AOPEER Study Management and Good Clinical Practice (GCP)
December 8-9, 2019
The aim of this course is to contribute to the quality of conducting clinical studies at an investigational site by training the investigators about the applicable guidelines and providing practical tips on how to conduct a study including examples and project management tools.
This course is targeted toward certified orthopedic and trauma surgeons, residents, and other medical doctors acting as investigators and/or subinvestigators. This course is also open for study coordinators and any other specialists involved or interested in clinical research.
At the end of this course participants will be able to:
Recognize the importance of conducting research involving human participants.
- Explain the importance of protecting human participants in the design, conduct and follow- up of research projects involving human beings.
- Describe the principles of human research participant protection.
- Identify and describe the basic documents of reference in research ethics
- Explain how conflicts of interest, fraud, and science misconduct can impact design, conduct, and follow up and the measueres to counter them.
- Apply the basic rules of research ethics to assess risks,-
- Obtain informed consent, respecting the participant privacy, obtain ethical clearance
- Obtaining ethical clearance from the competent Research Ethics Committee (REC)
- Describe the responsibilities of investigators in the protection of human participants and how they have the capacity to face them.
- Apply the most relevant project management tools in a clinical study.
This 2-day course is organized in eight modules and includes lectures, interactive workshops as well as panel and group discussions, preceded by online preparation activities.
The course explains the importance of Good Clinical Practice (GCP) guidelines and the ISO 14155 standard for the conduct of clinical studies as well as presenting the basic ethical principles according to the Declaration of Helsinki.
For more information, please visit www.aopeer.org. Access is free for all members of an AO Clinical Division.
Please find a first preliminary course program at the bottom of this page.
Pricing, Payment options and information
20% for AO members, AO Alliance and AO employees
10% for any non-for-profit organization and SwAPP members
Credit card payments are preferred
Cancellation will be charged as follows:
50% until 30 days before the event. No refund thereafter.
Participants should make sure they have cancellation insurance.
If you cannot pay via credit card you can request an invoice. Please note that we will charge you a CHF 30 handling fee in addition to the participant fee. Please therefore contact email@example.com and indicate the official invoice address of the paying person or entity as well as a respective email address the invoice has to be sent to.
Please register here.
- Course material
- Coffee breaks
- Business center at course venue