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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 Naz...
Thalidomide Tragedy: • The Thalodomide Traged...
Tuskegee Syphilis Study: • Tuskegee Syphilis Stud...
Phases of Clinical trials: • What are Phase trials?...
Good Clinical Practices (ICH-GCP): • Good Clinical Practice...
Ethics Committee in Clinical Research: • Ethics committee in Cl...
NDCT Rules 2019: • New Drugs and Clinical...
SAE reporting and SUGAM: • Serious Adverse events...
Adverse events (AE) in Clinical Trials: • Adverse Events & Adver...
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Contact: 83900 88032 / 81778 96079
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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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