Courses

Our course series on ICH Good Clinical Practice equips trial investigators and clinical researchers with the essential knowledge required to conduct reliable and ethical clinical trials. Whether you are new to the field or an experienced professional, this course series provides the background needed to ensure participant safety, data integrity, and compliance with international regulations.

This specialization is designed for individuals and teams that will be running or interacting with clinical trials. In four courses, learners will develop insights and build the skills they need to design, manage, and monitor clinical trials as well as analyze, document, and communicate the results. Learners will also learn best practices regarding ethics, safety, participant recruitment, regulatory compliance, and reporting standards. The core principles and skills of the specialization will lay the foundation for a successful career in the field.

Learn about breast cancer clinical trials through this 13-minute educational video where Dr. Adrienne G. Waks, associate director of Breast Oncology Clinical Research at Dana-Farber Cancer Institute, provides a patient-friendly overview of what clinical trials are and how they work. Gain essential knowledge about the clinical trial process, understand how these research studies are conducted, and discover what participation might involve for breast cancer patients. Explore the fundamentals of clinical research in oncology, including the structure and phases of trials, patient safety measures, and the role these studies play in advancing breast cancer treatment options.

In today’s increasingly globalized world, ensuring that clinical research reflects the populations it aims to serve is more crucial than ever. This course provides an introduction to representation in clinical trials. Over three weeks, you will learn about why this topic is important in clinical research, common barriers and challenges to participation of underrepresented populations, how conscious and unconscious biases can appear, and the consequences this can have on clinical research. Throughout the course, you’ll hear firsthand insights and perspectives from experts in the field as well as practical guidance and self-reflective activities. This course is aimed at clinical trial investigators, sites, and teams, as well as anybody who would like a better understanding of how to strengthen and broaden outreach when recruiting representative populations in clinical research.

Explore how artificial intelligence is revolutionizing clinical trials through this 13-minute conference talk from Conf42 Cloud Native 2025. Discover AI applications in statistical programming and learn how automation enhances efficiency across clinical trial processes. Understand how AI improves patient recruitment strategies and enables more effective safety signal detection and risk management. Examine real-time monitoring capabilities and predictive modeling techniques that transform data extraction and processing workflows. Learn about maintaining data integrity and compliance standards while leveraging AI for optimized site monitoring. Investigate AI's role in regulatory documentation and submission processes, and explore advanced algorithms specifically designed for clinical trial environments. Gain insights into AI-powered decision support systems and risk detection mechanisms. Understand strategic approaches for integrating AI technologies into existing clinical trial frameworks and explore future possibilities for AI in clinical research and biotech analysis.

Mastering Statistical Design and Analysis for Clinical Trial Validity What you'll learn: Understand the basic concepts of biostatistics relevant to clinical trials.Learn the statistical methods used in the design and analysis of clinical trials.Interpret statistical results correctly to make informed decisions.Gain insights into the regulatory aspects of statistical analysis in clinical research.Develop the ability to critically assess the statistical quality of clinical trial reports. The “Statistics in Clinical Trials” course offers a comprehensive exploration of the statistical methods essential for clinical trial design, analysis, and interpretation, targeting professionals in clinical research who aim to enhance their analytical skills. This course covers foundational statistical principles, from basic descriptive statistics to advanced methods, providing participants with tools to ensure the validity and reliability of trial data. The curriculum spans 20 one-hour topics, blending theoretical understanding with practical applications, allowing participants to develop a robust statistical skill set tailored to clinical research needs. The course begins with an overview of clinical trials and statistical concepts, setting the stage for deeper exploration of study design and the importance of methodological rigor. Early modules introduce key elements of clinical trial design, such as sample size calculation and randomization methods, which are critical for minimizing bias and ensuring trial validity. Participants will also learn about data management processes, including data collection, cleaning, and validation using tools like Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems. Moving into statistical analysis, participants explore descriptive statistics (measures of central tendency and dispersion) to summarize baseline characteristics and create graphical data representations, providing a solid foundation for data interpretation. The course also covers hypothesis testing fundamentals, including null and alternative hypotheses, Type I and Type II errors, and significance levels, ensuring that participants understand the role of statistical testing in clinical decision-making. Building on these basics, the curriculum progresses into advanced topics like t-tests, ANOVA, Chi-square, and Fisher’s Exact tests for comparing means and analyzing categorical data. These methods are essential for assessing differences across patient groups and treatment outcomes. Further modules delve into correlation and regression analysis, including multiple and logistic regression techniques, which allow participants to evaluate relationships between variables and predict treatment effects. The course also addresses specialized topics such as survival analysis, covering Kaplan-Meier estimates, log-rank tests, and Cox proportional hazards models, which are particularly relevant in trials involving time-to-event outcomes. For studies with repeated measurements or longitudinal data, participants learn about mixed-effects models and Generalized Estimating Equations (GEE) to analyze data across multiple time points effectively. Additional topics include non-parametric methods for non-normal data, approaches for managing multiplicity and conducting interim analyses, and the design of equivalence and non-inferiority trials. Advanced methods such as Bayesian analysis and meta-analysis are introduced, offering participants alternative frameworks for trial design and evidence synthesis across studies. The course concludes with practical guidance on reporting clinical trial results according to CONSORT guidelines, ensuring that participants can accurately and transparently present statistical findings. By covering a broad range of topics, this course equips clinical research professionals with the expertise needed to apply statistical methodologies confidently, supporting the design of scientifically rigorous trials that inform regulatory decisions and contribute to advancements in patient care.

