The Truth About Clinical Trial Audits Explained | B.Pharma | Biotechnology

Описание: Every medicine we trust today has passed through a rigorous clinical trial process involving human participants. But how do we ensure these trials are ethical, safe, and scientifically credible?

In this video, we break down clinical trial audits—what they are, why they exist, and how they protect patient safety and data integrity. We also explore the historical events that shaped global clinical research regulations, including the Nuremberg Code, the Thalidomide tragedy, and the Declaration of Helsinki.



🔍 What you’ll learn in this video:

Why clinical trials are strictly regulated

Historical events that transformed human research ethics

What clinical trial audits are and why they matter

Objectives of clinical trial audits

Difference between clinical trial monitoring and auditing

Key focus areas of audits (sites, TMF, data, systems)

Types of clinical trial audits: for-cause, inspection-readiness, post-inspection, and follow-up audits

This video is ideal for:

Clinical research professionals

QA & compliance teams

Life sciences students

Anyone exploring careers in clinical trials or regulatory affairs

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00:00 Introduction – Why we trust medicines
01:15 Why clinical trials are regulated
02:30 Ethics in human research
03:20 The Nuremberg Code (1947)
05:40 Lessons from the Nuremberg Trials
06:45 The Thalidomide tragedy
08:30 Declaration of Helsinki (1964)
10:10 What is a clinical trial audit?
11:30 Objectives of clinical trial audits
13:00 Clinical trial audit vs monitoring
15:30 Focus areas of clinical trial audits
18:30 Types of clinical trial audits
21:00 Why clinical trial audits matter
22:00 Conclusion & outro


Clinical trial audits
Clinical trials explained
What is a clinical trial audit
Clinical trial audit vs monitoring
ICH GCP guidelines
Good Clinical Practice (GCP)
Clinical research regulations
Drug development process
Ethics in clinical trials
Human subject protection
Informed consent in clinical trials
Declaration of Helsinki
Nuremberg Code clinical research
Thalidomide tragedy clinical trials
Regulatory compliance in clinical trials
Clinical QA audits
Inspection readiness clinical trials
Trial Master File (TMF)
Clinical data integrity
Pharmaceutical clinical trials
Careers in clinical research
Life sciences education

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#DeclarationOfHelsinki
#NurembergCode
#ThalidomideTragedy
#TrialMasterFile
#InspectionReadiness
#ClinicalDataIntegrity

#ClinicalResearchCareers