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(R2) 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 2013, Fortaleza) and the “ICH Guideline E8(R1) general considerations for clinical studies,” and have browsed the “ICH Guideline E6(R2) for Good Clinical Practice” (appr. 3-4 hours).

• To refresh the knowledge of the principles and content of international guidelines for clinical research (Declaration of Helsinki, ICH-GCP) and their influence on the Swiss legislation (HFG/HRA, VKlin/ClinO, KlinV-Mep/ ClinO-MD, HFV/HRO)
• To focus on the investigator’s role and responsibilities in a clinical study,
• To inform on the submission process to ethics committees and regulatory authorities
• To show the principles of quality assurance and quality control and their implementation in clinical studies, including the importance of Standard Operating Procedures, study monitoring and audits
• To give hints for proper document management
• To understand the different study designs of clinical trials, the prevention of bias and the basic principles of statistics as well as protocol optimization
• How to follow Good Documentation Practices
• To show the principles of data capture (e.g. CRF), data quality and data management