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Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, Cleaning Validation, or Drug Safety.
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Searching courses for: Clinical Trials
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Regulatory Affairs for Clinical Research (US & EU) Professional Certification ProgramRegulatory Affairs for Clinical Research (US & EU) Professional Certification ProgramAdvance your career in regulatory affairs with our 'Regulatory Affairs for Clinical Research (US & EU) Professional … Course ID: GCP00A2 |
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Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationStreamline your path to multi-country trial approval with a single electronic application. This course demystifies the EU Clinical Trials Regulation, helping you gain authorization across the EEA effi … Course ID: CT11 |
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Clinical Trial Safety Reporting Requirements in the EU and USADeepen your expertise in safety reporting by learning the legal and regulatory frameworks governing clinical trials in the EU and USA. This advanced course builds on CT13 and delivers jurisdiction-spe … Course ID: CT14 |
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Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EUNavigate the EU's regulatory landscape with confidence. This course teaches you how to secure both regulatory and ethics committee approval for your clinical trials within the European Economic Area.C … Course ID: GCP020 |
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Clinical Trials Management (US & EU) Professional Certification ProgramClinical Trials Management (US & EU) Professional Certification – Advance Students Career in Clinical Research, Regulatory Affairs, and Trial OversightStep into a leadership role in clinical research … Course ID: GCP00A1 |
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Clinical Trials: Preparation and DesignSuccess in drug development begins with smart planning. This course guides you through designing and preparing clinical trials that deliver reliable, high-quality data while keeping costs under contro … Course ID: GCP002 |
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GCP: ICH-GCP Good Clinical Practice E6(R3)Step into the world of clinical research excellence with our updated ICH-GCP E6(R3) course – the gold standard for ethical, scientific, and quality practices in clinical trials. Gain insider knowledge … Course ID: GCP001 |
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Clinical Trials in Drug Development (Fundamentals)Discover the pivotal role clinical trials play in transforming innovative drug concepts into market-ready therapies. This foundational course provides an essential understanding of how clinical trials … Course ID: CT04A |
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Good Clinical Practice Training (GCP): ICH E6(R3)Training Program: Good Clinical Practice (GCP) Training – ICH E6(R3)Stay ahead in the fast-evolving world of clinical research with our comprehensive GCP Training, fully aligned with the latest ICH E6 … Course ID: CP022a |
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Safety Reporting in Clinical Trials (Adverse Event Reporting)Confidently navigate the complex regulatory landscape of adverse event reporting in clinical trials. This course breaks down responsibilities for investigators and sponsors, and clarifies key terminol … Course ID: CT13 |
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Clinical Research Associate (CRA) Professional Certification ProgramClinical Research Associate (CRA) Professional Certification Program – Master the Skills to Oversee and Ensure the Success of Clinical TrialsStep into one of the most in-demand roles in clinical resea … Course ID: GCP00A |
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GCP Refresher Training: ICH E6(R3)Training Program: GCP Refresher Training: ICH E6(R3)Stay ahead in the fast-evolving world of clinical research with our GCP Refresher Training, fully aligned with the latest ICH E6(R3) revisions. This … Course ID: CP024a |
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GCP: ICH, Harmonization, and Principles of GCP ICH E6(R3)Step into the world of international clinical research with the confidence to meet-and exceed-global standards. This dynamic course gives you the knowledge to navigate one of the most heavily regulate … Course ID: CT03A |
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Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials RegulationOnce your trial is approved, maintaining compliance is critical. This course provides the operational know-how to conduct EU-authorized trials successfully.Manage sponsor responsibilities throughout t … Course ID: CT12 |
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Clinical Trials and Drug DevelopmentDiscover how clinical trials fit into the bigger picture of drug development, from concept to market. This course blends history, regulation, and modern-day cost-control measures to give you a compreh … Course ID: GCP003 |
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Overview of ICH E8(R1): General Considerations for Clinical Studies GuidelineICH E8(R1) is the umbrella guideline connecting the entire ICH "E" family, including Good Clinical Practice (ICH E6). This revision modernizes how clinical trials are designed, planned, managed, condu … Course ID: CP019a |
