Basic GCP training: Guidance for investigators, deputies and study team physicians conducting clinical trials in accordance with the Arzneimittelgesetz AMG (German Medicines Act).
Please note that due to the current situation we reserve the right to postpone courses and events at short notice.
This basic GCP training for Investigators is based on the requirements of the German Medical Association(Bundesaerztekammer) and the Working Group of Medical Ethic Committees.
Additionally, the training offered meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
To ensure the safety and well-being of subjects and patients at all times, clinical trials need to be carried out to the highest quality standards and in accordance with national and international guidelines. This seminar equips prospective Clinical Investigators with the necessary skills and knowledge for conducting clinical trials, based on a sound understanding of Good Clinical Practice (GCP), the legal framework, ethical considerations, and the roles and responsibilities of all parties involved in a trial.
Selected topics:
On completion of this seminar, you will have a sound grasp of Good Clinical Practice and a thorough understanding of the regulatory framework governing the conduct of clinical trials today. You will be familiar with the procedures for setting up a trial, the requirements for participation, and know exactly what happens at the regular visits, audits and inspections.
The contents of this seminar comply with Ethic Committees requirements concerning the training of clinical trial investigators. The GCP certificate, which you obtain on successful completion of this course, is recognized by all German Ethic Committees for participation in clinical trials.
The one-day, compact GCP training for Investigators comprises 9 lessons (each lesson lasts 45 minutes) and includes a written assessment. This course is certified by the Medical Association Berlin (“Aerztekammer”), (category A, 9 points).
Basic Methodology
International Ethical Principles and Guidelines
International guidelines and national laws
Preparation of a clinical trial
Conduct of a clinical trial
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