Master clinical trial phases, ICH-GCP, key roles & protocol design—plus AI, RWE, and patient-centric innovations. What you'll learn: New Update (August-2025): Landing a Job in Clinical Research: CV, Interview, LinkedIn & Career TipsDesigned like top university programs—practical, structured, and podcast-style for real-world clinical research success.Define the roles and responsibilities of sponsors, CROs, CRAs, and site staff in clinical trials.Learn clinical research in podcast style — flexible, clear, and career-focused.Build a career roadmap and prepare for roles like CTA, CRA, CDM, and Clinical Project Manager.Bunes1: How to use EDC SystemBunes2: What's the Data Management Plan(DMP)Navigate all phases of a clinical trial, from study start-up through close-out and post-marketing.Busy schedule? No problem. Learn anywhere with our podcast-style format.Design and interpret clinical trial protocols, case report forms, and informed consent documents.Identify, document, and report Serious Adverse Events (SAEs) and apply pharmacovigilance practices.Apply digital tools, AI, and remote technologies in decentralized and modern clinical trial models.Evaluate real-world data (RWD) and real-world evidence (RWE) for regulatory and scientific decisions.Develop inclusive, patient-centric trial strategies that enhance recruitment and retention.Gain leadership insights to manage clinical operations and stakeholders strategically.Pair this course with our best-selling CDM course: link below:https://www.udemy.com/course/a-deep-dive-into-clinical-data-management-basics-to-advance/?referralCode=171061DA95F06F098379Create and manage Trial Master File (TMF) components with audit readiness and regulatory compliance in mind.Understand stakeholder alignment across sites, CROs, sponsors, and regulatory bodies.Apply risk-based monitoring and quality management techniques throughout clinical trials.Explore post-market safety surveillance and the role of Phase IV studies in long-term data collection.Clinical trials made simple — step-by-step, audio-first, and job-ready.Build your research career with engaging audio lessons and practical tools.Clinical research made modern — learn by listening, grow by doing. A Deep Dive into Clinical Research: Step-by-Step CertificateMaster trial phases, protocols, ethics, pharmacovigilance, and data operations in clinical research—step by step.Designed like top university programs—practical, structured, and podcast-style for real-world clinical research success. Whether you're a nurse, pharmacist, medical graduate, biologist, or life science student looking to break into clinical trials, this course is built for you.This comprehensive certificate program takes you through every essential part of the clinical trial process—from the foundational principles of Good Clinical Practice (GCP) to the execution of complex global studies. We’ll guide you through the roles of sponsors, CROs, CRAs, data managers, and regulators, while showing you how to design protocols, handle adverse events, and manage clinical data accurately.Why Enroll?Structured and practical, aligned with real-world clinical operationsPodcast-style delivery—perfect for flexible learningIncludes modern trends like AI applications in research and RWE integrationCertificate of completion for professional growthPodcast-style delivery for flexible, learner-friendly accessBuilt to meet Udemy Business quality and relevance standards What You’ll LearnClinical trial phases (I–IV) and their objectivesStudy protocols, regulatory compliance, and ICH-GCPRoles of Sponsors, CROs, CRAs, CRCs, and Regulatory AuthoritiesSerious Adverse Event (SAE) reporting and pharmacovigilanceDigital health tools, AI in trial optimization, and Real-World Evidence (RWE)Patient-centric trial design and future-ready methodologies You’ll also gain leadership insight, resume tools, and access to our downloadable resource kit to accelerate your career in clinical research.Already enrolled in our best-selling Clinical Data Management course? This is the perfect companion. Explore the CDM course

In this 1 hour 17 minute inaugural lecture, Professor Otavio Berwanger, Executive Director for The George Institute for Global Health and Chair in Clinical Trials at Imperial College London, explores innovative clinical trial designs, patient-centered approaches, and the integration of digital technologies that are transforming healthcare research. Discover how modern clinical trial methodologies are evolving to become more efficient and effective while maintaining scientific rigor. Learn about emerging models that prioritize patient experiences and leverage technological advances to accelerate medical discoveries and improve healthcare outcomes. Part of the #ImperialInaugurals series from Imperial College London.

