För studenter på kursen Quality Assurance in Clinical Research kurskod 2F2873

This course provides the participant with the knowledge needed to secure the quality in clinical research. Regardless of your research area, you will after this course understand how to protect patient's safety, and how to create trustful data. The course starts with a mandatory introduction meeting (Zoom) followed by digital training modules including group work, discussion and webinars. Those who have completed the course, a course certificate and ICH-GCP Diploma will be provided.

Kursplan

Four pillars
Five pillars to secure research quality

Course objectives:

On completion of the course, the student should be able to:

Knowledge and understanding

  • Develop understanding of how to document data which can recreate all moments in a clinical research process in a secured way.
  • Internalised the meaning of the Helsinki Declaration and Good Clinical Practice so that research subjects’ autonomy and integrity always remain the first priority.
  • have knowledge on Swedish legislations as well as European and international legislations, and identify which authority, and the way to apply for the research projects .

Skills and abilities

  • identify different responsibilities the investigator, study team members and sponsor have in the clinical trial.
  • generate audit trail to secure all moments in a clinical research process can be recreated.
  • conduct one’s research with placing research subjects’ autonomy and integrity always remain the first priority.
  • summarise a project proposal into a synopsis and based on that make a risk-benefit analysis of the project

Judgement and approach

  • demonstrate judging project proposals from the patient perspective by scientific and sound ethical approach.
  • search for, collect, evaluate, interpret and discuss (in both written and oral forms) information regarding quality assurance of clinical research.

Course Evaluations

Contacts

Pierre Lafolie

Course Director
Malmström R

Mari Liljefors

Course Coordinator/Facilitator
Administration