Protection of Human Subjects – Informed Consent and the Patient

Training Course • Siara

About the CPD course

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.

CPD Provider

Siara

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Siara

Siara is a highly specialized and focused organisation offering consultancy, training and development in all aspects of ICH GCP and related guidelines. The strategies and solutions that are offered by Siara are visionary, dynamic, practically focused, and delivered by highly experienced and skilled Siara Consultants. Siara offers a comprehensive portfolio of workshops for building the knowledge and technical expertise that is required of clinical research professionals in order to conduct and deliver on good quality clinical research to internationally accepted ethical standards. Based upon the role an individual plays within clinical research, Siara proposes customized solutions to ensure that the expectations of the roles and responsibilities are fully understood and ultimately implemented in the day-to-day running of a clinical trial. Siara offers solutions at the Sponsor and Investigative Site level.