Fundamentals of Good Clinical Practice: Recruitment & Trial
Keep adding new skills with 10,000+ programs for $239 (usually $399). Save now.
Fundamentals of Good Clinical Practice: Recruitment & Trial
This course is part of Clinical Trials: Good Clinical Practice Specialization
Instructor: Novartis Learning
10,711 already enrolled
Included with
Ask Coursera
223 reviews
Recommended experience
223 reviews
Recommended experience
What you'll learn
Explore the clinical trial process, the details of good clinical practice, and regulatory requirements.
Details to know
See how employees at top companies are mastering in-demand skills
Build your subject-matter expertise
- Learn new concepts from industry experts
- Gain a foundational understanding of a subject or tool
- Develop job-relevant skills with hands-on projects
- Earn a shareable career certificate
There are 3 modules in this course
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!
In Week One, you'll learn about the processes for recruiting and enrolling patients, including how to build a recruitment plan.
What's included
7 videos3 readings1 assignment
7 videos•Total 18 minutes
- Introduction to the course•2 minutes
- Recruitment Plan•2 minutes
- Preparing for Site Initiation Visits•1 minute
- About Site Initiation Visits•4 minutes
- Recruiting Patients•2 minutes
- Enrolling Patients•4 minutes
- Building Trust with Patients•3 minutes
3 readings•Total 18 minutes
- Re-introduction to our characters•3 minutes
- Dr. Novel's Recruitment Plan•5 minutes
- Diversity & Inclusion in Recruitment•10 minutes
1 assignment•Total 10 minutes
- Week One Graded Assessment•10 minutes
In Week Two, we’ll focus on the consent process, and also discuss what to consider when working with vulnerable patient groups.
What's included
6 videos2 readings3 assignments
6 videos•Total 12 minutes
- The Informed Consent Form•2 minutes
- Electronic Informed Consent (eICF)•2 minutes
- Recruiting Minors•2 minutes
- Additional Considerations•2 minutes
- Overcoming Language Barriers•1 minute
- Ensuring Patient Understanding•3 minutes
2 readings•Total 20 minutes
- Obtaining Informed Consent•10 minutes
- Who are Vulnerable Subjects?•10 minutes
3 assignments•Total 30 minutes
- Week Two Graded Assessment•20 minutes
- Test Your Knowledge - Informed Consent•5 minutes
- Test Your Knowledge - Vulnerable Subjects & Minors•5 minutes
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.
What's included
9 videos7 readings6 assignments
9 videos•Total 19 minutes
- Source Documentation Checklist•2 minutes
- Source Notes & CRF•2 minutes
- Audit Trails•2 minutes
- Data Flow•4 minutes
- Monitoring Procedures•2 minutes
- Importance of Protocol Compliance•2 minutes
- Submitting Protocol Amendments•2 minutes
- Audits & Inspections•2 minutes
- Close-out & Archival Document Maintenance•3 minutes
7 readings•Total 65 minutes
- Dr. Novel Recap•5 minutes
- Remember ALCOA+•10 minutes
- Essential Documents - Recap•10 minutes
- Adverse Events•10 minutes
- Assessing Causality •10 minutes
- Monitoring - Further Reading•10 minutes
- Audits vs Inspections•10 minutes
6 assignments•Total 45 minutes
- Week Three Graded Assessment•20 minutes
- Test Your Knowledge - Documentation•5 minutes
- Test Your Knowledge - Data Flow•5 minutes
- Test Your Knowledge - Essential Documents•5 minutes
- Test Your Knowledge - Adverse Events•5 minutes
- Test Your Knowledge - Audits & Inspections•5 minutes
Earn a career certificate
Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.
Instructor
Explore more from Research
- Status: Free Trial
Course
- Status: Free Trial
Course
- Status: Free Trial
Specialization
- Status: Free TrialJ
Johns Hopkins University
Course
Why people choose Coursera for their career
Learner reviews
- 5 stars
84.75%
- 4 stars
12.10%
- 3 stars
2.24%
- 2 stars
0.44%
- 1 star
0.44%
Showing 3 of 223
Reviewed on Oct 11, 2024
This course is amazing in its simple yet comprehensive way in touching all important aspects in a concise manner, with link to further reading for details. Thank you so much Novartis
Reviewed on May 19, 2025
A very helpful course which helped me for better understanding of Clinical trials and associated Good Laboratory Practices
Reviewed on Nov 18, 2024
Very informative! Information was presented in a concise and engaging format. I really enjoyed the course. It was well done.
Frequently asked questions
To access the course materials, assignments and to earn a Certificate, you will need to purchase the Certificate experience when you enroll in a course. You can try a Free Trial instead, or apply for Financial Aid. The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. Your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile.
Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.
More questions
Financial aid available,