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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 | ||