May 1, 2024
3 minute read
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects. Compliance with GCP ensures that the rights, safety, and well-being of trial subjects are protected, that the data collected is accurate and reliable, and that the results of the trial can be trusted.
Why Learn About Good Clinical Practice?
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Find a path to becoming a Good Clinical Practice. Learn more at:
OpenCourser.com/topic/4sitoe/good
Reading list
We've selected nine books
that we think will supplement your
learning. Use these to
develop background knowledge, enrich your coursework, and gain a
deeper understanding of the topics covered in
Good Clinical Practice.
Is the official guideline for GCP from the ICH, which global organization that sets standards for the development of pharmaceuticals for human use.
Provides a comprehensive overview of the principles of GCP, including the ethical, legal, and regulatory aspects.
Provides a practical guide to the essential principles of GCP, including regulatory requirements, ethical considerations, and data management.
Provides a practical guide to the implementation of GCP in clinical trials, including guidance on study design, data management, and monitoring.
Provides guidance on the ethical and scientific conduct of clinical trials in developing countries, where there are often unique challenges.
Provides a comprehensive overview of the principles of GCP, including the ethical, legal, and regulatory aspects.
Provides guidance on GCP for the pharmaceutical industry, including guidance on study design, data management, and monitoring.
Provides guidance on GCP for regulatory authorities, including guidance on study design, data management, and monitoring.
Provides a concise and practical guide to GCP, including guidance on study design, data management, and monitoring.
For more information about how these books relate to this course, visit:
OpenCourser.com/topic/4sitoe/good