Fundamentals of Good Clinical Practice: Recruitment & Trial
- Offered byCoursera
- Public/Government Institute
Fundamentals of Good Clinical Practice: Recruitment & Trial at Coursera Overview
Duration | 3 hours |
Total fee | Free |
Mode of learning | Online |
Official Website | Explore Free Course  |
Credential | Certificate |
- Overview
- Highlights
- Course Details
- Curriculum
Fundamentals of Good Clinical Practice: Recruitment & Trial at Coursera Highlights
- Earn a certificate after completion of the course
- Assessment and quizzes
- Financial aid available
Fundamentals of Good Clinical Practice: Recruitment & Trial at Coursera Course details
- What you'll learn
- Explore the clinical trial process, the details of good clinical practice, and regulatory requirements.
- 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!
Fundamentals of Good Clinical Practice: Recruitment & Trial at Coursera Curriculum
Recruitment & Enrollment of Patients
Introduction to the course
Recruitment Plan
Preparing for Site Initiation Visits
About Site Initiation Visits
Recruiting Patients
Enrolling Patients
Building Trust with Patients
Re-introduction to our characters
Dr. Novel's Recruitment Plan
Diversity & Inclusion in Recruitment
Week One Graded Assessment
Patient consent and working with vulnerable subjects
The Informed Consent Form
Electronic Informed Consent (eICF)
Recruiting Minors
Additional Considerations
Overcoming Language Barriers
Ensuring Patient Understanding
Obtaining Informed Consent
Who are Vulnerable Subjects?
Test Your Knowledge - Informed Consent
Test Your Knowledge - Vulnerable Subjects & Minors
Week Two Graded Assessment
Conducting a Clinical Trial
Source Documentation Checklist
Source Notes & CRF
Audit Trails
Data Flow
Monitoring Procedures
Importance of Protocol Compliance
Submitting Protocol Amendments
Audits & Inspections
Close-out & Archival Document Maintenance
Dr. Novel Recap
Remember ALCOA+
Essential Documents - Recap
Adverse Events
Assessing Causality
Monitoring - Further Reading
Audits vs Inspections
Test Your Knowledge - Documentation
Test Your Knowledge - Data Flow
Test Your Knowledge - Essential Documents
Test Your Knowledge - Adverse Events
Test Your Knowledge - Audits & Inspections
Week Three Graded Assessment
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