11-13-2023, 06:40 AM
Clinical Research: Mastering Good Clinical Practices (GCP)
Adhere to ICH GCP Guidelines for Ethical and Rigorous Clinical Trials
New
Rating: 0.0 out of 5
(0 ratings)
288 students
1.5 hours on-demand video
Course Description
This comprehensive Good Clinical Practices (GCP) course provides a thorough understanding of the ethical and regulatory principles governing clinical trials. It delves into the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, ensuring you grasp the essential standards for conducting clinical research.
Course Objectives
By the end of this course, you will be able to:
Articulate the definition, purpose, and historical context of GCP.
Explain the importance of GCP in protecting human subjects and ensuring data integrity.
Identify key international organizations involved in establishing GCP standards.
Apply ethical principles and informed consent procedures in clinical research.
Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
Design and conduct clinical trials according to ICH E8 and E9 guidelines.
Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
Navigate regulatory compliance and inspections related to clinical trials.
https://www.udemy.com/course/good-clinical-practices-gcp/?couponCode=CRMGCP
Enjoy!
Adhere to ICH GCP Guidelines for Ethical and Rigorous Clinical Trials
New
Rating: 0.0 out of 5
(0 ratings)
288 students
1.5 hours on-demand video
Course Description
This comprehensive Good Clinical Practices (GCP) course provides a thorough understanding of the ethical and regulatory principles governing clinical trials. It delves into the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, ensuring you grasp the essential standards for conducting clinical research.
Course Objectives
By the end of this course, you will be able to:
Articulate the definition, purpose, and historical context of GCP.
Explain the importance of GCP in protecting human subjects and ensuring data integrity.
Identify key international organizations involved in establishing GCP standards.
Apply ethical principles and informed consent procedures in clinical research.
Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
Design and conduct clinical trials according to ICH E8 and E9 guidelines.
Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
Navigate regulatory compliance and inspections related to clinical trials.
https://www.udemy.com/course/good-clinical-practices-gcp/?couponCode=CRMGCP
Enjoy!