GCP-Refresher
Short Course

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.

This course consists of four online training modules. At the end of the course, acquired competencies will be checked by an online quiz.

Learning module 1: «Basic principles of human research»: Description of the different types of human research including the applicable law and regulations in Switzerland

Learning module 2: «Planning and preparation of studies in human research»: Determination of study feasibility, description of roles and responsibilities, knowledge of essential study documents

Learning 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

Learning module 4: «Update and new developments in research involving humans»: Recent updates and cutting-edge topics in human research e.g. implications of the European Medical Device Regulation (MDR)

Duration: approx. 3 h

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.

  • Dr. Verena Golz

Mareike Gräter
Training and Education
Departement of Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel

mareike.graeter@usb.ch
Tel. +41 61 556 59 76
Training and Education Departement of Clinical Research

Available Mon-Thu 08.30h - 13.30h

CHF 200

The Department of Clinical Research (DKF) offers training grants for members of DKF clinical research groups, as well as for PhD students of the following disciplines: Biomedical Engineering, Biomedical Ethics, Clinical Research, Nursing Science, Sport Science, Epidemiology & Public Health, Medicines Development, Insurance Medicine) and for medical students (BSc, MSc and MD human medicine) of the University of Basel. 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. Applications for training grants can be submitted when registering for the program.

Medical Faculty of the University of Basel

Course language: 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”. To be valid, participants must have completed a GCP course on investigator or sponsor-investigator level e.g. the GCP-Basiskurs or GCP-Aufbaukurs.

Location

Universitätsspital Basel Hebelstrasse 10, 4031 Basel


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