Course Code: CLRE 5505
Academic Year: 2020-2021
In this course, the student acquire the skills for preparing and applying clinical protocols. Students begin to construct effective protocols considering structures, components, and information necessary for its production. Students gain experience in following guidelines for critical appraisal of articles as well as methods for publication of trial results. Students gain expertise in assessing and preparing clinical trial documents such as Case Report Forms, Investigator's Brochures, and the Clinical Reports. Additionally, students learn the importance of accuracy and reliability as well as the responsibilities for creating and managing relevant documents in compliance with relevant standards and guidelines.