ICH-GCP Training Refresher 2023 : Good Clinical Practice for Clinical Research Professionals

5/5
21
GCP clinical trial

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

This e-learning course is tailored for professionals who possess a basic understanding of the International Council on Harmonization and Good Clinical Practice (ICH-GCP) guidelines but want to stay current. It serves as a comprehensive review and delves into the roles and responsibilities of all stakeholders in the clinical research industry. The course is designed to be interactive, with quizzes and exercises that provide instant feedback on your understanding. This approach allows for an optimized learning experience. To gauge your comprehension, there will be a final assessment, and additional resources, updates, and your recognized certification can be accessed on our learning platform.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

Curriculum:

 

Lesson 1: Introduction

 

Lesson 2: Definitions of key terms used in GCP

 

Lesson 3: The 13 principles of ICH-GCP (R2)

 

Lesson 4: Institutional review board (IRB)/ Independent Ethics Committee (IEC)

 

Lesson 5: Responsibilities of the investigator

 

Lesson 6: Responsabilities of the sponsor

 

Lesson 7: Clinical trial protocol and protocol amendments

 

Lesson 8: Investigator’s Brochure

 

Lesson 9: Essential Documents

 

Lesson 10:  Septembre 2022- Upcoming revision 3 (R3) of ICH-GCP

 

Conclusion

 

Glossary

 

Evaluation

Author:

patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She worked as Clinical Research Associate at Pfizer, GSK, AstraZeneca and she takes part in many startups boards.

Reviews:

5/5
21
USD: United States (US) dollar ($)

$60

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This course includes:
Full lifetime access
Updated content every month
Certificate of completion

GxP-Training Benefits

$60.00

$60.00

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