Clinical research is necessary to establish the safety and effectiveness of specific health and medical products and practices. Much of what is known today about the safety and efficacy of specific products and treatments has come from randomized controlled clinical trials that are designed to answer important scientific and health care questions. Randomized controlled trials form the foundation for “evidence-based medicine”, but such research can be relied upon only if it is conducted according to principles and standards collectively referred to as “Good Clinical Research Practice” (GCP).

Before medical products can be introduced onto the market or into public health programmes, they must undergo a series of investigations designed to evaluate safety and efficacy within the parameters of toxicity, potency, dose finding, and field conditions. Full information must be documented on therapeutic indications, method of administration and dosage, contraindications, warnings, safety measures, precautions, interactions, effects in target populations and safety information.

The conduct of clinical research in accordance with the principles of GCP helps to ensure that clinical research participants are not exposed to undue risk, and that data generated from the research are valid and accurate. By providing a basis both for the scientific and ethical integrity of research involving human subjects and for generating valid observations and sound documentation of the findings, GCP not only serves the interests of the parties actively involved in the research process, but also protects the rights, safety and wellbeing of subjects and ensures that investigations are scientifically sound and advance public health goals.

We invite you to learn within a sophisticated interactive simulation of clinical trial. For 24 weeks, you will work virtually through different aspects of the clinical trial inspection. The authentic tasks we offer take place at all aspects of clinical trial, including GCP principles, quality management system, risk based thinking, preparing for an inspection, inspection, and reporting. These tasks are arranged mainly as group activities. You’ll benefit a lot from this collaborative learning. We offer you the tools to easily connect with other participants so you can discuss and work together as a team. You will be able to work with a real clinical trial protocol (but modified for learning purposes). Within this unique learning environment we assess our learning by self, peer, and expert reviews. There will be no tick the right answer type tests.

Most importantly, nobody will lecture you in our course… but we’ll make available to you all the resources that have been specifically produced for this course, including the video and document library.

Mentors will provide timely feedback to you whenever necessary and be there to assist you.
Don’t wait any longer.
Just click on the online application.
Hope to see you on board.