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Good Clinical Practice (GCP)
Good Clinical Practice (GCP)
Curriculum
6 Sections
20 Lessons
10 Weeks
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Module 1: Introduction to Clinical Research and GCP
4
1.0
Chapter 1: The History and Significance of Clinical Research – Dive into the pivotal milestones and key figures that have shaped modern clinical trials and explore the evolution of ethical standards in research.
1.1
Chapter 2: Introduction to Good Clinical Practice – Understand the origin, development, and key principles of GCP alongside the crucial roles of regulatory bodies such as the FDA and EMA.
1.2
Chapter 3: Ethics in Clinical Research – Delve into the ethical considerations, the informed consent process, and the vital role of ethics committees.
1.3
🎦
Module 2: The Protocol and Regulatory Framework
4
2.0
Chapter 1: Designing a Study Protocol – Learn to craft clear and detailed study protocols, and manage amendments and deviations.
2.1
Chapter 2: Regulatory Compliance in Clinical Trials – Gain insights into global regulatory requirements and the intricacies of submission and approval processes.
2.2
Chapter 3: Documentation and Records Management – Master the art of managing essential documents and understanding Good Documentation Practices (GDP).
2.3
🎦
Module 3: Roles and Responsibilities
4
3.0
Chapter 1: Investigator Responsibilities – Explore the extensive responsibilities of the investigator to the sponsor and monitor, ensuring a comprehensive grasp of each pivotal role within a trial.
3.1
Chapter 2: Sponsor Responsibilities – Understand the critical responsibilities of the sponsor, including overseeing the overall conduct of the clinical trial, ensuring compliance with regulatory requirements, and managing financing and communication among all stakeholders.
3.2
Chapter 3: Monitor’s Role and Site Management – Explore the essential functions of a clinical trial monitor, focusing on on-site management, adherence to study protocols, and the assurance of participant safety throughout the trial process.
3.3
🎦
Module 4: Conducting the Trial
4
4.0
Chapter 1: Participant Recruitment and Management – From participant recruitment and data management to safety monitoring, understand every step with practical insights and strategies.
4.1
Chapter 2: Data Management in Clinical Trials – Learn the fundamentals of data management in clinical trials, including data collection, processing, and storage, to ensure accuracy, reliability, and statutory compliance.
4.2
Chapter 3: Safety Monitoring and Adverse Events – Delve into the procedures for monitoring participant safety and managing adverse events, ensuring immediate response strategies and compliance with ethical standards.
4.3
🎦
Module 5: Audit, Inspection, and Quality Assurance
4
5.0
Chapter 1: Preparing for Audits and Inspections – Learn how to prepare for audits, ensure continuous quality improvement, and close out trials with precision and integrity.
5.1
Chapter 2: Quality Assurance in Clinical Trials – Gain insights into the quality assurance processes that ensure the integrity of clinical trial data and compliance with global regulatory standards.
5.2
Chapter 3: Closing the Trial – Discover the comprehensive steps required to successfully close a clinical trial, including data analysis, reporting results, and post-study follow-ups.
5.3
🎦
Quiz
1
6.1
Good Clinical Practice (GCP): Quiz
13 Questions
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