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Welcome to 'Fundamentals of Good Clinical Practice: Recruitment and Trial'!
Read more
Welcome to 'Fundamentals of Good Clinical Practice: Recruitment and Trial'!
Read more
Welcome to 'Fundamentals of Good Clinical Practice: Recruitment and Trial'!
This is the third course in the Clinical Trial GCP series. It is designed to introduce you to the processes, procedures and documentation needed prior, during and after a clinical trial according to Good Clinical Practice (GCP).
In Courses One and Two, we explored the foundations of clinical research, including the preparations and documentation needed to begin a trial as well as the role of the investigator, site staff and the IRB/IEC. We conclude our GCP studies with this final course.
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.
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/4bffc0/fundamentals
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What's inside
Syllabus
Recruitment & Enrollment of Patients
In Week One, you'll learn about the processes for recruiting and enrolling patients, including how to build a recruitment plan.
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Syllabus
Recruitment & Enrollment of Patients
In Week One, you'll learn about the processes for recruiting and enrolling patients, including how to build a recruitment plan.
Read more
Patient consent and working with vulnerable subjects
In Week Two, we’ll focus on the consent process, and also discuss what to consider when working with vulnerable patient groups.
Conducting a Clinical Trial
In Week Three, you'll learn about key documentation, and processes and procedures that occur when conducting a clinical trial which help to ensure protocol compliance. We also cover the steps involved in closing out and archiving a trial.
Good to know
Good to know
Know what's good ,
what to watch for , and
possible dealbreakers
Teaches key documentation, processes & procedures for managing clinical trials
Provides interactive quizzes & videos to enhance understanding of clinical research
Focuses on patient consent & working with vulnerable subjects
Designed for those seeking a foundation in clinical research
Involves Novartis Learning as its instructors
Save this course
Save Fundamentals of Good Clinical Practice: Recruitment & Trial 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: Recruitment & Trial with these
activities:
Find a Mentor in Clinical Research
Show steps
Connect with a mentor to gain personalized guidance and support throughout your learning journey in clinical research.
Show steps
-
Identify potential mentors within your network or through professional organizations.
-
Reach out to individuals and express your interest in mentorship.
-
Schedule regular meetings to discuss your progress and seek guidance.
Compilation: Clinical Trial Resources
Show steps
Gather and organize resources related to clinical trial design and conduct to enhance your understanding.
Show steps
-
Search for relevant resources, including articles, guidelines, and databases.
-
Create a central repository or document to store the resources.
-
Categorize and organize the resources for easy access.
-
Share the compilation with other students or professionals.
Handbook of Clinical Trials
Show steps
Review the Handbook of Clinical Trials to expand your understanding of various aspects of clinical trial conduct.
View
Labour, Finance and Inequality: The Insecurity...
on Amazon
Show steps
-
Read the relevant chapters on recruitment, enrollment, consent, and trial management.
-
Summarize the key concepts and principles outlined in the book.
-
Critically evaluate the strengths and limitations of the information presented.
Two other activities
Expand to see all activities and additional details
Show all five activities
Project: Clinical Trial Protocol Development
Show steps
Develop a mock clinical trial protocol from scratch, putting into practice the knowledge gained from the course.
Show steps
-
Define the research question and objectives.
-
Design the study methodology, including recruitment criteria, intervention, and data collection methods.
-
Develop a data management and analysis plan.
-
Write a detailed protocol document.
-
Seek feedback from experts in the field.
Workshop: GCP Compliance in Clinical Trials
Show steps
Attend a workshop to gain practical insights into GCP compliance and best practices in clinical trials.
Show steps
-
Identify a workshop that aligns with the topics covered in the course.
-
Register and attend the workshop.
-
Actively participate in discussions and exercises.
-
Network with other professionals in the field.
-
Reflect on the key takeaways and apply them to your own work.
Find a Mentor in Clinical Research
Show steps
Connect with a mentor to gain personalized guidance and support throughout your learning journey in clinical research.
Show steps
Show steps
Show steps
- Identify potential mentors within your network or through professional organizations.
- Reach out to individuals and express your interest in mentorship.
- Schedule regular meetings to discuss your progress and seek guidance.