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Clinical Research Coordinator (CRC) Professional Certification ProgramTake your clinical research career to the next level with the Clinical Research Coordinator (CRC) Professional Certification Program. This comprehensive, six-course program equips students with the es … Course ID: CRCPRO |
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Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)Stay ahead of evolving EU regulatory requirements with this course covering the transition from the EU Clinical Trials Directive to the Clinical Trials Regulation (EU CTR 536/2014). Learn how to plan, … Course ID: CP018a |
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The General Data Protection Regulation (GDPR) and Clinical TrialsMaster the complexities of data protection in global clinical trials with this GDPR training. Learn how to lawfully exchange and process personal data between the EU and the U.S. while safeguarding pa … Course ID: CP009a |
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HIPAA Training for Clinical Trial ProfessionalsProtect patient privacy while running compliant clinical trials in the United States with this targeted HIPAA training. Designed for sites, sponsors, and CROs, this course provides best practices for … Course ID: CP017a |
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Clinical Trials: Preparation (Fundamentals)Transform your trial preparation skills and ensure every study starts on the right track! This course guides you through the essential steps for setting up a clinical trial, from regulatory documentat … Course ID: CT04C |
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GCP: Clinical Research Teamwork (Fundamentals)Updated to ICH GCP E6(R3) guidelines, this course empowers learners to master effective teamwork in clinical research. Clinical trials-especially large, late-phase studies-require seamless collaborati … Course ID: CT03B |
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Good Clinical Laboratory Practice (GCLP)Ensure your clinical trial laboratory data is accurate, reliable, and respected worldwide. Good Clinical Laboratory Practice (GCLP) combines the rigor of GLP and GCP to set the standard for labs analy … Course ID: GLP03 |
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Clinical Trials: Protocol Design (Fundamentals)Step into the critical world of clinical trial protocol design-where strategy meets science! This course empowers clinical research professionals to create protocols that are scientifically sound, eth … Course ID: CT04B |
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ISO 14155:2020 Medical Device StandardMaster the global gold standard for medical device clinical trials with this detailed course on ISO 14155:2020. Learn how to integrate Good Clinical Practice (GCP) into every stage of a medical device … Course ID: CP008a |
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Clinical Trials: Statistical Elements (Fundamentals)Statistics are the backbone of trial credibility-this course ensures you understand and apply them effectively! Learn key statistical concepts that enhance the design, conduct, and interpretation of c … Course ID: CT04E |
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Investigator Initiated Clinical TrialsDiscover the unique responsibilities of investigator-initiated trials (IITs) and how they differ from sponsor-led studies. Learn what it means to be both the investigator and sponsor, and the regulati … Course ID: CP011a |
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Clinical Trial Monitoring: Documentation and ClosureFrom start to finish, proper monitoring ensures trial success. This course teaches how to protect subject welfare, ensure data accuracy, and comply with GCP and regulatory requirements – all the way t … Course ID: GCP005 |
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Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsTake your investigational drug from the lab to the clinic by mastering the FDA's IND process. This course provides the tools you need to prepare and submit a complete, compliant application.Learn the … Course ID: GCP007 |
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GCP: Clinical Trial Monitors GCP ICH E6(R3) Responsibilities (Fundamentals)Updated to ICH GCP E6(R3), this course equips monitors with modern strategies for ensuring trial quality-from traditional site visits to centralized and remote monitoring approaches.Learn the monitor' … Course ID: CT03G |
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Clinical Trials: Study Design (Fundamentals)Study design determines trial success-learn to choose the right path! This course covers the main types of clinical trial designs, from randomized controlled trials to observational studies, helping y … Course ID: CT04F |
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Clinical Trial eSystems Inspection ReadinessPrepare your organization for regulatory inspections by mastering compliance with FDA 21 CFR Part 11 for electronic systems in clinical trials. Learn how to validate, secure, and oversee systems used … Course ID: CP021a |
