13 principles of ICH GCP - Good Clinical Practices Guidelines in Clinical Research #gcp #ich

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ICH - Good Clinical Practices play critical role in conducting clinical trials in ethical and scientifically sound manner. These guidelines are crucial to understand as it lays fundamentals of clinical research methodology and global ethical and scientific quality standards.


Link to the important videos:

Nuremberg Code:    • Nuremberg Code and Nazi doctor trials -   ...  
Thalidomide Tragedy:    • The Thalodomide Tragedy - Clinical Researc...  
Tuskegee Syphilis Study:    • Tuskegee Syphilis Study & Belmont Report -...  
Phases of Clinical trials:    • What are Phase trials? - Explaining all Ph...  
Good Clinical Practices (ICH-GCP):    • Good Clinical Practices (GCP) and 13 Princ...  
Ethics Committee in Clinical Research:    • Ethics committee in Clinical Research  
NDCT Rules 2019:    • New Drugs and Clinical Trials Rules, 2019 ...  
SAE reporting and SUGAM:    • Serious Adverse events & SAE reporting - W...  
Adverse events (AE) in Clinical Trials:    • Adverse Events & Adverse Drug reactions in...  


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In this video we talk about:
(0:00) Intro
(0:37) What is ICH - Good Clinical Practices (GCP)
(2:30) Principle 1 - Ethics in Clinical Trials
(3:49) Principle 2 - Risk vs Benefits of Clinical Trials
(4:58) Principle 3 - Trial participants and Safety
(5:56) Principle 4 - Information on Medicinal Products
(7:04) Principle 5 - Good Quality Trials
(7:44) Principle 6 - Compliance with Study Protocol
(8:58) Principle 7 - Medical Decision and Responsibilities
(9:34) Principle 8 - Trial staff competency
(10:15) Principle 9 - Informed consent in Clinical Trials
(11:04) Principle 10 - Clinical Trial Data
(11:42) Principle 11 - Confidentiality in Clinical Trials
(12:36) Principle 12 - Good manufacturing Practices
(13:17) Principle 13 - Quality Assurance in Clinical Trials
(14:23) Advanced certification in Clinical Research


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