Complete Certified Course on Implementing and Applying mandatory CTR for EU and non-EU Clinical Research Professionals What you'll learn: Gain an overview of the Clinical Trial Regulation (CTR) to conduct trials in the EUUnderstand why changes to the Directive 2001/20/EC were madeLearn and understand the timeline for CTR introduction and transition periodLearn the essential definitions of terms under the CTRUnderstand how the Clinical Trial Information System (CTIS) is set upUnderstand the submission process of clinical trialsUnderstand the validation, assessment and decisions process of clinical trials under the CTRLearn the process to submit a Substantial Modification of the protocolLearn the process to submit a new Member State in an ongoing studyIdentify the safety and other reporting obligationsGrasp the risks and challenges associated with the CTR in sponsor organizationsPractical exercise: Conduct a risk assessment of a regulatory submission with the CTRPractical exercise: Planning a regulatory submission in line with the CTR Updates:[October 2025]: Lecture 15: Q&A Log updated, Walk in Clinic EMAlink added[November 2024]: Lecture 2: Updated key facts[January 2024]: Lecture 14 - CTIS Training material catalogue updated with latest information[March 2023]: Training document material from EMA updated and lecture 14 updated accordingly; New Q&A document from the CTIS/CTR query management working group attached (lecture 15)---On 31st January 2023, the Clinical Trial Regulation (CTR) 536/2014 came into force in the European Union (EU) and repealed the Clinical Trials Directive 2001/20/EC. With this Regulation, the EU harmonises the procedures for carrying out clinical trials across the EU states and simplifies the clinical trial approval process through a Clinical Trials Information System (CTIS).This course provides clinical research professionals in Sponsor and CROorganizations as well as investigational sites and study staff with an essential understanding of the CTR to help implement and comply with it.The programme highlights the most important of these key requirements and how these are impacting all EU as well as non-EU sponsors conducting clinical trials in the EU.My name is Dr. Vincent Baeyens PhD, Ihave more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma and Biotech settings.Benefits of attending this course include:Gain an overview of the Clinical Trial Regulation (CTR) to conduct trials in the EUUnderstand why changes to the Directive 2001/20/EC were madeLearn and understand the timeline for CTR introduction and transition periodLearn the essential definitions of terms under the CTRUnderstand how the Clinical Trials Information System (CTIS) is set upUnderstand the submission process of clinical trials in the CTISUnderstand the validation, assessment and decisions process of clinical trials under the CTRLearn the process to submit a Substantial Modification of the protocolLearn the process to submit a new Member State in an ongoing studyIdentify the safety and other reporting obligationsGrasp the risks and challenges associated with the CTR in sponsor organizationsPrepare a high-level submission planning under CTRQuizzes and assignments are proposed along your journey to test your knowledge.To facilitate the learning of beginner students, the course has been broken up on purpose in small lectures. If you are a more advanced student, you can increase the speed of lecture to learn the course at your desired pace.Important remark: Please note that this course does not go into the technicalities of the CTIS. References to adequate resources on the topic are provided.Feel free to look at the content of the course to know more and contact me any time if you have any questions!I am looking forward to seeing you inside the course!Sincerely,Vincent

Conclude a comprehensive overview on critically evaluating clinical trials in this final installment of a video series. Explore surrogate and composite endpoints, systematic biases in research, validity, and the distinction between clinical and statistical significance. Access a printable summary of the series through the provided link for further reference. Delve into topics such as conflicts of interest, methodologies, blood pressure measurement techniques, and result interpretation to enhance your ability to apply trial information to patient care.

Learn how to critically evaluate a clinical trial in this comprehensive video tutorial. Explore key concepts such as randomization, controls, blinding, allocation concealment, and proper sample size. Gain insights into analyzing the method section, understanding end points, and distinguishing between intention-to-treat and per-protocol analyses. Examine accurate figures in the results section and learn to interpret the discussion. Access a printable summary for quick reference to enhance your ability to appraise clinical trials and apply the information to patient care.

