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Fundamentals of Good Clinical Practice

Recruitment & Trial

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Novartis Learning

4.8

Based on 194 ratings

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Novartis Learning

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.

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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!

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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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Traffic lights

Read about what's good

what should give you pause

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

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Reviews summary

Foundational gcp for clinical trials

According to learners, this course provides a strong foundational understanding of Good Clinical Practice (GCP) principles related to patient recruitment, informed consent, and trial close-out procedures. Students praise the clear and logical structure, finding the practical examples and case studies highly beneficial for grasping complex guidelines. The well-explained concepts and quizzes are effective learning aids. While generally positive, a few learners noted that the pacing could feel slow for those with prior GCP knowledge, suggesting it's most impactful for beginners or as a comprehensive refresher.

The logical structure, clear videos, and quizzes enhance learning retention.

"The structure is logical, and the videos are clear. Novartis has done a commendable job."

"I found the bite-sized video lessons made the material manageable and easy to absorb."

"The quizzes really solidified my learning and helped me retain the information."

Highly relevant, applying GCP guidelines to real-world scenarios.

"The practical examples and case studies were incredibly helpful, making complex GCP guidelines easy to grasp."

"As a clinical research coordinator, this course greatly enhanced my understanding of trial close-out procedures and archiving."

"I appreciated that the information was accurate and aligned with current GCP standards."

Provides an excellent, easy-to-understand foundation in GCP principles.

"Excellent course for anyone looking to understand the core principles of patient recruitment and informed consent in clinical trials."

"This course is a solid foundational course, and it served as a great refresher for me, also ideal for beginners."

"As a newcomer to clinical research, I found this course perfect; the instructor explains concepts clearly."

Some experienced learners found the course's pace occasionally slow.

"While comprehensive, some parts felt a bit slow if you already have basic GCP knowledge."

"I found the content good but very dry, and I needed more interactive elements beyond just quizzes."

"It's good for ticking a box for compliance, but it wasn't particularly inspiring for an experienced professional."

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

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Gather and organize resources related to clinical trial design and conduct to enhance your understanding.

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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

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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

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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

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Develop a mock clinical trial protocol from scratch, putting into practice the knowledge gained from the course.

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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

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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.

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

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.

See salaries and explore the career path for Clinical Research Associate

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.

See salaries and explore the career path for Clinical Trial Coordinator

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.

See salaries and explore the career path for Investigator

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.

See salaries and explore the career path for Data Manager

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.

See salaries and explore the career path for Regulatory Affairs Specialist

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.

See salaries and explore the career path for Pharmacist

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.

See salaries and explore the career path for Nurse

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.

See salaries and explore the career path for Medical Writer

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.

See salaries and explore the career path for Statistician

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.

See salaries and explore the career path for Project Manager

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.

See salaries and explore the career path for Quality Assurance Auditor

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.

See salaries and explore the career path for Research Scientist

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.

See salaries and explore the career path for Healthcare Consultant

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.

See salaries and explore the career path for Science Writer

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.

See salaries and explore the career path for Patient Advocate

Reading list

We've selected five 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.

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Cover image

Clinical Trials

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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.

Clinical Trials: A Methodologic Perspective (Wiley...

Clinical Trials: A Methodologic Perspective (WILEY...

Clinical Trials: A Methodologic Perspective Second...

Principles and Practice of Clinical Trials

Clinical Trials: A Methodologic Perspective (Wiley...

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Cover image

Contemporary Issues for Protecting Patients in...

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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.

Contemporary Issues for Protecting Patients in...

Cover image

Cover image

Randomised Clinical Trials

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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.

Randomised Clinical Trials: Design, Practice and...

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Cover image

Group-Sequential Clinical Trials with Multiple Co...

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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.

Group-Sequential Clinical Trials with Multiple Co...

Group-Sequential Clinical Trials with Multiple Co...

Cover image

Cover image

Bioinformatics and RNA

Save

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.

Bioinformatics and RNA (Innovations in Big Data and...

Bioinformatics and RNA: A Practice-Based Approach...

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Rating

4.8

Effort

3 hours to complete

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

Traffic lights

Read about what's good

what should give you pause

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

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