Good Clinical Practice (GCP) Training for Investigators and Study Teams

This compact two-day Good Clinical Practice course is designed in accordance with the requirements of Swissethics and covers the Good Clinical Practice knowledge essential for investigators of clinical trials and their teams. The course consists of a comprehensive overview of ICH-GCP with a focus on the GCP principles, participant protection, informed consent and safety reporting, as well as topics such as study design, data management and submission to ethics committees in Switzerland. The course is ideal for investigators, study personnel and people involved in and/or interested in clinical research. The course is suitable for beginners as well as experienced investigators who need a refresher or need to acquire a certificate.

The course has been accredited by Swissethics since 2016 and listed with TransCelerate since 2017.

Participants benefit from the extensive experience of our teachers. All teachers have many years of hands-on clinical operations, both in Switzerland and in resource-limited countries.

Course Content

The course covers the key principles of the ICH-GCP E6(R2) and ICH-GCP E8(R1) guidelines. The draft version of GCP E6(R3), which is currently in public consultation, will be introduced and considered. We provide a historical overview of the development of international guidelines in clinical research and of the role of ethics committees. The duties of investigators are presented in detail, and those of study sponsors are touched upon. In addition, the phases of drug development, the principles of data management and study documentation of safety reporting and the submission of projects to ethics committees in Switzerland are explained. The importance and organisation of quality management will be demonstrated.

Course Structure

The course consists of presentations, enriched with practical examples, supplemented by interactive exercises and case studies. Prior to the course, participants are expected to have read the 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 to have reviewed the "ICH Guideline E6(R2) for Good Clinical Practice" (approx. 3-4 hours).

At a Glance

Good Clinical Practice (GCP) Refresher Course Medicines Implementation Research at Swiss TPH Clinical Research at Swiss TPH Clinical Operations at Swiss TPH

The course is designed for medical, nursing and scientific staff involved in clinical trials, students as well as individuals who support clinical research activities, such as laboratory personnel, IT and finance professionals.

The course is accredited by Swissethics and listed by TransCelerate. It fulfils the training requirements for investigators, sub-investigators and study team member. At the end of the course, participants must pass an online competency assessment (20 multiple choice questions).

A Certificate of Attendance will be issued if the following conditions are met:

if both full days of the course have been attended
if the online test is passed with at least 70 % correct answers

The objectives for the participants of this course are as follows:

Understand the historical development, 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)
Understand the different phases of drug development
Gain an understanding of the role of ethics committees, in particular their mandate to protect the well-being, integrity and autonomy of patients
Understand the role and responsibilities of the investigator in a clinical study
Understand the submission process to ethics committees and regulatory authorities
Understand 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
Become familiar with the essential study records and to understand the importance of proper document management
Understand the different study designs of clinical trials, the prevention of bias and the basic principles of statistics and protocol optimisation
Adopt good documentation practices
Understand the principles of data capture (e.g. CRF), data quality and data management
Be familiar with the definition and the consequences of research misconduct

Course fee for external participants: CHF 950

Course fee for employees of the University of Basel / University Hospital Basel: CHF 700

Course fee for Swiss TPH employees: CHF 300

The fee includes training documentation, refreshments, coffee breaks, snack/buffet lunch.

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) Training for Investigators and Study Teams, 3 – 4 December 2024