AOCID – Good Clinical Practice Course
Why is training in Good Clinical Practice important?
Attendance at a Good Clinical Practice (GCP) course is a legal requirement in many countries for surgeons who wish to conduct clinical research. Every investigator conducting clinical studies is required to follow GCP guidelines. Therefore, GCP training is important for everyone who is involved in clinical research, e.g. investigators, study coordinators, and any additional members of the research team such as study administrators. Furthermore, a GCP course is also very suitable for those who work for a study sponsor, e.g. clinical scientists, clinical research associates, quality assurance managers, safety reporting staff and document control managers.
An AOCID developed course in Good Clinical Practice
Due to wide interest from the scientific community, AO Clinical Investigation and Documentation (AOCID) has developed a GCP course accredited by the Association of Swiss Ethics Committees on research involving humans (swissethics). This course is designed to increase the quality of clinical studies conducted at an investigational site.
Something unique to this GCP course is the clear focus on the principles for the planning, conduct and publication of clinical studies with medical devices in orthopedic and trauma surgery. The course covers the GCP guidelines of the ICH as well as the ISO standard 14155 for GCP in medical device studies. Participants also learn about basic ethical principles according to the Declaration of Helsinki and local regulations that apply in their country. The lectures are augmented by workshops and discussion sessions. The course can be taken over 12 hours (the minimum prescribed length for Principal Investigators), 4 hours (for sub-investigators) or more in-depth over 12 hours.
Feedback is collected from each course attendee. Their inputs are evaluated and, if necessary, feed into a continual revision of the course content.
- Scientific background of clinical studies (study designs, protocol, sample size)
- Regulations and guidelines for studies with medical devices and pharmaceuticals
- Patient information and consent
- Monitoring and data management
- Writing a manuscript
The AOCID Good Clinical Practice course is accredited by swissethics and the Swiss Association of Pharmaceutical Professionals (SwAPP). Previous courses have also successfully received CME accreditation.
Training sessions have been held around the world. Thanks to AOCID's worldwide network, it is possible to run the course in many different countries. We would be happy to discuss the possibility of holding the training in your center. This is a fantastic opportunity for you to offer in-house training of great relevance to your employees and coworkers. If you have only a few candidates for GCP training, it may also be possible for individual participants to join a local course organized at a different clinic/location. Please feel free to contact us to discuss your options.
Quotes from previous GCP course participants
This course covers a good range of important information for the staff and the center intending to do research.
It was more than what I expected, I liked the workshops.
All of the presentations were well presented.
Very friendly and skilled speakers. The workshops were very good.
The course was very good and complete.
The course was very thorough and gives me a feeling of confidence in my work and its quality.