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GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities (Fundamentals)Updated to ICH GCP E6(R3), this course gives sponsors a deep dive into their responsibilities-from trial initiation and management to financing and oversight. The latest revision outlines new expectat … Course ID: CT03D |
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GCP: Informed Consent in Clinical Trials (Fundamentals)This course covers the ethical and regulatory foundation of informed consent-ensuring participants voluntarily join trials with full understanding of risks, benefits, and their rights.Master ICH GCP e … Course ID: CT03F |
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Clinical Trials: Endpoints (Fundamentals)Endpoints define the story your trial will tell-make sure it's a compelling one! This course deep-dives into selecting, defining, and managing primary, secondary, and exploratory endpoints that meet r … Course ID: CT04D |
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Clinical Trials: Data Capture (Fundamentals)Data is the lifeblood of clinical research-learn to capture it with accuracy, efficiency, and compliance! This course explores best practices for data collection and management, ensuring your trial da … Course ID: CT04G |
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GCP: Clinical Trial Investigators GCP ICH E6(R3) Responsibilities (Fundamentals)Updated to ICH GCP E6(R3), this course is tailored for investigators-the individuals responsible for participant care and trial conduct. You'll explore every GCP duty, from delegating tasks to managin … Course ID: CT03E |
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Assuring Data Integrity in Clinical ResearchProtect your clinical trial credibility by ensuring data is complete, consistent, and accurate. This course details how trial sponsors, investigators, and research staff can meet data integrity requir … Course ID: ICT03 |
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GCP: Clinical Trial GCP ICH E6(R3) Records and Data Governance (Fundamentals)Updated to ICH GCP E6(R3), this course teaches the critical role of rigorous documentation in proving compliance and ensuring trial integrity. With regulators following the maxim "If it isn't document … Course ID: CT03C |
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Clinical Trial Monitoring: Site Evaluation and Set-upEnsure your clinical trial starts on the right foot with expert knowledge on site selection and preparation. This module, updated for ICH E6(R3), covers the essential steps in evaluating investigators … Course ID: GCP004 |
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Clinical Trials: Preparing for an Audit or InspectionAudits and inspections don't have to be stressful – if you're prepared. This course equips you to meet US FDA and European regulatory expectations with confidence.Understand the scope and purpose of G … Course ID: GCP006 |
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DIGR-ACT® Solution: Critical Thinking Skills – Including Root Cause Analysis & CAPADIGR-ACT® is a game-changing solution that equips clinical research professionals with the critical thinking skills needed to prevent and manage issues effectively. With the explosion of available … Course ID: CP001a |
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GCP Training: ICH E6(R2)This comprehensive GCP training covers the essentials of ICH E6(R2) for clinical trials, including investigator, sponsor, and stakeholder responsibilities. You'll explore major regulatory agencies, es … Course ID: CP002a |
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ICH E6(R2) GCP Training for Investigator Site Personnel (Investigators and CRCs)Specially designed for investigator site teams, this course covers the GCP essentials in ICH E6(R2) with a focus on the role of the investigator, clinical research coordinators, and other site personn … Course ID: CP004a |
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Corrective and Preventive Action (CAPA) Process Planning for Clinical Research ProfessionalsBuild a strong CAPA foundation to manage and resolve significant noncompliance in clinical research. This course equips sponsors, CROs, and sites with the knowledge to develop and implement effective … Course ID: CP006a |
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Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IECBuild a strong foundation in protecting human subjects during clinical trials with this course on 21 CFR Part 50 and Part 56. Learn the ethical and regulatory requirements that safeguard participants … Course ID: CP014a |
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Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesDive into the specialized world of monoclonal antibody (mAb) regulation. This course addresses unique issues in producing and testing mAbs, covering manufacturing quality, nonclinical, and clinical re … Course ID: PRA05 |
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Critical Thinking for Clinical Research ProfessionalsThis companion to the DIGR-ACT® Solution builds your ability to think critically in clinical trial environments. You'll learn to identify the issues that truly matter, map information to root caus … Course ID: CP020a |
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AI Applications and Quality Management in GxP EnvironmentsAI (artificial intelligence) Applications and Quality Management in GxP Environments is a practical, forward-looking eLearning course designed for professionals working in pharmaceutical, biotechnolog … Course ID: AI-501 |
