Independent Learner: Good Clinical Practice 2020 French and English-(price in effect from April 1 2020 to March 31 2021)
In Canada, the International Conference on Harmonisation (ICH) guidance E6 R2: Good Clinical Practice (GCP) has been adopted to aid compliance with regulatory requirements for clinical research. The Full course is composed of 13 modules that present ICH-E6-GCP standards as they relate to clinical trials of drugs, biologics and devices. The content is designed to meet the specific regulatory framework in Canada focusing on the Health Canada Food and Drugs Act, Food and Drug Regulations and the
current version of the Tri-Council Policy Statement (TCPS) - and it also offers information on U.S. Food & Drug Administration (FDA) regulatory requirements. The GCP Refresher course is a summarized version (7 modules) of the Full GCP course, complete with new quiz questions. It is ideal for clinical research investigators who have already taken CITI-Canada GCP training and need to demonstrate that they are up-todate in their knowledge of GCP.  This course is available in both French and English.  
The translation of the course was accomplished with financial support from Fond de Recherche Sante (FRQS) and with review support from Consortium de recherche en oncologie clinique du Québec (Q-CROC) . N2 is grateful for their contributions.

These courses are suitable for persons conducting clinical trials of drugs and devices primarily in Canada. Many pharmaceutical companies have accepted CITI course in lieu of their own in-house training (e.g., Pfizer, Abbott, Novartis, BMS, Astra- Zeneca, Bayer, Lilly, J&J, Roche, Sanofi-Aventis, Pharmanet and Amgen).  The GCP Basic and Refresher courses meet TranCelerate criteria for ICH GCP training for investigator site personnel. This means that completion of the CITI-Canada course eliminates the need for completion of another GCP course often requested by a particular company and thus reduces duplication.
Independent Learner
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Independent Learners purchasing this item are entitled to take this training.  Once payment is processed, the learner will have access to complete the course, for one year after beginning the first module. Anyone who has not completed their course by the one year mark, will have to continue once payment for the following year has been received.

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