790365 Clinical studies

Type: Lecture and seminar
Semester hours: 1
Lecturer (assistant): Schwarzer-Daum, Brigitte , Pleiner-Duxneuner, Johannes
Organisation
Offered in: Wintersemester 2023/24
Languages of instruction: Englisch
Content: THIS COURSE IS HELD IN COOPERATION WITH THE MEDICAL UNIVERSITY VIENNA (MUW). REGISTRATION AND ISSUE OF CERTIFICATES IS DONE BY THE MUW. THE CERTIFICATES WILL THEN BE RECOGNIZED AT THE BOKU.

PLEASE BE SURE TO CO-REGISTRATE AT THE MUW IN TIME!

Clinical Trials and Drug Development
From "First in Man" to "First on the Market"

Modul 1
Why do we need clinical trials?
Study-Design and Methodology
Randomisation Stratification..
Different study types
Choice of Comparator
Placebo and Assay Sensitivity
Precision, Accuracy, Bias, Confounder

Modul 2
Phases of Clinical Research
Surrogate versus Clinical Endpoint
Good Clinical Practice Guidelines
Data-Handling Adverse Events

Modul 3
Ethics committee
Study protocol
Inclusion Exclusion Criteria
Case Record Forms
Life cycle of a drug

Modul 4
Ethics of clinical research
Historic background,
Patient protection - Declaration of Helsinki,
Patient Information and Informed consent
European Medicine Agency - Centralized Marketing Authorisation
Research Misconduct and Fraud
Objective (expected results of study and acquired competences): Master Biotechnology - Specialization in Medical Biotechnology

You can find more details like the schedule or information about exams on the course-page in BOKUonline.