Ethics in Research (TRREE modules 1, 2 and 3 to be completed)

all year round (online courses)

Modules en ligne via la plateforme TRREE

Course topic: To provide the students with the bases of ethics related to research or clinical trial management. Learned skills and content

Module 1: Introduction to Research Ethics: is an introductory module that presents the basics of research ethics evaluation and the broader context of research ethics. It is designed for anyone intimately or remotely involved with research involving humans. Duration: 2h Objectives: At the end of Module 1 course participants will: • be able to identify values and concepts of ethics relevant to the conduct of research involving humans • be able to identify and consult relevant normative documents • be able to understand the importance of ethical evaluation in the promotion of the highest ethical standards and the protection of humans who participate in research • understand the role and mandate of research ethics committees Overview: Module 1 has 4 parts including 15 questions in all. You must get the correct answer before moving ahead. At the end of this module, a certificate is available for participants who got 70% correct answers on their first try.

Module 2.1: Research Ethics Evaluation: focuses on the training needs of members of Research Ethics Committees (RECs) and any support function. It is also relevant to other stakeholders in the field such as researchers and their teams, or students of faculties who train researchers, who develop research projects and/or who conduct research. Module 2.1 addresses elements that should be considered when assessing if research is ethically acceptable. Duration: 2h Objectives: At the end of Module 2.1 course participants will: • Understand the role of research ethics committees in the promotion of ethical research and the protection of research participants; • Understand the roles and responsibilities of members of research ethics committees; and • Be able to contribute to research ethics evaluation based on the application of principles of ethics and relevant normative documents. Overview: Module 2.1 is divided into 4 parts and has 24 questions in all. You must get the correct answer to each question before moving ahead. At the end of this module, a certificate is available for participants who got 70% correct answers on their first try.

Module 3.1: Informed consent Duration: 2h Objectives: At the end of Module 3.1 all participants will • understand the importance of informed consent for participation in research on humans; • know when the requirement of individual informed consent can be waived At the end of Module 3.1 researchers will • know how to seek informed consent from competent potential research participants • know how to seek informed consent for potential research participants who are unable to give consent; At the end of Module 3.1 research ethics committee members will • be able to evaluate the informed consent provisions in a study protocol; • be able to evaluate a consent form. Overview: Module 3.1 has 5 parts including 12 questions in all. You must get the correct answer before moving ahead. At the end of this module, a certificate is available for participants who got 70% correct answers on their first try.

Module 3.2: Good Clinical Practice (GCP-E6(R2) 2016): This module is a current and comprehensive guide to the elements and principles of Good Clinical Practice (GCP) quality standards for clinical trials. This module is complementary to Modules 1, 2.1 and 3.1 of the TRREE Training program. Those modules need to be completed prior to beginning this one. Duration: 6h Intended audience: The GCP module is relevant to anyone carrying out clinical trials and will be valuable for investigators, nurses, pharmacists, certain members of Ethics Committees, clinical trial monitors, staff working in pharmaceutical companies or in Contract Research Organization. Pre-requisite: Modules 1, 2.1 & 3.1 Overview: Module 3.2 GCP: 37 questions & a Quiz with 25 questions.

The system will automatically save completed material and allow you to continue at a later time.

Fee for the Delivery of the 3.2. Good Clinical Practice (GCP) module TRREE Certificate TRREE's philosophy is based on the right to education and provides free on-line access to e-learning modules. However, the maintenance of the programme and the steady control of its quality, in particular through a regular update of its content, are not without a cost. In order to sustain and bolster the programme, we are therefore introducing a 50 Swiss Francs fee for the delivery of the official Certificate for the 3.2. Good Clinical Practice (GCP) module. This amount will be collected only from participants from high income economies (as identified in the 2016 World Bank's list). We thank you for your understanding and your support that will allow us to continue providing a high quality, accurate and up-to-date training programme in research ethics and regulation worldwide.

Access to the training module itself remains free. Only the delivery of the GCP module

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