This module will teach you how to conduct a quality clinical trial. This module will examine ethics, subject protections, quality management, and governance. You will also learn the procedures supporting good data collection and management, and budgeting practices. We will conclude by discussing issues related to clinical trial failures and the latest decentralized trial approaches.
Module 4
Clinical Trials: From Concept to Clinical Study Report
Who Should Apply?
Professionals working in clinical research roles, including clinical research associates (CRAs), clinical research coordinators (CRCs), and clinical trial managers. It will enhance their understanding of the entire clinical trial process.
Individuals employed in pharmaceutical and biotech companies, especially those involved in drug development, regulatory affairs, and medical affairs, can benefit from this module to gain a comprehensive understanding of clinical trials.
Regulatory affairs professionals responsible for ensuring compliance with regulations and guidelines in clinical trials can improve their knowledge and skills through this module.
Module Benefits
Comprehensive Knowledge – Participants will acquire a thorough understanding of the entire clinical trial process, from conceptualization to the preparation of the Clinical Study Report (CSR).
Ethical Expertise – Gain insights into ethical considerations and principles governing biomedical research, ensuring adherence to ethical standards in clinical trials.
Quality Management – Understand quality management practices, ensuring the collection of high-quality data and the execution of clinical trials to the highest standards.
Site Selection and Management – Learn best practices for selecting and managing clinical trial sites, including conflict resolution strategies.
Practical Application – Apply what you learn directly to real-world clinical trial scenarios, enhancing your ability to contribute effectively in your role.
Prerequisites, Schedule, and Time Commitment
Prerequisites
A computer and reliable internet to access the online classroom
- Proficiency in English: As this module is conducted in English, participants should have a strong command of the English language, both written and spoken, to effectively comprehend and communicate complex clinical trial concepts.
- While not mandatory, a basic understanding of clinical research terminology and concepts will be advantageous. This knowledge will help participants grasp the material more readily.
Expected Commitment
5-12 hours per week
This module consists of:
- An optional one week orientation
- 5 weeks comprised of 10 lessons and 4 live webinars, each lasting approximately 60-90 minutes
- Final week includes the end of module assessment
Timeline
2026 Cohort – May 18 to June 28
- Orientation (optional): May 11 to May 17
- Weeks 1-5: Lessons 1-10, webinars, and student assignments
- Week 6: Assessment
Module Costs
The total tuition for this module is $2500
GMDP Academy’s Faculty
Our programs are taught by world-renowned faculty.