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Novartis Learning
Welcome to 'Fundamentals of Good Clinical Practice: Prep and Personnel'! This course is designed to introduce you to preparing for a clinical trial.
Read more
Welcome to 'Fundamentals of Good Clinical Practice: Prep and Personnel'! This course is designed to introduce you to preparing for a clinical trial.
Read more
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!
Register for this course and see more details by visiting:
OpenCourser.com/course/c68w1m/fundamentals
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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.
Read more
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.
Read more
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
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
Save this course
Save Fundamentals of Good Clinical Practice: Prep and Personnel to your list so you can find it easily later:
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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 Fundamentals of Good Clinical Practice: Prep and Personnel with these
activities:
Review prior knowledge of principles of data collection and quality assurance
Show steps
Revisiting previously covered materials will help refresh your memory and improve retention.
Show steps
-
Review class notes and textbooks
-
Complete practice problems or quizzes
Review Basics of Good Clinical Practice
Show steps
Review the foundational principles and practices of GCP to strengthen your understanding before diving into specific aspects of trial preparation.
Browse courses on
Good Clinical Practice
Show steps
-
Read through course materials from Course One: 'Introduction to Good Clinical Practice'
-
Familiarize yourself with key GCP guidelines and regulations
Complete practice questions on GCP compliance
Show steps
Engaging in practice questions will reinforce your understanding of GCP regulations and ensure compliance.
Browse courses on
Regulatory Compliance
Show steps
-
Find online practice questions or tests
-
Time yourself to simulate exam conditions
Five other activities
Expand to see all activities and additional details
Show all eight activities
Complete Practice Quizzes
Show steps
Test your understanding of the course material by actively completing practice quizzes and reviewing your performance to identify areas for improvement.
Show steps
-
Access the practice quizzes provided within the course modules
-
Attempt the quizzes and review your results
Explore Investigator Responsibilities
Show steps
Engage with online tutorials that delve into the crucial responsibilities and accountabilities of an Investigator.
Show steps
-
Identify relevant tutorials on platforms like Coursera or edX
-
Follow the tutorials, taking notes and completing any interactive exercises
Engage in Discussion Forums
Show steps
Actively participate in the course discussion forums to connect with fellow learners, share insights, and clarify concepts related to Investigator and site preparation.
Show steps
-
Read through existing forum posts and respond to questions
-
Initiate new discussions to seek clarification or share your perspectives
Organize Course Resources
Show steps
Consolidate your learning materials, including notes, assignments, and presentations, in a systematic manner to enhance your ability to review and retain information.
Show steps
-
Create a dedicated folder or notebook for course materials
-
Categorize and organize the materials according to topic or module
-
Regularly review and update your organized materials
Attend a GCP Workshop
Show steps
Participate in a workshop led by industry experts to gain practical insights and updates on GCP regulations, ethical considerations, and best practices in clinical trial conduct.
Show steps
-
Identify relevant GCP workshops or conferences
-
Register and attend the workshop
Review prior knowledge of principles of data collection and quality assurance
Show steps
Revisiting previously covered materials will help refresh your memory and improve retention.
Show steps
Show steps
Show steps
- Review class notes and textbooks
- Complete practice problems or quizzes
Review Basics of Good Clinical Practice
Show steps
Review the foundational principles and practices of GCP to strengthen your understanding before diving into specific aspects of trial preparation.
Browse courses on
Good Clinical Practice
Show steps
Show steps
Show steps
- Read through course materials from Course One: 'Introduction to Good Clinical Practice'
- Familiarize yourself with key GCP guidelines and regulations
Complete practice questions on GCP compliance
Show steps
Engaging in practice questions will reinforce your understanding of GCP regulations and ensure compliance.
Browse courses on
Regulatory Compliance
Show steps
Show steps
Show steps
- Find online practice questions or tests
- Time yourself to simulate exam conditions
Five other activities
Expand to see all activities and additional details
Show all eight activities
Complete Practice Quizzes
Show steps
Test your understanding of the course material by actively completing practice quizzes and reviewing your performance to identify areas for improvement.
