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Course Curriculum

Unit-1 Introduction
1.1 Introduction Clinical Research 00:18:00
1.2 Evoloution of Clinical Research 00:12:00
1.3 Types of Clinical Research 00:09:00
1.4 Phases of Clinical Research 00:16:00
Unit-2 Drug Discovery and Development
2.1 Drug Discovery Introduction and History 00:09:00
2.2 Drug Discovery Process 00:14:00
2.3 Pre-Clinical Studies 00:04:00
Unit-3 IND Application
3.1 Investigational New Drug Application (INDA) 00:07:00
3.2 Types of INDA & Resources of INDA 00:13:00
3.3 Submitting an IND 00:11:00
3.4 Clinical Hold 00:07:00
Unit-4 Clinical Trials
4.1 Clinical Trials- Phases 00:26:00
4.2 Phase II-IV 00:10:00
Unit-5 Stakeholders
5.1 Stakeholders in Clinical Trials 00:14:00
5.2 CRO and RA 00:09:00
5.3 Institutional Review Board 00:04:00
Unit-6 Pharmacokinetics
6.1 Clinical Pharmacology 08:00:00
6.2 PK-PD Relationship 00:10:00
6.3 Bioavailability 00:09:00
6.4 Volume of Distribution (Vd) 00:05:00
6.5 Phases of BioTransformation 00:08:00
Unit-7 Pharmacodynamics
7.1 Pharmacodynamics 00:07:00
7.2 Drug Action & Factors affecting Drug Response 00:08:00
7.3 Dose Response Curve 00:07:00
7.4 Dose Response Functions, Tolerance 00:05:00
Unit-8 Pharmacovigilance
8.1 Pharmacovigilance Introduction 00:17:00
8.2 Pharmacovigilance in India and Terminology 00:10:00
8.3 Pharmacovigilance Process 00:16:00
Unit-9 ICH, GCP
9.1 Good Clinical Practice, ICH 00:09:00
9.2 Sections and Priciples of GCP-ICH guidelines 00:11:00
9.3 GCP Guidelines- India 00:08:00
9.4 Composition of Ethical Committee 00:09:00
Unit-10 Ethical guidelines
10.1 Ethical Guidelines in Clinical Research 00:09:00
10.2 Universal Ethical Requirements 00:10:00
10.3 Historical Guidelines 00:19:00
Unit-11 ICMR, AYUSH, CTRI
11.1 ICMR Introduction 00:09:00
11.2 ICMR Guidelines 00:26:00
11.3 CTRI 00:05:00
11.4 AYUSH and Its Guidelines 00:16:00
Unit-12 Clinical Data Management
12.1 Clinical Data Management (CDM) 00:14:00
12.2 CDM Workflow, Responsibilities of CDM Team 00:13:00
12.3 Study Set Up 00:20:00
12.4 Medical Coding, SAE Reconciliation Quality Check, Database Locking & Advantages of CDM 00:19:00
12.5 Standard Regulations & Guidelines in CDM 00:07:00
12.6 Clinical Data Interchange Standards Consortium 00:07:00
12.7 Collaborative Studies & Quality Analysis , Monitoring 00:14:00
12.8 Data Quality Management (DQM) 00:07:00
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