Good Clinical Practice (GCP) Refresher Course

Course Content

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 2024, Helsinki) 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).

Learning Contents

Part 1 (Lecture): Basic principles
Types of studies, Legal clinical trial framework in Switzerland, Regulations for clinical research - GCP, Study oversight

Part 2 (Quiz): Applied principles and trial operations

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.

At a Glance

Good Clinical Practice Training for Investigators and Study Teams Medicines Implementation Research at Swiss TPH Clinical Research at Swiss TPH Clinical Operations at Swiss TPH

The course is accredited by Swissethics and listed by TransCelerate. A 'Certificate of Attendance" will be provided if the entire course has been attended and a final test passed.

The goals for participants of this course are:

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

Course fee for external participants: CHF 300

Course fee for employees of the University of Basel / University Hospital Basel: CHF 200

Course fee for Swiss TPH employees: CHF 100

The fee includes training documentation, refreshments.

Cancellation Conditions

The course fee is due on receipt of the invoice. Cancellation is possible up to two weeks prior to the event for a handling fee of CHF 50.00. Cancellations received up to one week prior to the event will be charged 50 % of the attendance fee; cancellations received less than one week prior to the event will be charged the full attendance fee.

Good Clinical Practice (GCP) Refresher Course, 5 December 2024, 13:00 - 16:45 h