Submission
2024 Independent Learner: Good Clinical Practice French and English-BASIC (price in effect until March 31 2025) Monday, April 1, 2024 to Monday, March 31, 2025
Details
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 Basic course is composed of 10 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.   

List of Modules for GCP Basic Course
  • International Council for Harminisation (ICH): GCP Requirements
  • Institutional Review Board/Independent Ethics Committee/Research Ethics Board (IRB/IEC/REB)
  • Sponsor Responsibilities and GCP
  • Investigator's Responsibilities and GCP
  • Managing Investigational (Drug) Products According to GCP Requirements 
  • Informed Consent
  • Detection, Evaluation, and Reporting of Adverse, and Serious Adverse Events
  • Administrative Documents
  • Monitoring of Clinical Trials by Sponsors
  • Audits and Inspections in Clinical Trials

This course is available in both French and English.  The translation of the course was accomplished with financial support from Fond de Recherche Sante (FRSQ) and with review support from Consortium de recherche en oncologie clinique du Québec (Q-CROC) . N2 is grateful for their contributions.

WHO SHOULD TAKE THIS COURSE?
These courses are suitable for persons conducting clinical trials of drugs and devices primarily in Canada. Many pharmaceutical companies have accepted CITI courses 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.
Registration
Independent Learner
more info
$298.00

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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