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[2023] Good Clinical Practice ICH GCP for Clinical Research

[2023] Good Clinical Practice ICH GCP for Clinical Research

Certification on ICH GCP E6 R2 Good Clinical Practice for Clinical Research The Only Complete Course You Can Find Online

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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical research studies involving human subjects. It is designed to protect the rights, safety, and well-being of study subjects and to ensure that the results of the research are reliable and accurately reported.

GCP guidelines were developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), an organization that promotes harmonization of regulatory requirements for drug development. The guidelines are known as the ICH GCP guidelines and are recognized as the global standard for the conduct of clinical research.

The ICH GCP guidelines provide a framework for the design, conduct, and reporting of clinical research studies and outline the responsibilities of sponsors, investigators, and ethics committees. They cover a range of topics, including:

  • Selection and qualification of investigators
  • Informed consent of study subjects
  • Protection of study subjects' rights, safety, and well-being
  • Data management and record-keeping
  • Quality assurance and monitoring of clinical studies
  • Adverse event reporting

GCP guidelines are applicable to all phases of clinical research, including drug development, medical device development, and research involving non-interventional studies. Adherence to GCP guidelines is essential for ensuring the integrity and reliability of clinical research and is a requirement for the approval and marketing of new drugs and medical devices.

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