Show steps
Show steps
Show steps
- Access the practice quizzes provided within the course modules
- Attempt the quizzes and review your results
Explore Investigator Responsibilities
Show steps
Engage with online tutorials that delve into the crucial responsibilities and accountabilities of an Investigator.
Show steps
Show steps
Show steps
- Identify relevant tutorials on platforms like Coursera or edX
- Follow the tutorials, taking notes and completing any interactive exercises
Engage in Discussion Forums
Show steps
Actively participate in the course discussion forums to connect with fellow learners, share insights, and clarify concepts related to Investigator and site preparation.
Show steps
Show steps
Show steps
- Read through existing forum posts and respond to questions
- Initiate new discussions to seek clarification or share your perspectives
Organize Course Resources
Show steps
Consolidate your learning materials, including notes, assignments, and presentations, in a systematic manner to enhance your ability to review and retain information.
Show steps
Show steps
Show steps
- Create a dedicated folder or notebook for course materials
- Categorize and organize the materials according to topic or module
- Regularly review and update your organized materials
Attend a GCP Workshop
Show steps
Participate in a workshop led by industry experts to gain practical insights and updates on GCP regulations, ethical considerations, and best practices in clinical trial conduct.
Show steps
Show steps
Show steps
- Identify relevant GCP workshops or conferences
- Register and attend the workshop
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 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.
Clinical Research Associate
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.
Investigator
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.
Data Manager
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.
Regulatory Affairs Officer
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.
Quality Assurance Auditor
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.
Biostatistician
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.
Pharmacist
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.
Nurse
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.
Laboratory Technician
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.
Regulatory Compliance Manager
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.
Clinical Project Manager
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.
Medical Writer
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.
Data Analyst
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.
Clinical Trial Coordinator
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.
For more career information including salaries, visit:
OpenCourser.com/course/c68w1m/fundamentals
Reading list
We've selected nine books
that we think will supplement your
learning. Use these to
develop background knowledge, enrich your coursework, and gain a
deeper understanding of the topics covered in
Fundamentals of Good Clinical Practice: Prep and Personnel.
Save
This report provides the ethical principles and guidelines for the protection of human subjects in research. It is an essential reference for anyone involved in the conduct of clinical trials.
Save
Provides a blend of practical guidance and theoretical insights on clinical trial design and management. It would be beneficial for learners seeking to gain a deeper understanding of the complexities and challenges involved in clinical research.
Provides a unique perspective on the art of clinical research. It covers topics such as study design, data analysis, and interpretation, and includes insights from the author's own experience.
This document provides guidance on the application of GCP guidelines to clinical trials of medicinal products involving paediatric populations. It covers topics such as study design, data collection, and reporting, and includes case studies and examples to illustrate key concepts.
Provides a comprehensive overview of the clinical trials process specifically in the field of psychiatry. It covers topics such as study design, data collection, and interpretation, and includes case studies and examples to illustrate key concepts.
Save
This textbook provides a methodologic approach to clinical trials, focusing on the design, conduct, and analysis of clinical research studies.
Save
Provides a practical guide to the monitoring of clinical trials. It covers topics such as site selection, data monitoring, and safety reporting, and includes case studies and examples to illustrate key concepts.
Save
Provides a solid foundation in biostatistics. It would be helpful for learners who need to refresh their knowledge of statistical concepts or seek a more in-depth understanding of statistical methods used in clinical research.
This toolkit provides a practical approach to GCP for researchers, covering topics such as study design, data management, and regulatory compliance.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/c68w1m/fundamentals
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Effort
3 weeks of study, 2 hours per week
Level
Introductory
Via
Coursera
Institution
Novartis
Instructor
Novartis Learning
Language
English
This course belongs to a
collection
called
Clinical Trials: Good Clinical Practice . It's comprised of three courses:
- Fundamentals of Good Clinical Practice: Recruitment & Trial
- Fundamentals of Good Clinical Practice: Prep and Personnel (viewing)
- Introduction to Good Clinical Practice
Good to know
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
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