PBF356 – Clinical Trials and Documentation of Drugs
Schedule, syllabus and examination date
Course content
The course comprises theory and practice of clinical drug trials, the significance of the results for the choice of drugs and requirements for clinical documentation. The course covers a presentation and study of trial phases, trial methodology, evaluation of results, statistical consideration, quality assurance, ethics and other topics. Furthermore, the students will work with scientific and regulatory demands to clinical documentation and use of clinical documentation to drugs in practice.
Learning outcome
After the course the students will have the necessary knowledge and understanding of how to plan, conduct and report clinical trials and to be able to critically perform quality assessment of trials. Furthermore, the student shall be capable of selecting drugs based on reported clinical drug trials.
Admission
Students who are admitted to study programmes at UiO must each semester register which courses and exams they wish to sign up for in Studentweb.
If you are not already enrolled as a student at UiO, please see our information about admission requirements and procedures.
Prerequisites
Formal prerequisite knowledge
All courses of the first period or equivalent relevant courses.
Recommended previous knowledge
All previous courses
Teaching
Lectures: Lectures and seminars, Study groups: Study groups with cases, Labwork: None
Examination
Oral examination in addition to a written project.