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Semester | fall semester 2021 |
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 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/) Optional reading: Guideline ICH E6 Good Clinical Practice (https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice) |
Comments | A certificate of participation will be handed out Film and sound recordings during the course are strictly forbidden (recorders may be confiscated) |
Admission requirements | Preregistration at studienkoordination-pharma@unibas.ch |
Course application | The seminar is FULLY BOOKED. If you have questions please contact studienkoordination-pharma@unibas.ch |
Language of instruction | English |
Use of digital media | No specific media used |
Interval | Weekday | Time | Room |
---|---|---|---|
Block | See individual dates |
Date | Time | Room |
---|---|---|
Thursday 20.01.2022 | 08.00-17.00 | Alte Universität, Hörsaal -101 |
Friday 21.01.2022 | 08.00-17.00 | Alte Universität, Hörsaal -101 |
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 |