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Courses related to quality assurance of clinical research at ̽»¨¾«Ñ¡

If clinical research is part of your doctoral education (you handle sensitive personal data), you must pass courses in quality assurance/Good Clinical Practice, at half time review, 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).

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.