Coursera

Fundamentals of Good Clinical Practice: Prep and Personnel (Coursera)

Offered by Novartis,
Fundamentals of Good Clinical Practice: Prep and Personnel (Coursera)

Welcome to 'Fundamentals of Good Clinical Practice: Prep and Personnel'! This course is designed to introduce you to preparing for a clinical trial. This is Course Two in the Clinical Trial Teams series - the first course 'Introduction to Good Clinical Practice' provides background on what clinical trials are as well as the basic principles and practices of GCP. If you are new to the world of clinical research, we suggest starting your journey with Course One.

Class Deals by MOOC List - Click here and see Coursera's Active Discounts, Deals, and Promo Codes.

In Course Two, we turn our attention to the conduct of clinical trials, exploring in detail the role of the Investigator and site staff throughout a study.
Whether you are new to the field or seeking to refresh your knowledge, this course will equip you with the necessary understanding to begin to navigate the complex world of clinical research.
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.
We are excited to embark on this learning journey with you as we delve into the world of Good Clinical Practice. Enroll now and start building a strong foundation in the conduct of clinical research!
This course is part of the Clinical Trials: Good Clinical Practice Specialization.

What you'll learn
Explore the clinical trial process, the details of good clinical practice, and regulatory requirements.

Syllabus

Preparing for a Clinical Trial
In Week One, you'll learn about the preparations and qualification criteria required for an Investigator and their site to participate in a Clinical Trial, and learn about Site Selection Visits.

Preparing for a Clinical Trial, part 2
In Week Two, you'll continue to learn about the preparations and qualification criteria required for an Investigator and their site to participate in a Clinical Trial. Topics include essential documents, the role of the Institutional Review Board / Independent Ethics Committee (IRB / IEC), and source data and ALCOA+.

Investigator and Site Staff
In Week Three, you'll learn about the role and responsibilities of a Primary Investigator, including practical advice and guidance on how to succeed in the role. You'll also learn about how site staff support a clinical trial.

Go to Class
MOOC List is learner-supported. When you buy through links on our site, we may earn an affiliate commission.

Related Courses

Drug Commercialization (Coursera) Coursera
University of California, San Diego

Drug Commercialization (Coursera)

Health & Society Medicine & Pharmacology

The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Commercialization course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug commercialization. This course will cover pharmacoeconomic, marketing strategy, intellectual property strategy, portfolio management, managed markets and strategic alliances. It will also have a lecture case study from startup to success.

Sep 14th 2026
4 Weeks
Biotechnology Pharmaceutical Pharmacoeconomics
Details
Pre-formulation (Coursera) Coursera
Novartis

Pre-formulation (Coursera)

Health & Society

In this course we will focus on how active compounds are developed into a formulation suitable for dosing in animal studies and early human clinical trials.  Factors such as the route of administration, enhancing the solubility of the drug substance, the crystalline form of the drug substance, drug substance vs. drug product, storage requirements, and how special requirements of the patient population play a role in the design of an ideal formulation will be covered. 

Aug 24th 2026
3 Weeks
Clinical Trials Drugs Drug Development
Details
Innovate & Regulate: Drug Research, Costs, Clinical Trials & Approval (edX) EdX
Davidson College,DavidsonX

Innovate & Regulate: Drug Research, Costs, Clinical Trials & Approval (edX)

Medicine & Pharmacology

At some point in their life, essentially everyone needs to use medication for some type of disease treatment or cure. While medications offer great benefits, the cost of drugs, especially new drugs, and the lack of treatment for some diseases can raise questions about business activity behind the creation of new drugs. Better understanding of how drugs are discovered and developed as well as the legal and regulatory factors that affect the industry can help one better recognize both the shortcomings and opportunities faced by the drug industry at large.

Self Paced
Self-Paced
Biology Pharmaceutical Clinical Trials
Details
Introduction to Translational Research: Connecting Scientists and Medical Doctors (FutureLearn) FutureLearn
Taipei Medical University

Introduction to Translational Research: Connecting Scientists and Medical Doctors (FutureLearn)

Health & Society Social Sciences

Understand the emerging discipline of translational medicine and the process of taking research from ‘benchside’ to ‘bedside'. Translational medicine, also known as translational science or translational research, is a new, growing discipline in medicine that aims to ensure research flows from ‘benchside’ to ‘bedside’.

Self Paced
5-12 Weeks
Clinical Trials Drug Development Translational Research
Details
Preclinical Safety (Coursera) Coursera
Novartis

Preclinical Safety (Coursera)

Health & Society

Patient safety is of paramount importance for any drug discovery program.  This course looks at some of the lessons learned which have influenced how promising molecules are currently evaluated for safety risks.  In vitro and in vivo toxicology and safety studies are discussed, why they are performed, and how the data they provide guide a safety risk assessment, including determining a therapeutic index or safety window for a drug. 

Aug 24th 2026
3 Weeks
Toxicology Clinical Safety Drug Development
Details
Making Data Science Work for Clinical Reporting (Coursera) Coursera
Genentech

Making Data Science Work for Clinical Reporting (Coursera)

Statistics & Data Analysis Data Science

This course is aimed to demonstrate how principles and methods from data science can be applied in clinical reporting. By the end of the course, learners will understand what requirements there are in reporting clinical trials, and how they impact on how data science is used. The learner will see how they can work efficiently and effectively while still ensuring that they meet the needed standards.

Sep 7th 2026
4 Weeks
Github Clinical Trials Data Science
Details
Design and Conduct of Clinical Trials (Coursera) Coursera
Johns Hopkins University

Design and Conduct of Clinical Trials (Coursera)

Health & Society

In this course, you’ll learn how to design and carry out clinical trials. Each design choice has implications for the quality and validity of your results. This course provides you and your team with essential skills to evaluate options, make good design choices, and implement them within your trial. You’ll learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes.

Aug 24th 2026
4 Weeks
Clinical Trials Bias Recruitment
Details
Precision Medicine (Coursera) Coursera
University of Geneva

Precision Medicine (Coursera)

Sci: Biology & Life Sciences Health & Society

This course will provide you with the key knowledge and tools to understand the fundamentals and practical implications of precision medicine, its opportunities and challenges. It will address precision-medicine era diagnostics, treatment selection, genetic counseling, public health interventions, and biomedical research. It will also deal with data science and ethical issues. From genomic analysis and genetic counseling to cancer biomarkers, from risk assessment of chronic diseases to the understanding of gene-environment interactions, from pharmacogenomics to multi-omics data integration, experts will walk you through the many aspects of precision medicine, from the bench to the bedside and to population health.

Aug 24th 2026
5-12 Weeks
Medicine Health Cancer
Details