Diploma in Good Clinical Practices

Xpert Learning

Reed Courses Certificate of Completion

Digital certificate - Included

• Diploma in Good Clinical Practices 1:34:08

  • 1: module_01_introduction_to_good_clinical_practice_(gcp)_and_ich_guidelines (1080p 13:41
  • 2: module_02_ethical_principles,_informed_consent,_and_ich_e6(r2) (1080p) 15:30
  • 3: module_03_designing_and_conducting_clinical_trials_with_ich_e8_and_e9 (1080p) 17:42
  • 4: module_04_data_management_and_reporting_with_ich_e6(r2) (1080p) 16:48
  • 5: module_05_safety_and_monitoring_in_clinical_trials_with_ich_e6(r2)_and_e6(r3) (1 16:27
  • 6: module_06_regulatory_compliance,_inspections,_and_ich_e6(r3) (1080p) 14:00

The course is structured into six modules, each delving into specific aspects of GCP:

• Module 1: Introduction to Good Clinical Practice (GCP) and ICH Guidelines This module lays the foundation for understanding GCP by defining its purpose, historical context, and key international organizations involved in its development. Learners will also explore the importance of GCP in protecting human subjects and ensuring data integrity.
• Module 2: Ethical Principles, Informed Consent, and ICH E6(R2) This module focuses on the ethical considerations and legal requirements surrounding clinical research. Learners will study the Declaration of Helsinki, informed consent processes, and special considerations for vulnerable populations. The module also delves into the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
• Module 3: Designing and Conducting Clinical Trials with ICH E8 and E9 This module explores the practical aspects of clinical trial design and execution. Topics covered include protocol development, randomization, blinding, monitoring, investigator responsibilities, and Institutional Review Board (IRB) approval. The module also discusses the ICH E8 and E9 guidelines on General Considerations for Clinical Trials and Statistical Principles for Clinical Trials.
• Module 4: Data Management and Reporting with ICH E6(R2) This module focuses on the efficient and accurate management of clinical trial data. Learners will learn about data collection, handling, storage, case report form (CRF) development, adverse event reporting, interim analyses, and clinical trial documentation. The module also covers the relevant ICH E6(R2) guidelines.
• Module 5: Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3) This module addresses the critical aspect of ensuring participant safety throughout clinical trials. Topics include risk management, safety reporting, Data Monitoring Committee (DMC) responsibilities, handling protocol deviations, and the ICH E6(R2) and E6(R3) guidelines.
• Module 6: Regulatory Compliance, Inspections, and ICH E6(R3) This module explores the regulatory landscape of clinical research. Learners will learn about the role of regulatory authorities, GCP inspections, audit readiness, consequences of non-compliance, and continuous improvement. The module also discusses the ICH E6(R3) guidelines.

Disclaimer: This course provides a theoretical knowledge of Good Clinical Practices (GCP) and does not qualify a person for practical application in clinical research. Practical experience and adherence to specific regulatory requirements are essential for working in this field.

• Researchers
• Clinical research coordinators
• Data managers
• Regulatory affairs professionals
• Medical professionals
• Students pursuing careers in clinical research

No prior experience in clinical research is necessary. However, a basic understanding of medical terminology and research methodology would be beneficial.

• Clinical Research: Research associate, coordinator, monitor, or project manager.
• Regulatory Affairs: Regulatory affairs specialist or associate.
• Data Management: Data manager or analyst.
• Quality Assurance: Quality assurance specialist or auditor.
• Academia: Researcher or professor in clinical research.

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