Fundamentals of Good Clinical Practice: Prep and Personnel
Master comprehensive clinical trial preparation methodologies, including investigator responsibilities and site management following GCP guidelines.
Master comprehensive clinical trial preparation methodologies, including investigator responsibilities and site management following GCP guidelines.
This course cannot be purchased separately - to access the complete learning experience, graded assignments, and earn certificates, you'll need to enroll in the full Clinical Trials: Good Clinical Practice Specialization program. You can audit this specific course for free to explore the content, which includes access to course materials and lectures. This allows you to learn at your own pace without any financial commitment.
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What you'll learn
Understand clinical trial preparation requirements and site selection criteria
Master essential documentation and IRB/IEC submission processes
Implement ALCOA+ principles for source data management
Learn investigator responsibilities and oversight requirements
Develop site staff management and delegation skills
Skills you'll gain
This course includes:
0.8 Hours PreRecorded video
6 assignments
Access on Mobile, Tablet, Desktop
FullTime access
Shareable certificate
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There are 3 modules in this course
This course provides comprehensive training in preparing for and managing clinical trials according to Good Clinical Practice principles. Students learn about investigator qualifications, site selection processes, essential documentation requirements, IRB/IEC procedures, and ALCOA+ principles for source data. The curriculum covers investigator responsibilities, site staff management, and practical implementation of regulatory requirements in clinical research settings.
Preparing for a Clinical Trial
Module 1 · 20 Minutes to complete
Preparing for a Clinical Trial, part 2
Module 2 · 1 Hours to complete
Investigator and Site Staff
Module 3 · 1 Hours to complete
Fee Structure
Instructor
Empowering Global Workforce Development
Novartis Learning is a comprehensive educational initiative designed to enhance the skills and capabilities of its global workforce, which comprises approximately 108,000 employees across 140 countries. In partnership with Coursera, Novartis provides unlimited access to a vast catalog of over 3,600 courses, focusing on critical areas such as data science, digital technologies, and essential soft skills like leadership and problem-solving. This initiative aims to foster a culture of continuous learning and innovation within the company, enabling employees to adapt to the rapidly changing landscape of the biopharmaceutical industry.
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Frequently asked questions
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