Protection of human rights is one of the fundamental principals of GCP. This 1 Day workshop will discuss the history of informed consent, the development of the informed consent form and the informed consent process.
The key issues in informed consent will be discussed and the roles of the Legally Acceptable Representative and Impartial Witness will be addressed. The dilemmas and issues in consenting vulnerable subjects will be discussed in detail. Current inspection findings will be presented. This is a very practical workshop incorporating role-play, problem scenarios and videos. The documentation expected to demonstrate compliance to the informed consent process will also be described in detail.