GCP

GCP Training

Free self-paced online training that explores the Good Clinical Practice (GCP) global quality standard. The eLearning content covers the fundamentals related to the regulations for studies involving human subjects and the mutual acceptance of data.

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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 investigator
  • Definition and structure of the Investigator's Brochure
  • Information about IMPs
  • 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 participants
  • 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
  • Master file
  • Types of essential documents
  • Additional essential documents, training records

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