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Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)Gain mastery over expedited safety reporting in clinical trials with this deep dive into the ICH E2A guideline. Understand key definitions, standards, and procedures that keep safety reporting accurat … Course ID: CP012a |
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Major Changes in GCP from ICH E6(R2) to (R3): Road MapStay ahead of the curve with our in-depth training on the newly revised ICH GCP E6(R3) guidelines. This course dives into the latest changes, integrating key concepts from ICH E8(R1) and emphasizing Q … Course ID: CP023a |
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CRO OversightEnsure your outsourcing partnerships are a success with this comprehensive course on CRO and vendor oversight. Learn the systems and strategies needed to monitor quality, protect study participants, a … Course ID: CP007a |
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Structure and Content of Clinical Study Reports (ICH E3)Learn how to produce professional, regulatory-compliant clinical study reports (CSRs) following the ICH E3 guideline. This course breaks down CSR sections, content requirements, and the 2012 ICH E3 Q& … Course ID: CP013a |
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Introduction to AI Regulatory Compliance Management: The Expert-in-the-Loop (EIL)Artificial intelligence is rapidly transforming the life sciences industry – from pharmaceutical manufacturing and medical devices to clinical research and regulatory operations. As AI, machine learni … |
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Good Pharmacoepidemiology Practice Professional Certification ProgramGood Pharmacoepidemiology Practice (GPP) Professional Certification ProgramMaster the skills to generate and apply real-world drug safety evidence. This comprehensive certification program equips stud … Course ID: AV01B |
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Medical Device vs. Drug: Comparing and ContrastingClarify the regulatory and operational differences between medical device and drug clinical trials. This course breaks down definitions, approval pathways, safety reporting, and global perspectives, w … Course ID: CP010a |
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Drug Safety and Pharmacovigilance Professional Certification ProgramDrug Safety and Pharmacovigilance Professional Certification ProgramProtect public health. Advance your career. Become a certified expert in drug safety and pharmacovigilance.In today's highly regulat … Course ID: AV01 |
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GCP Refresher Training for the Experienced ProfessionalRefresh and sharpen your GCP expertise with this advanced-level course designed for experienced clinical research professionals. This program revisits the critical requirements of ICH E6(R2) GCP while … Course ID: CP003a |
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Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)Demystify the IND and NDA process with this comprehensive course on 21 CFR Part 312 and Part 314. Understand the legal, regulatory, and operational requirements to get your investigational product fro … Course ID: CP015a |
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Pharmacokinetics and Pharmacodynamics for ProfessionalsPharmacokinetics and Pharmacodynamics for ProfessionalsMaster the science that powers modern drug development. This specialized program provides a comprehensive, practical understanding of Pharmacokin … Course ID: AV01A |
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AI Quality Regulatory Compliance Management Professional Certification ProgramThe AI Quality Regulatory Compliance Management Professional Certification Program is designed to prepare life sciences professionals for one of the most important emerging roles in regulated industry … Course ID: AI-201 |
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GxP: Good Practices (GxP) in Drug Development and ManufacturingTake your first step into the regulated world of life sciences with this entry-level GxP course. Understand how the pharmaceutical industry operates, the role of regulatory authorities, and the essent … Course ID: GXP01 |
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Good Documentation Practices and ALCOA-CMaster the art of impeccable documentation with this in-depth course on Good Documentation Practices (GDocP) and the ALCOA-C principles. Learn how proper documentation underpins product quality, safet … Course ID: CP005a |
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Regulatory Affairs: Essentials for Human Medicinal Products – EU and USStart your regulatory affairs journey with a strong foundation in pharmaceutical compliance. This program is ideal for newcomers, offering a comprehensive look at the requirements to gain and maintain … Course ID: PRA01 |
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Drug Safety: Signal Detection and Management in PharmacovigilanceDiscover how to identify, validate, and manage safety signals that protect patients and preserve your product's benefit-risk profile. This course equips you with practical tools and methods – from med … Course ID: PV04 |
