical clinical trial documents from ChatGPT

    As you may recall, I have a personal ChatGPT-4 account that I have used for various posts.

    Via the iterative prompting process, I’m going to share how I learned about critical documents in a clinical trial.

    Prompt 1: “What are critical documents in clinical trials?”

    ChatGPT provided the following response below:

    Critical documents in clinical trials are essential records required to ensure that a trial is conducted in compliance with Good Clinical Practice (GCP) and applicable regulatory requirements. These documents enable the evaluation of the conduct of the trial and the quality of the data produced. According to ICH E6(R2) GCP guidelines, critical documents should be maintained throughout the trial life cycle and are grouped into three categories:

    • Before the Clinical Trial Begins
    • During the Clinical Trial
    • After Completion or Termination
    ChatGPT has broken down the ICH GCP E6(R2) critical clinical trial documents into three phases: before, during, and after a clinical trial (or termination of a clinical trial). Each phase has a description of the type of documents present as well as a list of these documents.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    The purpose of these critical documents is to:

    • Ensure participant safety
    • Verify data integrity
    • Provide a trail for regulatory inspections
    • Support reproducibility and transparency

    Though this sounds like great information, I noticed one critical component.

    The above response is in accordance with ICH GCP E6(R2) guidelines.

    There are new guidelines that were adopted in January 2025: ICH GCP E6(R3).

    (Back to the Contents)

    Prompt 2: “What about in the ICH E6(R3) guidelines?“

    ChatGPT provided the following response below:

    Great question. The upcoming ICH E6(R3) Good Clinical Practice (GCP) guideline builds on the principles of ICH E6(R2) but takes a more flexible, risk-based, and modern approach to clinical trial documentation and conduct. While the core concept of critical documents remains, ICH E6(R3) shifts focus toward quality by design, fit-for-purpose documentation, and proportionality in managing trial records.

    What Are “Critical Documents” in ICH E6(R3)?
    ICH E6(R3) does not list a fixed inventory of critical documents (like R2 did with its Essential Documents list in Section 8). Instead, it emphasizes, Fit-for-purpose documentation:

    • Documentation should be proportional to the risk and complexity of the trial.
    • Only documents necessary to reconstruct and evaluate the trial are considered critical.
    • Sponsors and investigators are expected to identify which documents are critical for data reliability and participant protection.

    Key Shifts in R3 Regarding Documentation:

    There are three key shifts with respect to clinical trial documentation per the ICH GCP E6(R3): principle-based approach, quality management integration, and technology considerations. Each shift is described within this image.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    Instead of a fixed list, the types of documents likely to be considered critical still include:

    These examples of ICH GCP E6(R3) critical clinical trial documents fall under six categories: trial design, oversight & approval, participant safety, data integrity, accountability, and closure.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    Summary of Differences: ICH E6(R2) vs. R3 Table:

    AspectE6(R2)E6(R3)
    Document listFixed list of essential documents (Section 8)No fixed list; context-dependent
    FlexibilityLess flexibleMore flexible, risk-based
    EmphasisComplianceQuality-by-design
    TechnologyLimitedEmbraces digital systems, decentralized trials
    As stated within the table’s title, this table compares various aspects of documentation with respect to ICH GCP E6(R2) and ICH GCP E6(R3).

    Though I felt like I was getting closer to what I was looking for, I wasn’t quite there yet.

    (Back to the Contents)

    Prompt 3: “For Examples of Critical Documents under ICH E6(R3) can you define these in a bulleted list?”

    ChatGPT provided the following response below:

    Absolutely! Here’s a bulleted list of examples of critical documents under ICH E6(R3), grouped by functional area. These reflect the risk-based, flexible approach of R3 while aligning with essential GCP principles:

    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to trial design and planning. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to oversight and ethical approval. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to participant safety and rights. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to data collection and integrity. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to investigational product management. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to trial oversight and conduct. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).


    These are examples of ICH GCP E6(R3) critical clinical trial documents with respect to trial closure and reporting. Examples of these documents along with their definitions are provided.

    Please note this is a CREST graphic created via Google Slides (i.e., not ChatGPT).

    (Back to the Contents)

    Reviewing the ICH GCP E6(R3) guidelines

    Now that I have a list to refer to from ChatGPT, it’s time to review the guidelines themselves!

    What is Good Clinical Practice (GCP)?

    “Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the
    conduct of trials that involve human participants.”

    The above is a direct quote from the ICH GCP E6(R3) guidelines. A few other bullet points worth mentioning are listed below:

    • The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
    • This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies which includes:
      • Fostering a quality culture and proactively designing quality into clinical trials and drug development planning,
      • Identifying factors critical to trial quality, engaging interested parties, as appropriate, and
      • Using a proportionate risk-based approach

    Please note that it is not within the scope of this blog to discuss the guidelines in its entirety.

    (Back to the Contents)

    Jumping to Appendix C within the ICH GCP E6(R3) guidelines

    Appendix C includes essential records for the conduct of a clinical trial.

