Quality Assurance Applied to Clinical Research

Third-cycle level | 1.5 credits (HEC) | Course code: H5F6083
VT 2026
Study period: 2026-02-09 - 2026-02-22
LANGUAGE OF INSTRUCTION: The course is given in English
Application period: 2025-10-15 - 2025-11-05
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Course description

This comprehensive 1.5-credit online course is designed for doctoral students and postdoctoral researchers who want to master the essential principles of clinical research excellence. You will gain critical expertise in Good Clinical Practice (GCP), ethical frameworks, regulatory compliance (including GDPR), and robust data management strategies that ensure research integrity and participant safety.

The flexible format features interactive video lectures, real-world case studies, and peer review assignments that provide practical skills applicable to interventional studies, observational research, and registry-based studies. Upon completion, you will be equipped to design and conduct clinical research meeting international standards while navigating complex regulatory requirements with confidence.

Prerequisites and Selection

Prerequisite courses, or equivalent

No prerequisite courses, or equivalent, demanded for this course.

Selection

Selection will be based on:  
1) the relevance of the course syllabus for the applicant’s individual study plan/research (according to written motivation). 
2) start date of doctoral studies (priority given to earlier start date). 

Course director

Helene Rundqvist

Course syllabus

H5F6083

Department

Department of Laboratory Medicine

Doctoral programme

**Not within a doctoral programme

Type of course

Quality Assurance of Clinical Research

Keywords

human research, clinical trial, distance

CONTACTRodrigo Fernandez Gonzalo

rodrigo.fernandez-gonzalo@ki.se