Content and Objective of the Course
Clinical trials on humans can only be justified if they are planned, carried out, assessed, and reported scientifically in accordance with ethical standards. In the field of clinical research, national laws, international guidelines, and their implementation have been under continuous development in the past few years. Therefore, it is important that all persons involved in a clinical study comply with these regulations and quality standards. This way, obtaining reliable study results can be assured.
This training offers foundational competencies in the field of European drug and medical device development. Additionally, the training covers the duties of clinical trial investigators. It provides crucial information for productive clinical studies. Please note that this training is compiled within an international context and therefore does not comply with the standards of the German ethics committee intended for certified trainings of the German medical council, such as our GCP-Basic-Training.
The flexibility, adaptability, and accessibility of this online training are its advantages. Users can complete a training program at their own speed and location. Additionally, they have two months to access the training at any time. The online training is always up to date according to new regulations.
Instructions for Participants and General Conditions
The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared with the experience and expertise of the GCP-Service team. The training content serves as a practical guide and clarifies widespread issues and misunderstandings that have come up in the recent past.
The online training consists of four modules, each lasting approximately 60 minutes:
- Introduction: Development of Drugs and Medical Devices
- Investigator Responsibilities Part 1
- Investigator Responsibilities Part 2/Sponsor Responsibilities/Audits
- Inspections and the Reporting of Safety Related Events
The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approximately 45 minutes followed by a multiple-choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approximately 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. After three test runs, the participant must start from the beginning. The individual modules can only be processed in the order of module 1-4. The attendees can download and print the training certificate themselves after finishing all courses and assessments.
All training modules within a training course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.
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