Anonymous

The course provided me with answers regarding the flow of work regarding obtaining the approval in EU. What type of clinical trials require what kind of documents. Another important point that I noted for myself is clear role and responsibility of stakeholders on different approval of documents such as the adverse events reporting, annual reports, archive of clinical trials closed, data locking and report on the study. Having my internship at the hospital where the clinical trial is conducted, what interested me the most is the clear delivery of the content of clinical trial to patients who are offered to participate on the trial. Another important point to note, is the regulation regarding medication and medical devices testing in EU from outside the zone EU. I was mostly positive about the comprehended and organized delivery of long principles of each document such as Nuremburg code, Declaration of Helsinki, GCP ISH and the role of national authorities regarding the guidelines provided by EU. I find the provided course extremely helpful for people who are already in the environment where the clinical trials are conducted. Sometimes with all the loads of work and information there is no time to separate who is the main responsible for each action and what is the history behind. The course provides clear explanation and view on each step of clinical trial conduct and stakeholders responsibility.