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CLINICAL RESEARCH

CLINICAL RESEARCH

Module 1 1. Introduction to Clinical Research and Drug Development
Unit 1 1. What is Clinical Research (CR) and its significance(CR)
Unit 2 1.2 Phases of Drug Development (Pre-clinical to Post-marketing)(CR)
Unit 3 1.3 Types of Clinical Trials (Interventional vs. Observational)(CR)
Unit 4 1.4 Key stakeholders in CR Sponsor, CRO, Investigator, IRBIEC, Regulatory Authorities(CR)
Module 2 2. Overview of ICH GCP E6 (R3) & Quality Systems
Unit 1 2.1 History and purpose of ICH GCP
Unit 2 2.2 The Core Principles of ICH E6(R3)
Unit 3 2.3. Quality_by_Design
Unit 4 2.4 QMS_in_Clinical_Trials
Unit 5 2.5 Training requirements and documentation within a QMS
Module 3 3.Good Clinical Practice (GCP) Principles
Unit 1 3.1 Ethical Principles (Belmont Report, Declaration of Helsinki).
Unit 2 3.2 Principles of GCP Data integrity, records retention, proportionate procedures
Unit 3 3.3 Trial Processes and Measures being Proportionate to Risk.-Risk-Proportionate_Trials
Unit 4 3.4 Essential Documents for the Conduct of a Trial
Module 4 4. Clinical Trials Protocol, Design, and Methodology
Unit 1 4.1 Clinical Trials Protocol, Design, and Methodology
Unit 2 4.2 The Clinical Trial Protocol Components and Amendments
Unit 3 4.3 Trial Designs Parallel, Crossover, Factorial
Unit 4 4.4 Adaptive Clinical Trial Designs Concepts, Advantages, Challenges
Unit 5 4.5 Blinding and Randomization
Module 5 5. Institutional Review Board (IRB) & Independent Ethics Committee (IEC)
Unit 1 5.1 Purpose, Composition, and Authority of the IRB & IEC
Unit 2 5.2 Types of Review (Full, Expedited, Exemption)
Unit 3 5.3 Continuing Review and Reporting Requirements
Module 6 6. The Investigator's Responsibilities to the IRB/IEC
Unit 1 6.1 Investigator's Role and Responsibilities
Unit 2 6.2 Communication with the IRB_IEC
Unit 3 6.3 Global Regulatory Bodies
Module 7 7.Investigator Responsibilities in Clinical Trials
There are no units in this module.