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Conference

Module for the Program

Module outline for 1 Day Program

Module 1: Introduction to Good Clinical Practices (GCP)

  • History & Evolution of GCP: Nuremberg Code, Declaration of Helsinki, Belmont Report

  • Importance of GCP in Clinical Research

  • Overview of ICH-GCP (E6 R2)

Module 2: Ethical Considerations & Stakeholder Responsibilities

  • Principles of Ethics in Research & Informed Consent Process

  • Protection of Human Subjects

  • Roles & Responsibilities:

    • Investigators

    • Sponsors

    • Ethics Committees / IRBs

    • Regulatory Authorities (FDA, EMA, CDSCO)

Module 3: Clinical Trial Conduct & Documentation

  • Essential Documents: Investigator Brochure, Protocol, CRFs

  • Source Documents & Data Integrity

  • Protocol Deviations, Amendments & Compliance

Module 4: Safety Reporting & Regulatory Oversight

  • Adverse Event (AE) & Serious Adverse Event (SAE) Reporting

  • Audits & Inspections

  • Regulatory Compliance & Consequences of Non-Compliance

Module 5: Quality & Future Trends in GCP

  • Quality Assurance (QA) & Risk-Based Monitoring

  • Key Changes in ICH E6 (R3)

  • Overview of Digital Trials (DCTs) & Role of AI in GCP

  • Final Q&A and Feedback

Module outline for 2 Day Program

 Module 1 : Introduction to Good Clinical Practices (GCP)

  • Definition and History of GCP

  • Importance of GCP in Clinical Research

  • Evolution of GCP: Nuremberg Code, Declaration of Helsinki, Belmont Report

  • Overview of ICH-GCP (E6 R2)

Module 2: Ethical Considerations in Clinical Research

  • Definition and History of GCP

  • Importance of GCP in Clinical Research

  • Evolution of GCP: Nuremberg Code, Declaration of Helsinki, Belmont Report

  • Overview of ICH-GCP (E6 R2)

Module 3: Key Stakeholders and Their Responsibilities

  • Sponsor Responsibilities

  • Investigator Responsibilities

  • Ethics Committee/IRB Responsibilities

  • Role of Regulatory Authorities (FDA, EMA, CDSCO, etc.)

Module 4: Essential Documents & Clinical Trial Conduct

  • Investigator Brochure

  • Protocol & Protocol Amendments

  • Case Report Forms (CRFs)

  • Source Documents & Data Integrity

Module 5: Regulatory Compliance & Safety Reporting

  • Adverse Event (AE) & Serious Adverse Event (SAE) Reporting

  • Protocol Deviations & Violations

  • Audits & Inspections by Regulatory Agencies

  • Consequences of Non-Compliance

Module 6: Quality Management & Risk-Based Monitoring

  • Importance of Quality Assurance (QA) & Quality Control (QC)

  • Risk-Based Monitoring Strategies

  • Common Audit Findings & How to Avoid Them

Module 7: Updates in GCP – ICH E6 (R3) and Future Trends

  • Key Changes in ICH E6 (R3)

  • Digital & Decentralized Clinical Trials (DCTs)

  • Role of AI & Technology in GCP Compliance

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