GCP Refresher
After initial training in research ethics and GCP has been completed (investigator and/or sponsor – investigator level), the knowledge should be maintained by regular research activities such as conducting clinical trials, being exposed to GCP inspections, attending continuing education related to research or GCP Refresher courses. The ethics committees can request the researcher to re-take a GCP course or to take a GCP Refresher course, if the ethics committees consider the knowledge had not been maintained. Therefore, this course is recommended for all personnel in human research who would like to maintain and update their knowledge on research ethics and GCP.
The course content focusses on the specific requirements in Switzerland and is updated to ICH GCP E6(R3).
Main topics covered during this course will be research ethics, Swiss legal framework, roles and responsibilities, planning and feasibility, essential study documents and essential records, execution of a trial including informed consent, safety processes, oversight and reporting, as well as study closure and recent updates in Swiss clinical research.
| Course language: | English |
| Duration: | 3 h |
| Next Start: | online course, to be completed at every time and at own pace |
Online course that can be completed at your own pace at any time through self-study.
This course consists of four online training modules. At the end of the course, acquired competencies will be checked by an online quiz.
Module 1: «Basic principles of human research»: Description of the different types of human research including the applicable law and regulations in Switzerland
Module 2: «Planning and preparation of studies in human research»: Determination of study feasibility, description of roles and responsibilities, knowledge of essential study documents
Module 3: «Execution of clinical trials and human research projects». Knowledge of how to conduct a clinical trial including informed consent process, safety management and drug accountability
Module 4: «Update and new developments»: Recent updates and cutting-edge topics in human research e.g. ICH GCP E6(R3)
Duration: approx. 3 h
Course language is English.
After successful completion of the online quiz, certificates will be issued electronically.
This course is regarded as a supplement to a swissethics recognised GCP course in order to refresh knowledge on GCP. It is recognised by swissethics and meets the requirements for the «GCP Refresher course». For the certificate to be valid, participants must have a valid certificate of a GCP course on investigator or sponsor-investigator level, e.g. the GCP-Basiskurs or GCP-Aufbaukurs.
This course is open for everyone interested in refreshing their knowledge about regulations and GCP in clinical research.
The course is especially appropriate for people working in clinical research (investigators, sponsor-investigators, study nurses, study coordinators, clinical research associates, study physicians, assistant physicians, etc.) who have already completed a GCP course in the past and would like to refresh their knowledge in research ethics and GCP. The participation in GCP Refresher courses is generally voluntary, but the ethics committees reserve the right to demand the participation to a GCP Refresher course.
Fee CHF 300
Reduced course fee DKF research group members (for details see *)
- *) The Department of Clinical Research (DKF) offers training grants for members of DKF research groups which result in a reduced fee of CHF 150. The reduction will be applied when registering for the programme. Please note, that training grants can only be offered to DKF clinical research group members, who are working at the group leaders’ local study center.
- Moreover, medical students (BSc, MSc and Dr. med. Human Medicine) and PhD students (Biomedical Engineering, Biomedical Ethics, Clinical Research, Nursing Science, Sport Science, Epidemiology & Public Health, Medicines Development, Insurance Medicine) at the Medical Faculty of the University of Basel may attend the course at a reduced course fee of CHF 150.
Organiser
Department of Clinical Research, University of Basel, c/o University Hospital Basel
Director of Studies:
Verena Golz, Scientific Officer Training & Education, Department of Clinical Research (DKF)
Mareike Gräter
Training and Education
Department Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel
mareike.graeter@clutterusb.ch
Tel. +41 61 556 59 76
This course is regarded as a supplement to a swissethics recognised GCP course in order to refresh knowledge on GCP. It is recognised by swissethics and meets the requirements for the «GCP Refresher course». To be valid, participants must have completed a GCP course on investigator or sponsor-investigator level, e.g. the GCP-Basiskurs or GCP-Aufbaukurs.
Course language is English.
After successful completion of the online quiz, certificates will be issued electronically. Please note that the issued certificate will only be valid together with a valid certificate of the level «Investigator».
Please register here.
Medical Faculty of the University of Basel