Course description
The goal of this course is to provide an introduction to quality assurance practices in public health intervention studies as well as observational studies within medical sciences and public health research. This course will provide you with the basic knowledge and skills necessary to carry out human subjects research studies in compliance with relevant regulations and standards of the fields.
We will discuss general practices and principles, as well as learn about tools available to KI students and researchers. The purpose is also to help you apply key skills that you will need throughout your career, such as research planning and documentation.
This course is targeted for human subjects researchers working with personal data derived from epidemiological cohorts, healthcare records, administrative registers, or qualitative studies, as well as those carrying out public health intervention or implementation studies.
We review the principles of Good Clinical Practice and discuss how some principles can be adapted to contexts outside of randomized clinical trials; discuss key regulations such as GDPR and understand how they influence our everyday work as researchers; and learn about the quality assurance measures throughout the entire lifecycle of a study, from planning to publication. We cover tools available at KI, such as the Electronic Lab Notebook (ELN), and the rules governing documentation for KI researchers.
The course takes place online, with a single optional in-person workshop for hands-on practice with ELN. This course uses a blended learning approach, relying on online activities (including recorded lectures, quizzes, and discussion boards), self-directed learning, and live group discussions (online) focusing on concrete applications of quality assurance principals in different kinds of studies.
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 doctoral project (according to written motivation), 2) start date of doctoral studies (priority given to earlier start date).
The written motivation does not need to be long. Please simply indicate if a course in "Quality Assurance of Clinical Research" is obligatory or recommended for you, based on whether one or more of the studies included in your individual study plan (ISP) meet the criteria specifed under Section 3.1 of the "General syllabus for third-cycle/doctoral education in the subject of Medical Science" for conducting ‘clinical research’. Keep in mind that the definition of ‘clinical research’ is broad.
From Section 3.1: 'A course in "Quality Assurance of Clinical Research" is obligatory for doctoral students whose research includes:
-intervention studies with physical and/or psychological effect, or
-sensitive personal data that is directly identifiable or is traceable to a living individual (pseudonymized), for example via a code list. The location of the code list and whether the doctoral student has access to the code list or not is irrelevant.
For students conducting research on human biological material only, this course is recommended but not obligatory. '
Course director
Renee Gardner, renee.gardner@ki.se
Course syllabus
K9F5743
Department
Department of Global Public Health
Doctoral programme
Public Health Science (PHSP)
Type of course
**Other course
Keywords
quality assurance, GDPR, documentation, protocols