Introduction to Good Clinical Practice from Coursera

Welcome to 'Introduction to Good Clinical Practice'! This course is designed to introduce you to the basic principles and practices of Good Clinical Practice (GCP), which are essential for conducting clinical trials and ensuring the safety and well-being of human subjects. Whether you are new to the field or seeking to refresh your knowledge, this course and its sequel courses covering the fundamentals of Good Clinical Practice will equip you with the necessary skills and understanding to begin to navigate the complex world of clinical research.

Developed by industry experts, the course offers an introduction to the key concepts, guidelines, and regulatory requirements outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP guidelines.

During this course, you will explore the essential elements of Good Clinical Practice and gain insights into its significance in the global clinical research arena. By the end of the course, you will have a solid understanding of the principles of GCP and its role in ensuring the integrity and reliability of clinical trial data.

The course is divided into several modules, each covering specific aspects of GCP. The modules include video lectures and interactive quizzes to reinforce your learning. You can progress through the course at your own pace, allowing you to fit your studies around your existing commitments and responsibilities.

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 clinical research ethics and regulations!

What's inside

Syllabus

Module One Introduction

In Module One you’ll learn the basics of what a clinical trial is. You’ll hear from investigators, patients, and sponsors about the benefits of clinical trials, and you’ll learn about the drug discovery process.

Module Two Introduction

In Module Two we’ll focus on some important rules and regulations. You’ll find out why good clinical practice matters and learn about the history of regulatory frameworks for medical treatment and testing. We’ll also explore some clinical trial definitions, look at informed consent, talk about risk, and discuss data integrity.

Module Three Introduction

In Module Three we’ll explore how research in clinical trials makes a difference. We’ll also walk you through what medical teams and patients must do to become involved. You’ll learn about the importance of diversity in clinical trials, inclusion and exclusion criteria, and we’ll hear from some patients who’ll tell us how they experienced the trial process.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Teaches essential Good Clinical Practice principles and practices

Covers key concepts to navigate the complex world of clinical research

Offered by Novartis Learning, recognized for expertise in the field

Provides insights into regulatory requirements for clinical trials

Covers the importance of diversity and inclusion in clinical trials

Content includes video lectures and interactive quizzes

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Introduction to Good Clinical Practice with these activities:

Review basic clinical trial concepts

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Reinforce your understanding of foundational principles and regulations in clinical trials.

Browse courses on Good Clinical Practice (GCP)

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Read relevant articles or textbooks on GCP
Summarize key concepts and definitions related to clinical trials
Review case studies or examples to understand the practical application of GCP

Form a study group with classmates or colleagues

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Collaborate with others to discuss course concepts and reinforce your learning.

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Identify individuals who are also enrolled in the course or have relevant experience
Establish a regular meeting schedule and set clear goals for each session
Take turns presenting and discussing key concepts, case studies, or research findings

Practice identifying common ethical issues in clinical research

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Develop your ability to recognize and address ethical dilemmas in clinical trials.

Browse courses on Informed Consent

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Analyze case studies or scenarios involving ethical issues
Identify potential biases or conflicts of interest
Discuss and debate different perspectives on ethical issues

Three other activities

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Attend a GCP workshop or conference

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Gain insights and connect with professionals in the field of clinical research.

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Research and identify relevant GCP workshops or conferences
Register and attend the event
Engage actively in sessions, workshops, and networking opportunities

Develop a mock Informed Consent Form (ICF)

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Apply your understanding of informed consent principles by creating a realistic ICF.

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Research and understand the elements of a well-written ICF
Draft an outline of the key information to be included in the ICF
Write the first version of the ICF
Review and revise the ICF for clarity and comprehensiveness

Contribute to open-source projects related to clinical research

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Apply your GCP knowledge and contribute to the advancement of clinical research.

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Identify open-source projects that align with your interests and GCP expertise
Review the project's documentation and contribute code, documentation, or other resources
Collaborate with other developers and researchers to enhance the project

Career center

Learners who complete Introduction to Good Clinical Practice will develop knowledge and skills that may be useful to these careers:

Clinical Research Associate

A Clinical Research Associate (CRA) plays a pivotal role in the clinical trial process. They ensure that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines and regulations. This course provides a comprehensive overview of GCP, including its key concepts, guidelines, and regulatory requirements. By understanding GCP, CRAs can effectively manage clinical trial sites, monitor patient safety, and ensure data integrity. This course can help CRAs enhance their knowledge and skills, enabling them to excel in their roles.

