Learning Objectives:
To equip clinical research professionals with the knowledge and skills necessary to conduct clinical trials in compliance with ICH E6(R3) guidelines, ensuring data integrity, participant safety, and ethical conduct.
Targeted Trainees:
- Pharmaceutical industrial
- Investigators
- Study Coordinators
- Data Managers
- Ethics Committee Members
- Sponsor Representatives / CROs
- Monitors (CRAs)
Trainer’s;
- Dr. Rania Ibrahim Shousha – Manager of Protocols and Clinical Studies Follow-up Administration
- Dr. Dalia Kamal – Manager of the Pharmaceutical Protocols Unit at Protocols and Clinical Studies Follow-up Administration
Program Agenda
Day 1: Introduction to ICH E6(R3) and GCP Principles
Objectives:
Understand the historical context and purpose of ICH GCP.
Identify the core principles of GCP and their importance.
Define the roles and responsibilities of key stakeholders in clinical trials.
Day 2: Sponsor Responsibilities, Monitoring, and Quality Management
Adverse Event Reporting & Safety Assessment in Clinical Trials: Regulatory Requirements and Best Practices
Objectives:
- Describe the responsibilities of sponsors in ensuring the quality and integrity of clinical trials.
- Understand the importance of monitoring and quality management in clinical research.
- Explain the concept of risk-based monitoring and its implementation.
- Apply principles of data integrity and data quality in clinical trials.
- Describe the requirements for computerized systems used in clinical research.
- Understand the process of adverse event reporting and management.
Day 3: IRB/IEC, Investigator Responsibilities and Essential Documents
Data Management, and Computerized Systems
Objectives:
- Explain the role and function of IRB/IEC in protecting the rights and welfare of trial participants.
- Describe the responsibilities of investigators in conducting ethical and compliant clinical trials.
- Identify essential documents required for clinical trials and their significance.
- Apply principles of data integrity and data quality in clinical trials.
- Describe the requirements for computerized systems used in clinical research.
- Understand the process of adverse event reporting and management.
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