Learn how to dramatically accelerate the validation process for clinical trial platforms using Databricks and generative AI technology in this 26-minute conference talk. Discover how the traditional three-month validation timeline for 21CFR Part 11 compliance has been reduced to less than a day through automated execution of Installation Qualification (IQ) and Operational Qualification (OQ) scripts. Explore the challenges posed by rapidly evolving clinical trial data sources and new therapeutic modalities that require continuous validation in regulated environments. Understand how Purgo AI's innovative approach leverages generative AI to automate manual validation processes, enabling faster implementation of new ideas and technologies in clinical trials while maintaining strict compliance requirements. Gain insights into the renaissance of clinical trial data management and how modern platforms can support the accelerated pace of medical innovation without compromising regulatory standards.

Master Data Integrity & Compliance in Clinical Trials | Clinical Data Management(CDM), GCP, FDA- Real World Case Studies What you'll learn: New Updates (August-2025): Medical Dictionary 2: WHO Drug Coding: Principles and PracticeNew Updates (July-2025): Medical Dictionary 1: MedDRA Coding: Principles and PracticeNew Updates (June-2025): Randomization in Clinical trial and eCRF design and RTSM (Randomization and Trial Supply Management) in Clinical Data ManagementNew Updates added (MARCH-2025): How to Use R A V E EDC- How to use VEEVA EDC - CCDM Exam Mock Test sample questions (11 Questions)We are using a real timeline from study startup to closeout to show you step by step how clinical data management is executed in real-world scenarios.Understand CDM Roles: Master the responsibilities and daily tasks of a Clinical Data Manager.With this course, you’ll be fully equipped to start and excel in your career in the clinical data management industryLearn how to collect, organize, and manage data using industry-standard tools and processes.Craft Data Management Documents: Learn to create effective plans ensuring data accuracy and compliance.Master the creation of essential documents, including a comprehensive Data Management Plan (DMP).Navigate Regulatory Standards: Master compliance with FDA and EMA guidelines in clinical trials.Utilize CDM Tools: Gain skills in using Electronic Data Capture systems and other modern technologies.Ensure Data Quality and Integrity: Learn techniques for data verification, validation, and audit trails to uphold data quality in clinical research.Understand the critical role of clinical data managers in ensuring the success of clinical trials.Build proficiency in using clinical trial software like EDC systems, and CTMS tools.Develop skills to create, validate, and maintain clinical trial databases with precision.Acquire analytical skills to generate accurate and regulatory-compliant clinical trial reports.You will be familiar with Clinical Trial studies Timeline by focusing on Clinical Data Management activitiesLearn to design and manage Case Report Forms (CRFs) for effective data collection in clinical trials.With sample interview questions, sample resume and listinin majre companies you will familar with hiring structreGet sample interview questions, a resume template, and a list of top companies to understand the hiring structure and processes in the clinical data management Unlock the full potential of clinical data management with "A Comprehensive Guide for Clinical Data Managers." This course is meticulously designed to empower you with the skills and knowledge necessary to ensure data integrity, meet regulatory standards, and drive successful outcomes in clinical trials.Starting with the fundamentals, you’ll learn about the roles and responsibilities of a clinical data manager, including data collection, validation, and storage. We'll explore the critical importance of maintaining data integrity and how it impacts clinical trial results.Progressing through the modules, you'll gain hands-on experience with modern data management tools and technologies. Learn to navigate databases, utilize data coding strategies, and implement effective data monitoring techniques. We’ll also delve into the nuances of regulatory compliance, discussing key guidelines from the FDA, EMA, and other regulatory bodies.Through practical examples and real-world case studies, this course offers deep insights into problem-solving and decision-making in complex scenarios. By the end of this course, you will be equipped to lead data management teams, optimize data processes, and contribute to groundbreaking clinical research.Enroll today to become a proficient clinical data manager capable of transforming clinical data into meaningful insights that uphold the highest standards of quality and ethics in healthcare research.

Explore how successful clinical trials are designed and delivered Randomised controlled trials have a huge impact on society by providing evidence of the effectiveness of healthcare, social care, and public health interventions. On this three-week course from the University of Birmingham, you will be guided through the lifecycle of a trial from conception to publication. Discover the importance of statistics and planning in a clinical trial There are many factors to creating and executing a trial. From formulating a clear research question to regulations and funding, a lot needs to be done before starting a medical trial. You’ll begin this course by looking at the different phases of trials and the steps required to conceptualise, design, and plan a successful trial. Then, you’ll examine the specialist roles involved in every step of the trial process and learn the importance of these individual inputs in the conduct of a successful trial. Understand how to manage and interpret trial findings and data The work isn’t finished once a trial is over; there’s a variety of data points and procedures that need to be managed in order to report on the trial findings. This course will take you through the management processes for trial data and the end of trial procedures that need to be followed. You’ll also look at safety reporting and how randomised control trials are published. Learn from the experts at the University of Birmingham This course has been built by a team of expert research trial staff from the Birmingham Centre for Clinical Trials within Birmingham University. This team will guide you through the entire process for conducting randomised controlled trials and how to report results that can then be used to inform guidelines. This course is designed for new or existing clinical trial staff. It may also be of interest to anyone looking to learn more about the wider randomised controlled trials process.

