Content
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials involving human subjects. It provides a framework to ensure that clinical trials are conducted to the highest ethical and scientific standards, and that the rights, safety, and well-being of trial subjects are protected. Compliance with GCP is demanded by Regulation (EU) 536/2014 Clinical Trials Regulation (CTR). National legal supplement to CTR in Germany is the “Arzneimittelgesetz” (AMG).
The training is structured by following the regulations gradually through each section. Knowing the regulations not only from content, but from structure, will raise staffs’ efficiency upon using the regulations in their daily work.
Legal basis is outlined and put in contexts of its historic foundations. Interfaces between GCP, CTR and AMG are ex-plained.
GCP is trained in-depth. The responsibilities of the investigators and sponsor are emphasized. Investigator responsibilities are put in context of common findings on-site. Throughout the GCP training, excursions to prominent historic non-compliances are taken (e.g.Tuskegee study).
Relevant changes from CTR towards its national predecessor regulation, the German “GCP-Verordnung”, are highlighted. Clinical Trial Application System (CTIS) is explained. Application process is wrapped-up.
Focus is put on the AMG sections relevant to a Clinical Trial’s conduct: section 1, 6 and 11. In context of these, an overview about the regulatory authorities in Germany is provided.
Additional content can be prepared according to the needs of the audience. Such can be, but is not limited to: practical workshop elements, basic medical device training (MDR, ISO 14155), computerized systems validation (GAMP 5), expected GCP changes, requirements towards electronic signatures (eIDAS), etc.
Our experience as Sponsor and Full-Service-CRO shows that a yearly GCP refresher training is demanded by German local competent authorities for each staff member participating in a clinical trial. Our training provides you with a comfortable way to fulfill this requirement. It strengthens the knowledge of your staff by providing an external perspective. All this is achieved in the framework of a collegial and professional exchange of experiences.
If you are intrigued to know more about our service, please contact us with your request. We will be glad to develop a custom-offer with you, based on your specific requirements.
Additional GCP offers