The "Introduction to Clinical Trials" course is a comprehensive introduction to the world of medicinal product research. Designed for individuals interested in developing a career in clinical research, it provides both theoretical and practical knowledge related to planning, conducting, and evaluating clinical studies. 

COURSE OBJECTIVES

• You will develop skills in designing and conducting clinical trials in accordance with current standards and regulations.
• You will master techniques for monitoring and reporting clinical trial progress, enabling effective control of research quality and compliance.
• You will learn how to collaborate efficiently with research teams and regulatory organizations, ensuring adherence to legal and ethical requirements.
• You will complete a project that allows you to apply clinical research knowledge in practice, considering participant diversity and the specifics of the medicinal product under investigation.
• You will gain knowledge of legal regulations, GCP principles, and the role of diversity in clinical trials, helping you approach challenges in new drug development professionally.
• You will acquire solid theoretical foundations and practical guidance that will support your growth in the dynamic field of clinical research.

TOPICS COVERED

MODULE 1 & 2

Fundamentals of Clinical Trials

In the first and second modules, you will learn about the basics of clinical trials, including trial phases, objectives, and their application in medicine. 

MODULE 3

Clinical Trial Monitoring

In the third module, you will explore procedures for monitoring clinical trials, ensuring their quality and adherence to the study protocol. 

MODULE 4

Audit and Inspections in Clinical Trials

In the fourth module, you will learn how to prepare for clinical trial audits and inspections, as well as how to ensure compliance with applicable regulations. 

MODULE 5

Pharmacovigilance

In the fifth module, you will learn the principles of medicinal product safety, risk analysis, and procedures associated with pharmacovigilance. 

MODULE 6

Ethics and Legal Aspects in Clinical Research

In the sixth module, you will explore ethical principles and legal regulations related to clinical trials, including Good Clinical Practice (GCP) standards. 

MODULE 7

Clinical Trial Registration

In the seventh module, you will learn how clinical trials are registered and how to effectively publish results in the scientific community. 

MODULE 8

Diversity in Clinical Research

In the eighth module, you will discover the importance of diversity in clinical trials and how inclusivity influences participant selection. 

COURSE COMPLETION AND CERTIFICATION REQUIREMENTS

The course includes eight knowledge assessments, one for each module. Review all learning materials provided within the modules and achieve at least 60% on each test to pass the course and receive a certificate. You may attempt each test up to three times. 

COURSE TEAM

Agata Wiesiołek
Executive Director at AstraZeneca, expert in global clinical trials

Patrycja Florczuk-Kołomyja
Associate Director and expert in local clinical trials at AstraZeneca

Olga Bogaczyńska
Director of Process Compliance at AstraZeneca, expert in audits and research oversight

Marek Rychter
Associate Director for Regulatory Affairs at AstraZeneca

Wiktor Krzymowski
Doctor of Law specializing in pharmaceutical law, attorney at AstraZeneca

Kamil Kuhr
Director of Research & Development Education at AstraZeneca, expert in diversity and education

Aleksandra Tyl-Płóciennik
Associate Director and expert in risk-based clinical quality management at AstraZeneca 

Aleksander Dalewski
Senior Director for Study Management and Innovation at AstraZeneca, expert in global clinical trials

Andrzej Kinasiewicz
Director of Central Monitoring, expert in risk-based clinical quality management at AstraZeneca

Michał Chrzanowski
Associate Director for Compliance and Inspection Excellence, expert in pharmacotherapy safety monitoring at AstraZeneca

Alicja Ochmańska
Associate Director for Oncology Regulatory Affairs at AstraZeneca, expert in diversity

Anna Grudnicka
Senior Director for Clinical Portfolio Management, expert in oncology research 

Natalia Łojko
Head of Legal Department at AstraZeneca