Description

The Clinical Research Master Class is a four-month online intensive program enriched with practicals, workshops, and scenario-based modules. It offers a holistic view of the clinical trials process, from the project development plan to the final study report and an introduction to marketing authorisation. Our course structure follows an implementation of a protocol; every subject is aligned to the protocol and project deliverables. We teach the learners how to conduct clinical trials and how each role “works” to deliver clinical trial data efficiently, with quality, and as per regulatory requirements.

In our four-month Clinical Research Master Class, we offer a comprehensive program covering key aspects of clinical trial management:

Planning and Design: Learn the processes involved in protocol development, Investigator’s Brochure (IB) creation, and essential document preparation.

Site Setup: Understand the requirements for establishing a research site and engage in relevant setup activities.

Project Management: Dive into the fundamentals of project management as it applies to clinical trials. Explore the project management framework and gain insights into clinical project management, including protocol implementation and the roles and responsibilities of clinical project managers.

Regulatory & Ethics Committee (EC): Get hands-on experience with regulatory and ethics committee application processes. Learn how to handle various applications and navigate the regulatory landscape.

Site Management: Explore the daily activities of Clinical Research Associates (CRAs), monitors, and site managers. From site initiation to an approved Monitoring Visit Report (MVR), gain operational skills that set you apart in your role, whether as a CRA or in another clinical trial-related position.

Clinical Trial Operations: Gain a deep understanding of how research sites operate, from patient enrollment to protocol-specific functions. This module is essential for individuals from various roles within clinical trial delivery, as it sheds light on on-site operations.

Trial Closure and Documentation Management: Learn about the process of closing a trial and effectively managing study documents.

Our Clinical Research Master Class is ideal for investigators, CRAs, those considering a career in the industry, regulators, and ethics committee members. Join us for this four-month course to enhance your operational knowledge in clinical trial implementation, setup, conduct, and management.