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| Semester | fall semester 2020 |
| Course frequency | Every fall sem. |
| Lecturers | Christian Burri (christian.burri@unibas.ch, Assessor) |
| Content | Compact two day introductory course to the Good Clinical Practice guideline (GCP) designed according to the requirements of Swissethics (level of investigators and sub-investigators). The course provides a compact insight into the ICH E6 GCP regulation and related topics. It is ideal for Investigators, study personnel and people involved and/or interested in clinical research. It serves as beginners as well as refresher training. Content: Principles of the ICH-GCP guideline and its historical background; Legal and regulatory requirements of clinical research; Role of ethics committees and regulatory authorities; Quality and data management in clinical trials; Study documentation, incl. structure and content of study protocol; Study design and basic statistical principles. |
| Learning objectives | Understanding the basic principles of research involving humans Knowing the fundamental principles of Good Clinical Practice |
| Bibliography | Mandatory reading: Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Version 2015 (http://www.wma.net/en/30publications/10policies/b3/) Optional reading: Guideline ICH E6 Good Clinical Practice (http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html) |
| Comments | A certificate of participation will be handed out Film and sound recordings during the course are strictly forbidden (recorders may be confiscated) |
| Course application | The seminar is fully booked! |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Interval | Weekday | Time | Room |
|---|
No dates available. Please contact the lecturer.
| Modules |
Module: Clinical Drug Development: the Basis for Market Approval (Master's Studies: Drug Sciences) |
| Assessment format | continuous assessment |
| Assessment details | Complete participation and 70% correct answers at the Multiple choice test (self-checking of acquired knowledge) at the end of the seminar |
| Assessment registration/deregistration | Reg.: course registration, dereg: cancel course registration |
| Repeat examination | no repeat examination |
| Scale | Pass / Fail |
| Repeated registration | as often as necessary |
| Responsible faculty | Faculty of Science, studiendekanat-philnat@unibas.ch |
| Offered by | Departement Pharmazeutische Wissenschaften |