Compilation: Clinical Trial Resources
Show steps
Gather and organize resources related to clinical trial design and conduct to enhance your understanding.
Show steps
Show steps
Show steps
- Search for relevant resources, including articles, guidelines, and databases.
- Create a central repository or document to store the resources.
- Categorize and organize the resources for easy access.
- Share the compilation with other students or professionals.
Handbook of Clinical Trials
Show steps
Review the Handbook of Clinical Trials to expand your understanding of various aspects of clinical trial conduct.
View
Labour, Finance and Inequality: The Insecurity...
on Amazon
Show steps
Show steps
Show steps
- Read the relevant chapters on recruitment, enrollment, consent, and trial management.
- Summarize the key concepts and principles outlined in the book.
- Critically evaluate the strengths and limitations of the information presented.
Two other activities
Expand to see all activities and additional details
Show all five activities
Project: Clinical Trial Protocol Development
Show steps
Develop a mock clinical trial protocol from scratch, putting into practice the knowledge gained from the course.
Show steps
Show steps
Show steps
- Define the research question and objectives.
- Design the study methodology, including recruitment criteria, intervention, and data collection methods.
- Develop a data management and analysis plan.
- Write a detailed protocol document.
- Seek feedback from experts in the field.
Workshop: GCP Compliance in Clinical Trials
Show steps
Attend a workshop to gain practical insights into GCP compliance and best practices in clinical trials.
Show steps
Show steps
Show steps
- Identify a workshop that aligns with the topics covered in the course.
- Register and attend the workshop.
- Actively participate in discussions and exercises.
- Network with other professionals in the field.
- Reflect on the key takeaways and apply them to your own work.
Career center
Learners who complete Fundamentals of Good Clinical Practice: Recruitment & Trial will develop knowledge and skills
that may be useful to these careers:
Clinical Research Associate
Clinical Research Associate
A Clinical Research Associate (CRA) plays a vital role in ensuring that clinical trials are conducted safely and ethically. They work closely with investigators, site staff, and sponsors to manage all aspects of a clinical trial, from patient recruitment and enrollment to data collection and analysis. This course provides a strong foundation in the principles of Good Clinical Practice (GCP), which are essential for CRAs to follow in their work. By completing this course, you will gain a comprehensive understanding of the processes and procedures involved in clinical trials, enabling you to excel in your role as a CRA.
Investigator
Investigator
Investigators are responsible for designing and conducting clinical trials. They work closely with sponsors and regulatory authorities to ensure that trials are conducted safely and ethically. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to design and conduct clinical trials that meet the highest ethical and scientific standards.
Clinical Trial Coordinator
Clinical Trial Coordinator
Clinical Trial Coordinators are responsible for the day-to-day operations of clinical trials. They work closely with the Principal Investigator to manage patient recruitment and enrollment, collect and manage data, and ensure that the trial is conducted according to GCP guidelines. This course provides a comprehensive overview of the role of a Clinical Trial Coordinator and the key principles of GCP. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and contribute to the success of clinical trials.
Data Manager
Data Manager
Data Managers are responsible for managing and analyzing clinical trial data. They work closely with investigators, statisticians, and programmers to ensure that data is accurate, complete, and reliable. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to manage and analyze clinical trial data effectively.
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Regulatory Affairs Specialists are responsible for ensuring that clinical trials are conducted in compliance with all applicable laws and regulations. They work closely with investigators, sponsors, and regulatory authorities to ensure that trials are conducted safely and ethically. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and ensure that clinical trials are conducted in compliance with all applicable laws and regulations.
Pharmacist
Pharmacist
Pharmacists play a vital role in clinical trials by ensuring that patients receive the correct medication at the correct dose and time. They also work closely with investigators and other healthcare professionals to monitor patients for adverse events and drug interactions. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and ensure that patients receive the best possible care during clinical trials.
Nurse
Nurse
Nurses play a vital role in clinical trials by providing care to patients and monitoring their health. They also work closely with investigators and other healthcare professionals to ensure that patients are treated according to the protocol and that all data is collected accurately. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and ensure that patients receive the best possible care during clinical trials.
