This online training is designed to complement the African Vaccine Regulatory Forum (AVAREF) guideline and checklist for the inspection of clinical trials. It is intended for the professional development of GCP inspectors through self-paced learning. There are a few exercises following the main content, which are designed to present practical examples of considerations for the preparation and conduct of GCP inspections.
Photo credits: WHO / Blink Media – N. K.Acquah
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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles of the Declaration of Helsinki, and that the trial provides the necessary conditions for credible clinical trial data. There are a few exercises following the main content, which are designed to present practical examples of considerations for the preparation and conduct of GCP inspections.
Learning objective: By the end of this course, you should be able to:
Course duration: approximately 3 hours.
Certificates: A Record of Achievement will be available to participants who score at least 80% of the total points available in the final assessment. Participants who receive a Record of Achievement can also download an Open Badge for this course. Click here to learn how.