    Though this is not an exhaustive list, I wanted to make note of the following with Appendix C:

    • The essential records permit and contribute to the evaluation of the conduct of a trial in relation to the compliance of the investigator and sponsor with Good Clinical Practice (GCP) and applicable regulatory requirements and the reliability of the results produced
    • These records are used by the sponsorโ€™s independent audit function and during inspections by regulatory authority(ies) to assess the trial conduct and the reliability of the trial results
    • Certain essential records may also be reviewed by the institutional review board/independent ethics committee (IRB/IEC) in accordance with applicable regulatory requirements
    • These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their respective records
    • Certain essential records may not be specific to a trial but may be related to the investigational product, facilities or processes and systems, including computerized systems, involved in running multiple trials and retained outside the trial-specific repositories such as:
      • Investigatorโ€™s Brochure
      • Master services agreements
      • Standard operating procedures
      • Validation records

    “The assessment of whether a record is essential and has to be retained should take into account the criteria below.”

    As stated within the guidelines, an essential record:

    • Is a document that is submitted to or issued by the regulatory authority or IRB/IEC, including related correspondence and those documenting regulatory decisions or approvals/favorable opinions;
    • Is a trial-specific procedure or plan;
    • Is relevant correspondence or documentation of meetings related to important discussions and/or trial-related decisions that have been made related to the conduct of the trial and the processes being used;
    • Documents the conduct of relevant trial procedures (e.g., database lock checklist produced from following data management standard operating procedures (SOPs));
    • Documents the arrangements between parties and insurance/indemnity arrangements;
    • Documents the compliance with the requirements and any conditions of approval from the regulatory authority or the favorable opinion of the IRB/IEC;
    • Documents the composition and, where appropriate, the functions, correspondence and decisions of any committees involved in the trial approval or its conduct;
    • Demonstrates that a trial-specific computerized system is validated and that non-trial-specific systems (e.g., clinical practice computerized systems) have been assessed as fit for purpose for their intended use in the trial;
    • Is a document that has been authorized/signed by the sponsor and/or investigator to confirm review or approval;
    • Is, where necessary, documentation that demonstrates signatures/initials of staff undertaking significant trial-related activities; for example, completing data acquisition tools;
    • Documents what information was provided to potential trial participants and that participantsโ€™ informed consent was appropriately obtained and maintained;
    • Documents that sponsor personnel involved in the trial conduct and individuals performing significant trial-related activities on their behalf are qualified by education, training and experience to undertake their activities;
    • Documents that the investigator and those individuals delegated significant trial-related activities by the investigator are qualified by education, training and experience to undertake their activities, particularly where the activities are not part of their normal role;
    • Contains the data as well as relevant metadata that would be needed to allow the appropriate evaluation of the conduct of the trial;
    • Is a document related to the sponsor or investigator oversight of trial participant safety during the trial, including compliance with safety reporting requirements between sponsors and investigators, regulatory authorities and IRBs/IECs and informing trial participants of safety information as necessary;
    • Documents that service providers are suitably qualified for conducting their delegated or transferred activities;
    • Documents that laboratory activities and other tests used in the trial are fit for purpose;
    • Documents sponsor oversight of investigator site selection and monitoring and audit of the trial, where appropriate, and provides information on arising issues/noncompliance and deviations detected and implementation of corrective and preventative actions;
    • Documents the compliance with the protocol and/or procedures for management and statistical analysis of the data and production of any interim report and the final report;
    • Documents the collection, chain of custody, processing, analysis and retention or destruction of biological samples;
    • Provides relevant information on the investigational product and its labeling;
    • Provides information about the shipment, storage, packaging, dispensing, randomization and blinding of the investigational product;
    • Provides, where appropriate, traceability and accountability information about the investigational product from release from the manufacturer to dispensation, administration to trial participants, return and destruction or alternative disposition;
    • Provides information on the identity and quality of the investigational product used in the trial;
    • Documents processes and activities relating to unblinding;
    • Documents the recruitment, pre-trial screening and consenting process of trial participants and their identity and chronological enrollment as appropriate;
    • Documents the existence of the trial participants and substantiates the integrity of trial data collected. Includes source records related to the trial and medical treatments and history of the trial participants;
    • Defines processes/practices in place in the event of a security breach in order to protect participantsโ€™ rights, safety and well-being and the integrity of the data

    (Back to the Contents)

    Comparing essential ICH GCP E6(R3) records to ChatGPT critical clinical trial documents

    For ease of comparison, let’s review the essential records table from ICH GCP E6(R3) to ChatGPT’s critical clinical trial documents!

    I decided that a Google spreadsheet would be the best way to do this comparison. You can view and download the spreadsheet here: CT Document Table Comparison.

    Upon review:

    • ChatGPT only stated 26 clinical trial documents while the ICH guidelines stated 55 essential documents.
      • Please note that though there are 59 rows within the spreadsheet, three of the rows are grouped (rows 18-21).
    • In yellow, I highlighted documents that ChatGPT mentioned which appeared to be a direct match to the ICH guidelines.
      • 12 clinical trial documents were highlighted.
    • In orange, I highlighted documents that ChatGPT mentioned which appeared to be a partial match to the ICH guidelines.
      • Six clinical trial documents were highlighted.
    • Eight documents remained white (i.e., no color highlight) from the ChatGPT column.
      • These documents didn’t appear to match any of the essential records from the ICH guidelines column.