Welcome to 'Fundamentals of Good Clinical Practice: Recruitment and Trial'! This is the third course in the Clinical Trial GCP series. It is designed to introduce you to the processes, procedures and documentation needed prior, during and after a clinical trial according to Good Clinical Practice (GCP). In Courses One and Two, we explored the foundations of clinical research, including the preparations and documentation needed to begin a trial as well as the role of the investigator, site staff and the IRB/IEC. We conclude our GCP studies with this final course. The course is divided into several modules, each covering specific stages of a clinical trial. The modules include a variety of videos, a fictional case study and interactive quizzes to reinforce your learning. Enroll now and start building a strong foundation in the conduct of clinical research!

Gain valuable insights into the world of clinical trials through this informative webinar featuring Dr. Regina Nuzzo and Dr. Kristin Sainani. Explore real-world case studies to understand the successes, pitfalls, and potential improvements in trial design and execution. Learn essential aspects that every researcher should know to conduct successful clinical trials, enhancing your knowledge in research, healthcare, and medicine.

Explore the critical role of clinical trials in advancing treatments for gynecologic cancers in this informative lecture by Dr. Dorigo from Stanford Women's Cancer Center. Gain insights into why clinical trials are essential for patients and discover the various trials available at Stanford for women's cancers. Learn about the latest developments in gynecologic oncology research and how participation in clinical trials can contribute to improved outcomes for patients with female cancers.

Hone data management skills to advance clinical research – and your career Effective data management in clinical trials is the backbone of credible research. Without it, we risk overlooking impactful discoveries and compromising the integrity of groundbreaking innovations. Hone one of medical research’s most important skills on this two-week, online course from the University of Birmingham. On this comprehensive deep dive of data management, you’ll explore how to handle trial data, from collection to archiving, and the quality processes required along the way. By the end, you’ll be able to design and implement robust data management plans to enhance the accuracy and reliability of your trial results, ultimately strengthening your team’s ability to deliver high-quality, impactful research. Grow as a data manager with critical management skills and data validation techniques On the first week of this course, you’ll lay the foundations for effective data management. Learn to create comprehensive data management plans and discover various validation strategies to ensure data accuracy. Promote quality assurance in clinical data management By the second week of this course, you’ll segue into the role of data collection and quality assurance. You’ll examine various monitoring strategies, including site and central monitoring, to maintain data integrity throughout the trial. You’ll then wrap up this course by understanding end-of-trial processes, including cleaning and archiving data. Learn with the experts at the University of Birmingham The University of Birmingham’s Centre for Clinical Trials is a leading UK institution for clinical trial research. With the help of their experts, who’ve crafted this course to deliver exclusive insights and in-demand skills, you’ll be supported throughout your learning journey. This introductory course is for anyone setting up clinical trials and responsible for ensuring trial data integrity, such as aspiring chief investigators, trial coordinators, managers, data managers, and administrators. No prior knowledge is needed to join.

Learn about the latest clinical trial evidence comparing different diuretic medications for treating heart failure in this 48-minute medical lecture from MonteHeart. Explore updated research findings and data that inform optimal diuretic selection, dosing strategies, and clinical outcomes in heart failure patients. Gain insights into evidence-based approaches for choosing between loop diuretics, thiazides, and combination therapy based on patient characteristics and disease severity.

Watch this 17-minute lightning talk from AWS re:Invent 2024 showcasing Huron's innovative approach to clinical trial document analysis using Amazon Bedrock. Explore how their custom tool automates the extraction of critical information from complex clinical trial documents through over 50 integrated prompts connected to Smartsheet via API. Learn about the system's capability to process multiple documents simultaneously, accurately identifying medical terminology and clinical research language to determine insurance coverage for trial participants. Discover how this automation solution has enhanced the efficiency of Huron's consulting team while improving service delivery accuracy for their clients. Gain insights into practical applications of generative AI in healthcare administration and clinical trial management.