Fundamentals of Good Clinical Practice: Prep and Personnel from 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.

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!

What's inside

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.

Good to know

Know what's good

, what to watch for

, and possible dealbreakers

Examines how to prepare for Phase II & Phase III clinical trials

Includes real-world case studies to provide context and understanding

Taught by Novartis Learning whose instructors are well-respected subject-matter experts on clinical trials

Provides an overview of basic clinical research concepts and principles

Suitable for those new to clinical research or those needing a refresher

Might be too basic and slow-going for some experienced clinical researchers

Career center

Learners who complete Fundamentals of Good Clinical Practice: Prep and Personnel will develop knowledge and skills that may be useful to these careers:

Clinical Research Manager

Clinical Research Managers have a foundation in Good Clinical Practice (GCP), so training in it is fundamental to success in this role. This course teaches the basics of GCP, including document management, site selection, and the role of the Institutional Review Board (IRB) / Independent Ethics Committee (IEC). Since Clinical Research Managers work in the pharmaceutical industry, they must be up-to-date on the latest standards and regulations, which this course provides.

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Clinical Research Associate

Clinical Research Associates (CRAs) are responsible for ensuring GCP compliance. This means that they must have a thorough understanding of how to conduct clinical trials in accordance with ethical and regulatory standards. This course provides the necessary training in GCP to be successful as a CRA. Additionally, CRAs are responsible for managing site staff, so the training in this course on the roles and responsibilities of site staff will be helpful.

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Investigator

Investigators are responsible for the overall conduct of clinical trials. This includes ensuring that the trial is conducted in accordance with GCP, protecting the rights and welfare of trial participants, and ensuring that the data collected is accurate and reliable. This course provides the necessary training in GCP for Investigators to be successful in their role. Additionally, the course provides practical advice and guidance on how to succeed as an Investigator.

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Data Manager

Data Managers are responsible for the management and analysis of clinical trial data. This includes ensuring that the data is accurate, complete, and reliable. This course provides the necessary training in GCP for Data Managers to be successful in their role. Additionally, the course provides training on source data and ALCOA+, which are essential concepts for Data Managers to understand.

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Regulatory Affairs Officer

Regulatory Affairs Officers are responsible for ensuring that clinical trials are conducted in accordance with regulatory requirements. This includes submitting regulatory documentation to government agencies and ensuring that the trial complies with all applicable laws and regulations. This course provides the necessary training in GCP for Regulatory Affairs Officers to be successful in their role. Additionally, the course provides training on preparing for a clinical trial, which is an essential part of the regulatory approval process.

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Quality Assurance Auditor

Quality Assurance Auditors are responsible for ensuring that clinical trials are conducted in accordance with GCP. This includes auditing clinical trial sites to ensure that they are compliant with regulations and standard operating procedures. This course provides the necessary training in GCP for Quality Assurance Auditors to be successful in their role. Additionally, the course provides training on document management and source data, which are essential concepts for Quality Assurance Auditors to understand.

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Biostatistician

Biostatisticians are responsible for the design and analysis of clinical trials. This includes developing statistical methods for analyzing clinical trial data and interpreting the results. This course may be useful for Biostatisticians who are new to the field of clinical research or who want to learn more about GCP. Additionally, the course provides training on preparing for a clinical trial, which is an essential part of the clinical trial design process.

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Pharmacist

Pharmacists are responsible for the dispensing and administration of drugs in clinical trials. This includes ensuring that the drugs are safe and effective and that they are used in accordance with the protocol. This course may be useful for Pharmacists who are new to the field of clinical research or who want to learn more about GCP. Additionally, the course provides training on preparing for a clinical trial, which is an essential part of the clinical trial process.

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Nurse

Nurses are responsible for the care of patients in clinical trials. This includes providing medical care, monitoring patients for adverse events, and collecting data. This course may be useful for Nurses who are new to the field of clinical research or who want to learn more about GCP. Additionally, the course provides training on preparing for a clinical trial, which is an essential part of the clinical trial process.

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Laboratory Technician

Laboratory Technicians are responsible for conducting laboratory tests in clinical trials. This includes collecting samples, analyzing data, and reporting results. This course may be useful for Laboratory Technicians who are new to the field of clinical research or who want to learn more about GCP. Additionally, the course provides training on preparing for a clinical trial, which is an essential part of the clinical trial process.

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Regulatory Compliance Manager

Regulatory Compliance Managers are responsible for ensuring that clinical trials are conducted in accordance with regulatory requirements. This includes developing and implementing policies and procedures, and training staff on regulatory compliance. This course may be useful for Regulatory Compliance Managers who are new to the field of clinical research or who want to learn more about GCP.

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Clinical Project Manager

Clinical Project Managers are responsible for the overall management of clinical trials. This includes planning, budgeting, and executing the trial. This course may be useful for Clinical Project Managers who are new to the field of clinical research or who want to learn more about GCP.

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Medical Writer

Medical Writers are responsible for writing clinical trial protocols, reports, and other documents. This course may be useful for Medical Writers who are new to the field of clinical research or who want to learn more about GCP.

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Data Analyst

Data Analysts are responsible for analyzing clinical trial data. This course may be useful for Data Analysts who are new to the field of clinical research or who want to learn more about GCP.

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Clinical Trial Coordinator

Clinical Trial Coordinators are responsible for the day-to-day management of clinical trials. This course may be useful for Clinical Trial Coordinators who are new to the field of clinical research or who want to learn more about GCP.

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