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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
Unit 1 7.1 Qualifications and Resources of the Investigator Site
Unit 2 7.2 Investigator Oversight and Delegation of Tasks (Delegation Log)
Unit 3 7.3 Informed Consent Process Oversight
Unit 4 7.4 Accountability for Investigational Product (IP)-IP_Accountability
Unit 5 7.5 Compliance with the Protocol and Regulatory Requirements-Compliance_in_Clinical_Trials
Module 8 8.Roles and Responsibilities of Sponsor & Clinical Trial Monitor
Unit 1 8.1 The Sponsor’s Overall Responsibilities
Unit 2 8.2 Risk-Based Quality Management (RBQM)
Unit 3 8.3 The Role of the Clinical Research Associate (CRA)
Unit 4 8.4 Monitoring Types Centralized, On-site, and Remote Monitoring
Unit 5 8.5 Monitoring Plan Components and Requirements
Module 9 9.Informed Consent Process & Patient-Centricity
Unit 1 9.1 Key Elements of a Valid Informed Consent Form (ICF)-english
Unit 2 9.2 The Informed Consent Discussion (The Process, Not Just the Document)
Unit 3 9.3 Special Considerations for Vulnerable Populations
Unit 4 9.4 Electronic Consent (eConsent) and Regulatory Acceptance
Unit 5 9.5 Participant Rights and Withdrawal from the Study
Module 10 10. Safety Reporting: Adverse Events & Pharmacovigilance
Unit 1 10.1 Definitions (AE), (SAE), (ADR)
Unit 2 10.2 Seriousness Criteria and Expectedness
Unit 3 10.3 Immediate Reporting Requirements and Timelines
Unit 4 10.4 Overview of Pharmacovigilance (PV)
Unit 5 10.5 Safety Data Reconciliation
Module 11 11. Site Initiation Visit (SIV) and Essential Documentation
Unit 1 11.1 Purpose and Execution of the Site Initiation Visit (SIV)
Unit 2 11.2 Reviewing the Investigator Site File (ISF) Setup
Unit 3 11.3 Trial Master File (TMF) and Electronic TMF (eTMF) systems
Unit 4 11.4 Regulatory Inspection Readiness in Clinical Trials