Free GCP Training

Good clinical practice (GCP) is an international quality standard provided by ICH, that helps governments in the development of local regulations for clinical trials involving human subjects.

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Why enroll in this course?

Course Syllabus

  • 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

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