Doctoral Education Courses at MMK

Courses related to quality assurance of clinical research at Karolinska Institutet

If clinical research is part of your doctoral education (you handle sensitive personal data), you must pass courses in quality assurance/Good Clinical Practice where the learning outcomes listed below have been achieved:

- Conclude which legislations affects clinical research and how they do it.

- Deduce how clinical research integrity is affected by fabrication, falsification and plagiarism.
- Account for common problems that may arise in clinical research.
- Differentiate the responsibilities between the investigator, the study team members, and the sponsor in a clinical study.
- Analyse the validity of a research project proposal or publication with a risk-benefit analysis.
- Translate general research quality systems into own research area.
- Critically identify good clinical scientific practices and deviations from it in clinical research.
- Judge data validity and their reproducibility.
- Handling bias, sponsorship, and scientific authorship in a paper.

These constitute the learning outcomes for course no 5580 (Quality assurance of clinical research, 1.5 credits) and also correspond to course no 5274 (Introduction to clinical studies: from idea to archiving, 1.5 credits) and course no 2621 (Clinical research and Good Clinical Practice: protocol, informed consent and application in accordance with laws/regulations, 1.5 credits).

Doctoral students can combine courses to cover all the learning outcomes listed above.

Many courses fulfill some of the learning outcomes. This applies, for example, to statistics courses and "Study design in clinical research". Region Stockholm's one-day course in Good Clinical Practice (GCP), only in Swedish, in combination with courses given at clinical graduate schools, covers all learning outcomes.