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Clinical Research Essentials
About this course
Clinical Research Fundamentals is a free course for anyone curious about how new drugs, devices, and treatments are tested in people career-changers, healthcare and life-science workers, and anyone exploring an entry role like Clinical Research Coordinator or Associate. The journey begins with what clinical research is and why it is so tightly regulated, then moves through the drug-development pipeline and trial phases, the ethics and human-subject protections that govern the field, Good Clinical Practice and the regulatory framework, the trial team and essential documents, informed consent and the IRB, how a trial is run day to day, and finally safety, monitoring, and closeout. Along the way the throughline is constant participant protection comes first and the stakes are anchored in real, named cases rather than abstract scenarios, reflecting current standards including ICH-GCP E6(R3).
At the completion of this course, learners will have confident foundational literacy in clinical research able to understand how trials work, who does what, and the rules that protect participants and data.
You will also receive a certificate to showcase your skills and step into the growing world of clinical research.
Course outline
Introduction to Clinical Research
In this module, you'll learn what clinical research is, why it is regulated, where it happens, key career roles (CRC, CRA, and beyond), and the importance of participant protection through the Gelsinger case.
The Drug Development Journey & Trial Phases
In this module, you'll learn how a treatment moves from discovery through preclinical work, the IND, and four clinical trial phases to approval, plus the device pathway and basic study types at an awareness level.
Ethics & Human Subject Protection
In this module, you'll learn the ethical history that shaped the field, from Nuremberg and Tuskegee to the Belmont principles, the Common Rule, and extra safeguards that protect vulnerable populations.
Good Clinical Practice (GCP) & the Regulatory Framework
In this module, you'll learn what Good Clinical Practice is and the role of ICH-GCP E6(R3), how the key FDA regulations fit together, and how to apply the ALCOA+ data-integrity principles.
The Clinical Trial Team & Key Documents
In this module, you'll learn who does what on a trial team (sponsor, PI, CRC, CRA, CRO), how delegation and Form FDA 1572 work, and the essential study documents that live in the regulatory binder.
Informed Consent & the IRB
In this module, you'll learn why informed consent is an ongoing process rather than a signature, what the IRB reviews and approves, and how consent can fail revisiting Gelsinger and special situations like minors and emergencies.
Conducting the Trial: Protocol, Visits & Data
In this module, you'll learn to read a protocol's key elements, understand study design basics like randomization and blinding, and follow the study-visit lifecycle and how data is captured through source documents, CRFs, and EDC.
Safety, Monitoring & Closeout + Your Path
In this module, you'll learn safety reporting (AEs, SAEs, and SUSARs), how monitoring, audits, and inspections work, how trials close out, and how to map your own path toward GCP training and certification.
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