4.75
(4 Ratings)

Clinical Research Master Class

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About Course

INTRODUCING

A comprehensive and dynamic online training program designed to equip learners with the essential skills and knowledge required to excel in clinical research.
Our course is meticulously structured to guide you through the intricate process of conducting clinical trials, ensuring you gain a solid foundation and practical expertise.

Clinical Research Master Class:
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, how each role “work” to deliver clinical trial data, in an efficient, quality and as per regulatory requirements. We aim to immerse participants in a rich learning experience that seamlessly blends theoretical insights with hands-on workshop activities, preparing them for real-world applications in the clinical research domain.
Time Requirement for Clinical Research Masterclass
To fully benefit from the course and apply all the learning, the candidate must commit to 4- monthly schedule which will allow them to complete all work packages.

Who Qualifies
The training is designed for all roles, including investigators, study coordinators, CRAs, and regulatory and other service Providers in clinical research operations.
Good Clinical Practice (GCP)

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Course Content

Design and planning of a clinical trial
As you embark on Module 1 of the Clinical Research Master Class, focusing on the design and planning of clinical trials, you'll gain a comprehensive understanding of the intricate processes involved in clinical research. In the first two weeks, you'll explore the strategic aspects of clinical development, delve into the basics of research methodology, and learn how to craft robust protocols and investigator brochures. Your journey will commence with learning the Clinical Development Strategy, where you'll uncover how pharmaceutical companies and research organizations chart the course from drug discovery to market. You'll then move on to the essentials of Research Methodology, acquiring hands-on knowledge of the research framework, from problem definition to ethical considerations and data collection techniques. As you progress, you'll gain insights into the development of protocols and investigator's brochures, learning how to summarize study details effectively and define clear study objectives. You'll also scrutinize various study designs and learn to identify appropriate assessments and procedures for clinical trials. Throughout this module, you'll be guided by the case study of Candy001, a treatment for diabetes undergoing a Phase III trial, which will serve as a practical example to apply your newfound knowledge. By the end of this module, you will be well-equipped with the foundational skills to excel in the field of clinical research and make a meaningful impact on global health initiatives. Prepare to immerse yourself in the world of clinical trials, where your expertise will begin to blossom.

  • Lesson 1 expectations and assignments
    07:40
  • Basics of Research Methodology Part 1 of 2
    48:00
  • Basics of Research Methodology Part 2 of 2
    46:00
  • Clinical Development Strategy
    43:05
  • Protocol and Investigational Product Brochure
    48:13

Project Management Fundamentals
Project management is a critical discipline that provides a structured framework to guide a project from inception to completion, ensuring goals are met while adhering to predetermined constraints such as cost, schedule, quality, and resource availability. In the context of clinical projects, this discipline takes on additional significance due to the complexity of balancing technological demands with the human resources required to not only finish the project but also ensure patient safety during clinical trials. Clinical trials are intensive projects that necessitate meticulous planning and execution. They involve a range of specialized individuals working together to achieve a common goal within a specified timeframe. The duration of these research endeavors can vary greatly, from several months to over a decade, yet the principles of project management remain consistent and are pivotal for success. Effective clinical research project management is essential for ensuring that the research is conducted within the allotted time, budget, and technological constraints, all while complying with strict regulatory requirements. The project manager's role encompasses planning, budgeting, prioritizing, and controlling the project to release a clinical trial product that meets all necessary standards and regulations. The masterclass in project management fundamentals is designed to equip participants with the necessary skills to manage such intricate projects successfully. The course covers key areas of project management including: Project Integration: Ensuring that project processes work together seamlessly. Scope Management: Defining and controlling what is and is not included in the project. Time Management: Planning the timeline and ensuring the project stays on schedule. Cost Management: Estimating costs and controlling the budget. Quality Management: Ensuring that the project meets the defined quality standards. Human Resource Management: Organizing, managing, and leading the project team. Communication and Stakeholder Management: Managing communications and engaging with stakeholders effectively. Risk Management: Identifying, analyzing, and responding to project risks. Procurement: Acquiring goods and services from external sources. By mastering these fundamentals, project managers in the clinical research field can facilitate the smooth execution of trials,

Clinical Project Management

Quality Management

Site Set-up, Feasibility and Selection

Clinical Trial Regulatory Submission_SAHPRA

Ethics Application Process -South Africa

Conducting Site Initiation and Activation

Clinical Study Conduct

Clinical Study Monitoring

Clinical study close-out

Student Ratings & Reviews

4.8
Total 4 Ratings
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MC
4 weeks ago
Very exciting and informative, extra resources are really are helpful.
undertaking this masters program has been both incredibly challenging and deeply rewarding experience from the very beginning the workload was intense with complex topics requiring sufficient effort to grasp fully , high group work expectation kept me on my toes pushing me to develop good time management and critical thinking skills,despite the stress thev course is informative and comprehensive ,practical prepared me for real life world settings,the passion of the coordinator shines through in every lecture and assignment ,all experts brought to engage in each module very informative
there were moments of reflection and introspection during the course
moments of self doubt especially during high pressure deadlines but these challenges ultimately contributed to my personal growth ive come out stronger and ready to work,knowledgeble
Ashley Matlou
1 month ago
This is definitely the MBA of clinical research. Highly recommend it to everyone who wants to break into or gain more knowledge about the clinical research industry, it is structured to cater for everyone, you can watch recordings at your own time in the dashboard .The masterclass will equip you with necessary knowledge, skills and practical experiences.
NS
8 months ago
Hello.

Content and offering industry aligned
Like the questions raised by the moderators during the chapters
Kindly improve the audio in the last 2 modules
Couldnt see any quizzes and/or excercise or assignments,are they sent separately?
I enjoyed the offering its like experiential learning.

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