Medical Writer
Medical Writer
Medical Writers are responsible for writing and editing clinical trial protocols, reports, and other documents. They work closely with investigators, sponsors, and regulatory authorities to ensure that all documents are accurate, complete, and compliant with all applicable laws and regulations. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and ensure that all clinical trial documents are of the highest quality.
Statistician
Statistician
Statisticians play a vital role in clinical trials by designing and analyzing statistical plans and data. They work closely with investigators and other healthcare professionals to ensure that trials are conducted scientifically and that the results are valid and reliable. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and ensure that clinical trials are conducted to the highest scientific standards.
Project Manager
Project Manager
Project Managers are responsible for planning, organizing, and executing clinical trials. They work closely with investigators, sponsors, and other stakeholders to ensure that trials are conducted on time, within budget, and in compliance with all applicable laws and regulations. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and ensure that clinical trials are conducted efficiently and effectively.
Quality Assurance Auditor
Quality Assurance Auditor
Quality Assurance Auditors are responsible for ensuring that clinical trials are conducted in compliance with GCP and all applicable laws and regulations. They work closely with investigators, sponsors, and other stakeholders to identify and mitigate risks and ensure that trials are conducted to the highest standards of quality. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and ensure that clinical trials are conducted to the highest standards of quality.
Research Scientist
Research Scientist
Research Scientists are involved in all aspects of clinical research, from designing and conducting trials to analyzing data and writing reports. They work closely with investigators, sponsors, and other healthcare professionals to advance medical knowledge and improve patient care. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and contribute to the advancement of medical research.
Healthcare Consultant
Healthcare Consultant
Healthcare Consultants provide advice and guidance to healthcare organizations on a variety of topics, including clinical research. They work closely with clients to identify and address challenges, develop strategies, and improve patient care. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and provide valuable advice to healthcare organizations on all aspects of clinical research.
Science Writer
Science Writer
Science Writers communicate complex scientific information to a wide audience. They work closely with scientists, researchers, and other experts to develop and write articles, reports, and other materials that are accurate, engaging, and informative. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and communicate the importance of clinical research to a wide audience.
Patient Advocate
Patient Advocate
Patient Advocates represent the interests of patients in clinical trials and other healthcare settings. They work closely with patients and their families to ensure that they understand their rights, have access to quality care, and are treated with respect. This course provides a strong foundation in the principles of GCP and the processes and procedures involved in clinical trials. By completing this course, you will gain the knowledge and skills necessary to succeed in this role and advocate for the rights of patients in clinical trials.
For more career information including salaries, visit:
OpenCourser.com/course/4bffc0/fundamentals
Reading list
We've selected seven 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: Recruitment & Trial.
Save
This textbook provides a comprehensive overview of clinical trial design and methodology. It covers essential topics such as study design, data collection, and statistical analysis. For individuals with no background in clinical trials, this book is highly recommended.
Focuses on the ethical and practical aspects of informed consent in clinical trials. It provides guidance to investigators, IRB members, and other professionals involved in the consent process. Reading this book is beneficial for gaining a specialized understanding of informed consent.
Provides a comprehensive overview of the statistical designs used in clinical trials. It covers topics such as the one-sample t-test, the two-sample t-test, and the analysis of variance.
Provides a comprehensive overview of the statistical methods used in clinical research. It covers topics such as descriptive statistics, inferential statistics, and regression analysis.
Provides a methodological perspective on the design and conduct of clinical trials. It covers topics such as the ethical principles of clinical research, the role of the Institutional Review Board, and the management of conflicts of interest.
Comprehensive guide to the design of clinical trials. It covers topics such as the choice of study design, the determination of sample size, and the selection of statistical methods.
Provides an overview of the current and emerging applications of proteomics in clinical research. It covers topics such as biomarker discovery, disease diagnosis, and drug development.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/4bffc0/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 (viewing)
- Fundamentals of Good Clinical Practice: Prep and Personnel
- Introduction to Good Clinical Practice
Good to know
Teaches key documentation, processes & procedures for managing clinical trials
Provides interactive quizzes & videos to enhance understanding of clinical research
Focuses on patient consent & working with vulnerable subjects
Designed for those seeking a foundation in clinical research
Involves Novartis Learning as its instructors
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