This face-to-face compact half-day course on Good Clinical Practice is designed as refresher training covering Good Clinical Practice and regulations in accordance with the requirements of Swissethics. The course summarizes the most important elements of the ICH E6(R3) GCP guideline and will cover selected elements of the conduct of clinical research in the form of a quiz and discussions. It is ideal for all professionals including e.g. Investigators, study coordinators, study nurses, laboratory staff and students involved in clinical research that already obtained basic ICH-GCP knowledge.

The course is accredited by Swissethics (2024).

The participants benefit from the extensive experience of our teachers. Teaching will be very practice-oriented. All teachers can draw on many years of hands-on clinical operations in Switzerland as well as in countries with limited resources.

The course consists of presentations, enriched with practical examples, supplemented with interactive exercises and case studies. Prior to the course, participants will be expected to have read the “Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects” (Version October 2024, Helsinki) and the “ICH Guideline E8(R1) general considerations for clinical studies,” and the “ICH Guideline E6(R3) for Good Clinical Practice” (appr. 3-4 hours).

The course is designed for professionals involved in GCP compliant clinical research who need to be re-certified. Successful completion of basic GCP training in the past is a prerequisite (certificates must be provided upon registration). This course alone does not qualify for initial GCP certification.