Home / Online GXP courses / GCP : Clinical Trials / ICH-GCP Training Refresher 2023 : Good Clinical Practice for Clinical Research Professionals

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

 5/5

21

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:

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

I appreciated the format of the GCP inspection course offered by GxP Training. It was easy to navigate through the educational modules and ultimately the final test. The information was presented in a clear concise way.

$60

Buy now

This course includes:

Full lifetime access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.