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Quality Assurance Auditor

A Quality Assurance Auditor ensures that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines and regulations. They review clinical trial documentation, inspect clinical trial sites, and monitor data collection and analysis. This course provides a comprehensive overview of GCP, including its principles, guidelines, and regulatory requirements. By understanding GCP, Quality Assurance Auditors can effectively assess the quality and compliance of clinical trials, identify areas for improvement, and ensure the safety and well-being of research participants.

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Clinical Research Coordinator

A Clinical Research Coordinator assists in the planning, implementation, and coordination of clinical trials. They play a vital role in ensuring that clinical trials are conducted ethically and in compliance with Good Clinical Practice (GCP) guidelines. This course provides a solid foundation in GCP, enabling Clinical Research Coordinators to understand the principles, regulations, and responsibilities involved in clinical research. By gaining a deep understanding of GCP, they can effectively manage clinical trial logistics, coordinate study activities, and ensure the well-being of research participants.

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Regulatory Affairs Specialist

A Regulatory Affairs Specialist ensures that clinical trials are conducted in compliance with applicable laws and regulations. They prepare and submit regulatory documentation, such as clinical trial applications and investigational new drug applications (INDs). This course provides a strong foundation in Good Clinical Practice (GCP), which is essential for understanding the regulatory requirements for clinical trials. By understanding GCP guidelines, Regulatory Affairs Specialists can effectively navigate the regulatory landscape, ensure compliance, and protect the rights and safety of research participants.

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Medical Writer

A Medical Writer creates and manages scientific and medical documents, such as clinical trial protocols, investigator brochures, and patient information sheets. They play a vital role in ensuring that clinical trials are conducted ethically and in compliance with Good Clinical Practice (GCP) guidelines. This course provides a comprehensive overview of GCP, including its principles, regulations, and documentation requirements. By understanding GCP, Medical Writers can effectively develop clear and accurate clinical trial documents that meet regulatory standards and ensure the safety and well-being of research participants.

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Pharmacovigilance Scientist

A Pharmacovigilance Scientist monitors the safety of drugs and vaccines after they have been released to the market. They collect, analyze, and interpret data on adverse drug reactions and other safety concerns. This course provides a solid foundation in Good Clinical Practice (GCP), which is essential for ensuring the safety and well-being of human subjects in clinical trials. By understanding GCP guidelines, Pharmacovigilance Scientists can effectively evaluate the safety of drugs and vaccines, identify and manage risks, and communicate safety information to healthcare professionals and the public.

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Data Manager

A Data Manager is responsible for managing and analyzing clinical trial data. They ensure the accuracy, integrity, and security of data throughout the clinical research process. This course provides a strong foundation in Good Clinical Practice (GCP), which is essential for ensuring the quality and reliability of clinical trial data. By understanding GCP guidelines, Data Managers can effectively design and implement data management plans, monitor data collection, and ensure data integrity. This course can help Data Managers enhance their skills and knowledge, enabling them to succeed in their roles.

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Research Scientist

A Research Scientist conducts scientific research in various fields, including medicine, biology, and chemistry. They design and conduct experiments, analyze data, and publish their findings in scientific journals. This course provides a solid foundation in Good Clinical Practice (GCP), which is essential for conducting ethical and scientifically sound research. By understanding GCP guidelines, Research Scientists can ensure the integrity of their research, protect the rights and safety of research participants, and contribute to the advancement of scientific knowledge.

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Statistician

A Statistician uses statistical methods to analyze data and draw conclusions. They work in various fields, including medicine, public health, and finance. This course provides a strong foundation in Good Clinical Practice (GCP), which is essential for understanding the statistical methods used in clinical trials. By understanding GCP guidelines, Statisticians can effectively design and conduct statistical analyses, interpret data, and communicate their findings to researchers, clinicians, and policymakers.

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Biostatistician

A Biostatistician manages and analyzes health data for the purpose of answering questions about biomedical research or public health. They design and implement statistical methods for data collection, analysis, and interpretation. This course helps build a foundation in the principles and practices of Good Clinical Practice (GCP), which are essential for conducting clinical trials and ensuring the safety and well-being of human subjects. Since the work of a Biostatistician heavily involves designing and implementing statistical methods in clinical research, understanding GCP is crucial for success in this role.

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Introduction to Good Clinical Practice

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