Good Clinical Practice ICH GCP - Full Certificate Course

About this course

Title: Good Clinical Practice ICH GCP - Full Certificate CourseMaster the Principles of Ethical Clinical Research.Are you looking to establish a strong foundation in clinical research ethics and compliance? Enroll in our comprehensive "Good Clinical Practice ICH GCP - Full Certificate Course" to gain an in-depth understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) guidelines.Key Highlights:Essential ICH-GCP Principles: Dive into the core principles of ICH-GCP, including the protection of human subjects, data integrity, and the ethical conduct of clinical trials. Understand the requirements for conducting clinical research that is accepted globally.Roles and Responsibilities of IRB/IEC: Gain insights on Roles and Responsibilities of IRB/IEC, their Composition, Functions and Operations, Procedures, Records, Submission and Communication.Roles and Responsibilities of Investigator: Understand Roles and Responsibilities of an Investigator, Protocol compliance, Premature suspension of trial, Medical care, Safety Reporting, Informed consent & End of Participation, Investigational product management, Randomization & Unblinding.Roles and Responsibilities of Sponsor: Understand Roles and Responsibilities of a Sponsor, Communication with IRB/IEC and Sponsor oversight, Quality management, Non-compliance, safety assessment & reporting, Investigational products, Data/ Records and Clinical study report.Investigator's Brochure: Development of the Investigator’s Brochure, Reference Safety Information and Risk-Benefit Assessment, General considerations and Contents of the Investigator’s Brochure.Clinical Trial Protocol and its Amendment:

Course objectives

• Establish a foundation in clinical research ethics
• Explain the ethical conduct required in clinical trials
• Describe the communication protocols between IRB/IEC and sponsors