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Course Description Clinical research investigators often need to demonstrate that they are up-to-date in GCP training without having to re- take the full GCP course. This GCP Refresher course is a summarized version of the Full GCP course, complete with new quiz questions. It is composed of seven modules that present ICH-E6-GCP standards as they relate to clinical trials of drugs, biologics and devices. TransCelerate BioPharma has recognized that this course meets their criteria for ICH GCP training for investigator site personnel. Course Description Specific training is essential to ensure that all people conducting research with dangerous materials, agents or devices are in compliance with all applicable laws. The course consists of 6 modules: Introduction to TDG, Identification and Classification of Dangerous Goods; Packaging and Containment; Marking and Labelling; Documentation; ERAP and Accidental Release Reporting. Course Description In Canada, the International Conference on Harmonisation (ICH) guidance E6: Good Clinical Practice (GCP) has been adopted to aid compliance with regulatory requirements for clinical research This course is composed of 13 modules that present ICH-E6-GCP standards as they relate to trials of drugs, biologics and devices. This includes regulations in Canada such as Health Canada Food and Drug Regulations- Division 5; the Tri- Council Policy Statement, and US Food & Drug Administration (FDA) regulatory requirements. N2 ONLINE TRAINING OPPORTUNITIES N2 has partnered with CITI (Collaborative Institutional Training Initiative) to provide a source of high quality, web-based, Canadian instruction on a variety of research topics. These courses encourage research with human participants to be conducted in a manner that is appropriate, safe, responsible, ethical and meets the guidelines, regulations and legislation in this country. The courses in the CITI-Canada curriculum are composed of modules and quizzes; completion certificates are generated for successful learners. N2 provides FREE access to the CITI-Canada program for N2 member organizations. If you are a member of N2 simply go to the CITI-Canada log-in page: https://www.citiprogram.org/, where you may access the program. For non-member individuals, N2 can provide limited access for a nominal fee. Please contact us for more information: http://n2canada.ca/contact-us/. www.n2canada.ca Good Clinical Practice The course is suitable for persons conducting clinical trials of drugs and devices primarily in Canada. Several pharmaceutical companies have accepted CITI-Canada’s GCP course in lieu of their own in-house training including; Pfizer, Abbott, Novartis, BMS, Astra-Zeneca, Bayer, Lilly, J&J, Roche, Sanofi-Aventis, Pharmanet and Amgen. WHO SHOULD TAKE THIS COURSE? Good Clinical Practice Refresher Course TDG/IATA (Transportation of Dangerous Goods/International Air Transport Association) The course is suitable for persons conducting clinical trials of drugs and devices primarily in Canada who have already taken GCP training such as the CITI-Canada Full GCP course. Many pharmaceutical companies have accepted CITI-Canada’s GCP course in lieu of their own in-house training . The course is suitable for a broad range of audiences ranging from researchers working in labs that handle dangerous goods to clinical research staff or anyone involved in the packaging, transportation and/or receiving of dangerous goods.(ie lab samples , bodily fluids). WHO SHOULD TAKE THIS COURSE? WHO SHOULD TAKE THIS COURSE? Course Description How should you conduct your research? What practices should you follow? Researchers are expected by the public and by their colleagues to follow many rules and commonly accepted practices. The three Responsible Conduct of Research (RCR) courses provides the learner with a solid foundation of knowledge relating to the norms, principles, and rules governing responsible research practice in Canada. The course modules are written at a general level and there are case studies within each course that are specific to their respective discipline. Course Description Part C, Division 5 of the Food and Drug Regulations addresses drugs for clinical trials involving human subjects. According to Health Canada the Qualified Investigator must ensure compliance with the Regulations from every person conducting clinical trials on their site. The successful completion of this course can be used as evidence of training in Division 5 Regulations. This course covers all research subject to Division 5 Regulations and provides practical solutions and methods for complying with the Regulations Course Description This course provides information about the ethical conduct of social and behavioural research with human participants. It covers the current version of the Tri-Council Policy Statement (TCPS) in even greater detail that the tutorial offered by the Panel on Research Ethics, with more information that is specifically aimed at a social and behavioural research audience. Modules include: History and Ethical Principles, Assessing Risk in Social and Behavioural Sciences; Informed Consent; Privacy and Confidentiality; Research with Children; Research in Vulnerable Circumstances; Internet Research and Conflicts of Interest. Social & Behavioural Research Ethics The course is suitable for all persons who conduct or review or who have responsibilities for setting policies and procedures with respect to social and behavioural research. WHO SHOULD TAKE THIS COURSE? RCR: Life Sciences, Physical Sciences, Social Sciences & Hummanities Division Five Drugs for Clinical Trials Involving Human Subjects These courses are suitable for researchers, students and other personnel from a variety of disciplines and fields. This course is suitable for any persons conducting clinical trials of drugs in Canada WHO SHOULD TAKE THIS COURSE? WHO SHOULD TAKE THIS COURSE? www.n2canada.ca NETWORK OF NETWORKS RÉSEAU DES RÉSEAUX N2 Course Description This course is an introduction to a variety of ethics issues that are important to consider when conducting biomedical research with human participants. It will assist in the understanding and appplication of principles of ethics, ethics guidelines, regulations and legislation when conducting biomedical research. The course covers the current version of the Tri-Council Policy Statement (TCPS) in even greater detail than the tutorial offered by the Panel on Research Ethics with more information aimed at a biomedical research audience. Biomedical Research Ethics This course is suitable for all persons involved in biomedical research with human participants, such as healthcare providers, academics, researchers, research personnel, REB members, administrators and research coordinators. WHO SHOULD TAKE THIS COURSE? START YOUR TRAINING NOW If you are a member of N2 simply go to the CITI-Canada log-in page: https://www.citiprogram.org/, where you may access the courses that have been selected by your institution. If you are not a member of N2 or would like more information please contact us; http://n2canada.ca/contact-us/ May 2015 ONLINE EDUCATION L’ÉDUCATION EN LIGNE N2
