GCP

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.

FREE Enroll

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

Ready to get started?

FREE Enroll