This course is based on the international E6 ICH Good Clinical Practice regulations and is a complete training solution for all individuals that need to acquire GCP knowledge. Our free GCP training can also serve as a refresher course. It is suitable for anyone carrying out, or involved in, clinical research and clinical trials. 

Upon completion of this online course trainees will:

  • be able to understand the basics of Good Clinical Practice and the current legal regulations and guidelines;
  • have the confidence to identify and describe the main responsibilities of the IRB/IEC, the investigator, the sponsor and the monitor;
  • get familiar with the essential documents related to GCP and understand the essence and purpose of important trial related files such as the informed consent forms, the investigator’s brochure and the clinical trial protocol.

Course Content:

  • The definition and main purposes of Good Clinical Practice
  • Historical background of GCP
  • Founder members of ICH (International Conference on Harmonisation)
  • Key facts about the Declaration of Helsinki
  • Importance of GCP and its 13 Core Principles
  • Difference between IRBs and IECs
  • Definition and types
  • Composition, functions and authority
  • Records
  • Definition and responsibilities of the clinical research investigator
  • Definition and structure of the Investigator's Brochure
  • Information about investigational medicinal products
  • Investigation procedures
  • Randomization and unblinding
  • Records and reports
  • The definition of Informed Consent
  • Who should give the information and how
  • Steps in informed consent process
  • What explanations should be given to the trial subject
  • Vulnerable and special populations
  • Things to consider before the trial
  • Definition
  • Trial design and data handling
  • Selection of investigators
  • Compensation to subjects and investigators
  • Financing and regulatory submissions
  • Investigational products - manufacturing, labeling, supplying and handling
  • Reporting of adverse drug reactions (ADRs) and noncompliance
  • Definition
  • Purpose
  • Selection and qualification of monitors
  • Responsibilities
  • Definition
  • Purpose
  • Protocol content
  • Protocol amendment and deviation
  • Source data & source documents
  • What data is documented?
  • Requirements for electronic source records
  • Case report forms - definition & purpose
  • Safety data - AEs, ARs, UARs, SAEs, ADRs
  • How to manage and when to report ADRs?
  • Definition and purpose
  • Clinical trial master file
  • Types of essential documents
  • Essential documents before the clinical phase of the trial commences
  • Essential documents during the clinical conduct of the trial
  • Essential documents after completion or termination of the trial
  • Additional essential documents

This topic is designed to orient students to the Drug Development Process, the clinical research, functions within the corporate and regulatory context from Canadian and international perspectives. Development of drugs is used as a model. 

This topic is designed to provide a framework for understanding the standards and regulations related to the clinical research  functions. The course will start with a historical overview of such documents as the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. Emphasis will be on the International Conference on Harmonization (ICH) guidelines, and GCP. Additionally, safety related topics as the Tri-Council Policy Statement, the Food and Drugs Act, SAP program and privacy legislation will be discussed.

This topic will provide an introduction to clinical research and drug safety data entry, computer systems, ICH guidelines for electronic data management, methods required in the development of clinical research data analysis.

This topic covers the ICHG-E6 regarding the international guidelines for conducting clinical research

This topic is designed to outline the various stages of clinical research including activities as they relate to the monitoring of the clinical trial sites. The course will review the progress of a study from the monitor’s as well as a sponsor’s and investigator’s perspectives and highlight the milestones reached throughout the study. Students will learn the management and organizational aspects of site monitoring combined with the quality control and clinical safety measures that ensure the collection of adequate data in addition to ensuring the safety of trial subjects.