Fundamentals of Good Clinical Practice: Prep and Personnel
- Offered byCoursera
Fundamentals of Good Clinical Practice: Prep and Personnel at Coursera Overview
Duration | 2 hours |
Start from | Start Now |
Total fee | Free |
Mode of learning | Online |
Difficulty level | Beginner |
Official Website | Explore Free Course  |
Credential | Certificate |
Fundamentals of Good Clinical Practice: Prep and Personnel at Coursera Highlights
- Earn a certificate after completion of the course
- Assessment and quizzes
- Financial aid available
Fundamentals of Good Clinical Practice: Prep and Personnel 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: 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!
Fundamentals of Good Clinical Practice: Prep and Personnel at Coursera Curriculum
Preparing for a Clinical Trial
Introduction to the course
Preparing for a Site Selection Visit
About Site Selection Visits
Re-introduction to our characters
Week One Graded Assessment
Preparing for a Clinical Trial, part 2
Essential Documents for the IRB/IEC
What are Essential Documents?
Introducing the IRB/IEC
Working with the IRB/IEC
IRB/IEC Submission and Approval
Source Data & ALCOA+
Case Report Forms (CRF)
Electronic Medical Records
Assessment of Electronic Medical Records
List of Essential Documents
Requirements for Electronic Medical Records
Week Two Graded Assessment
Test Your Knowledge - Essential Documents
Investigator and Site Staff
Responsibilities of an Investigator
Becoming an Investigator
Form FDA 1572
Maintaining Oversight of Trials
Onboarding and Training Site Staff
Financial Disclosures
Site Staff and Delegation of Duties
Week Three Graded Assessment
Test Your Knowledge - Investigator's Responsibilities
Test Your Knowledge - Site Staff
Fundamentals of Good Clinical Practice: Prep and Personnel at Coursera Admission Process
Important Dates
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