Build a rock-solid foundation in how modern clinical trials are designed, run, governed and kept safe, from molecule to marketing.
one-time · lifetime
Clinical research is the disciplined, ethical and highly regulated process by which new medicines, vaccines, devices and diagnostics are tested in human beings before they can reach patients. Every treatment your doctor prescribes today exists because volunteers took part in carefully controlled studies, and because thousands of professionals ran those studies with rigor and integrity. This flagship foundational program gives you the complete mental map of that world.
Across six structured modules you will learn what clinical research actually is, how a drug travels from a laboratory idea to an approved product, who the key players are, and the ethical and regulatory rules that protect participants. You will then follow a trial through its entire lifecycle, understand how data and documents are captured and controlled, and finish with the science of keeping participants safe through pharmacovigilance.
Written by clinical research subject-matter experts and instructional designers, the course is beginner-friendly but genuinely thorough. It uses plain language, real examples and short quizzes after every module so that you retain what you learn. By the end you will be able to speak the language of clinical research confidently and take the first step toward a career as a Clinical Research Coordinator, Clinical Research Associate, data or safety associate, or regulatory professional.
Introduction to Clinical Research, Understand what clinical research is, how a drug is developed step by step, the four phases of clinical trials, and the difference between interventional and observational studies.
The People and the Framework, Meet the sponsor, CRO, SMO, investigator and site team, ethics committee and regulators, and learn how these parties interact to deliver a compliant trial.
Ethics and Regulations, Explore the ethical foundations of research, the ICH-GCP standard, India's New Drugs and Clinical Trials Rules 2019, informed consent as a process, protection of vulnerable participants and compensation for trial injury.
The Clinical Trial Lifecycle, Follow a trial from protocol design through feasibility, site start-up, recruitment and retention, conduct and monitoring, to a clean close-out.
Documents and Data, Learn how trial information is captured and controlled: source documents, case report forms and EDC, the ALCOA+ data-quality principles, essential documents in the TMF and ISF, and the delegation log.
Participant Safety and Pharmacovigilance, Understand adverse events, ADRs, serious adverse events and SUSARs, the timelines for reporting them, the role of pharmacovigilance, and how the investigational product is kept safe.
The Drug Development Pathway
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Trial Phases and Study Types
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Sponsors, CROs and SMOs
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The Investigator and the Site Team
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Ethics Committees and Regulators
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Ethical Principles and the Declaration of Helsinki
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ICH-GCP and India's NDCT Rules 2019
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Informed Consent, Vulnerable Participants and Compensation
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The Protocol and Feasibility
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Site Start-Up, Activation and Recruitment
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Conduct, Monitoring and Close-Out
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Source Documents and Case Report Forms
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ALCOA+ Data Quality Principles
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Essential Documents, the TMF, ISF and Delegation Log
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Adverse Events and Adverse Drug Reactions
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Serious Adverse Events, SUSARs and Reporting Timelines
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Pharmacovigilance and Investigational Product Safety
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6 modules · 18 lessons · Preview lessons are free to read; enroll to unlock the full course.
Clins Research Academy
Clins Research Pvt Ltd is a Clinical Research Site Management Organization (SMO) based in Gurugram. Our courses are designed and delivered by practitioners with hands-on experience across the clinical trial lifecycle.