    Though ChatGPT gave me a starting point, I wouldn’t solely rely on this for learning purposes.

    You really need that specialized expertise to help get you started.

    (Back to the Contents)

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    I hope you found this post educational and useful!

  • Savini Consulting: QA/QI Automation for Post Approval Monitoring (A-PRAISE)

    Savini Consulting: QA/QI Automation for Post Approval Monitoring (A-PRAISE)

    Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

    Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

    300+ subscribers and counting!

    It’s amazing where life can take you.

    • First, I’m writing about helpful career hacks and insights.
    • Next, I’m providing regulatory news and sharing recent developments within the research administration and compliance fields.
    • From solo posts to featuring subscribers skilled in their craft.
    • As well as leading voices that cultivate research integrity.

    Which leads me to my next point…

    I had the pleasure of speaking to Cheryl Savini, President and Founder of Savini Consulting, LLC.

    During our session, I had a demo of her team’s powerful (and impressive) tool, A-PRAISE.

    For today’s post, I will be sharing why A-PRAISE will boost your HRRP/IRB administrative processes.

    Think of A-PRAISE as your secret weapon in automating the post approval monitoring process.

    As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution or organization.

    Let’s learn A-PRAISE:

    What is A-PRAISE?

    A-PRAISE stands for “Automated Program for Research Administration, Integrity, Stewardship, and Education”.

    This multi-purpose tool aids, optimizes, and simplifies for research portfolio management and quality assurance processes.

    • Have you ever wondered how many NIH grants are in your current portfolio?
    • How about the nature of your IRB studies (e.g., the number of studies that are exempt or include special populations)?
    • How about which IRB studies to review for audit?

    If you’re unable to answer these questions via your current systems or procedures, you can count on A-PRAISE. This tool is the solution you never knew you needed. A-PRAISE can enhance quality improvement initiatives within your HRPP/IRB programs.

    Why do I love A-PRAISE?

    Allow me to share my top five reasons why I am a HUGE FAN of this product!

    • A-PRAISE is smart.
      • A-PRAISE only requires source data to work its magic. You don’t have to worry about multiple spreadsheets or manual data entry.
    • A-PRAISE is not only a tool, but a teacher.
      • Remember when I asked earlier how you would conduct an audit of your IRB studies? Maybe this is your first time performing post approval monitoring and you have no clue where to begin. A-PRAISE provides actionable step-by-step processes on how to conduct various audits. Not only are steps provided, but a schedule of when these steps should be completed.
    • A-PRAISE is holistic.
      • A-PRAISE touches all steps within the post approval monitoring process without the need for additional staff. If you’re a “one-man show”, your worries are over. From push button reports to email generation, A-PRAISE automates tedious workflows. With A-PRAISE, you are in control of your time.
    • A-PRAISE provides actionable recommendations.
      • A-PRAISE conducts a gap analysis your HRPP/IRB program should address to enhance quality. Quality improvement activities could be the creation of training documents or revamping PI forms.
    • A-PRAISE is completely customizable.
      • From dashboards to reports to metrics, A-PRAISE can be tailored to the needs of your program. Needs are variable and change over time. A-PRAISE is proactive and can keep up with changes based on what your program wants to see.

    Who can benefit from A-PRAISE?

    Though many folks can benefit from A-PRAISE, I immediately thought of two particular groups.

    My first thought was for small HRPP/IRB offices or those programs that are currently experiencing staff shortages.

    • Another thought I had were programs who haven’t performed post approval monitoring.

    Again, A-PRAISE can teach you about auditing and provide recommendations to further enhance the quality of your daily operations.

    Why do we need A-PRAISE?

    In an influential LinkedIn post by former OHRP Director, Dr. Molly Klote, we were reminded of the importance of proactive post-approval monitoring. You can review the full letter, but I’d like to highlight a critical aspect directly quoted from the letter:

    • “Initial IRB review and continuing review are crucial gatekeepers, but the true test of our commitment to human subjects lies in our ongoing oversight of research as it is conducted. We must move beyond a reactive stance and only investigator reporting and embrace a culture of continuous monitoring to ensure that approved protocols are executed ethically and in accordance with the approved protocol and regulatory standards. Post approval compliance monitoring should not be used to punish but to educate. We must invest in ongoing education.”

    As someone who believes in promoting education and trust within the research and compliance community, this resonated with me. In these times, it’s essential to work smarter not harder. Professionals in this realm must be able to adapt quickly to overcome adversity.

    A-PRAISE can be your program’s saving grace.

    I hope this post gave you something to think about for your HRPP/IRB operations! There will not be a poll for this post, but readers are strongly encouraged to leave comments. I’d love to know what you think about this product and how your program can benefit.