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Updated in [September 27th, 2023]

What does this course tell?
(Please note that the following overview content is from the original platform)Annually, millions of clinical research studies are conducted globally across various institutions. Among these, many involve humans as test subjects. This raises multiple ethical concerns and questions regarding the safety of human test subjects. In order to resolve these issues, it is necessary to have a complete set of guidelines that can help researchers conduct clinical trials successfully while ensuring safety. Fortunately, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, also known as ICH, has formulated a detailed set of requirements concerning the involvement of human subjects in a clinical trial.
These guidelines are called the ICH Guidelines for Good Clinical Practice (GCP). Although they have been present for a long time, clinical researchers often need help interpreting and applying them to their studies. Recognising this, course developers at Exoexcellence Consultants came forward to design this easy bi-modular course on ICH guidelines for GCP. The first module introduces you to the ICH, its aims, the principles of good clinical practice, and the roles and responsibilities of an institutional review board (IRB).
The second module explains the core requirements of conducting a successful clinical trial. It includes an explanation of ICH requirements about the roles of investigators and sponsors, getting consent from the subjects, quality management of the trial and financing, and enacting a flawless protocol. The last topic details all the essential documents needed during different phases of the trial. Enroll today and learn about the ICH requirements to conduct a successful clinical trial.

We considered the value of this course from many aspects, and finally summarized it for you from two aspects: skills and knowledge, and the people who benefit from it:
(Please note that our content is optimized through artificial intelligence tools and carefully reviewed by our editorial staff.)
What skills and knowledge will you acquire during this course?
During this course on Good Clinical Practice - ICH Guidelines E6 R2, learners will acquire the following skills and knowledge:

1. Understanding of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and its aims.
2. Familiarity with the principles of good clinical practice (GCP) and their application in clinical trials involving human subjects.
3. Knowledge of the roles and responsibilities of an institutional review board (IRB) in ensuring the safety and ethical conduct of clinical trials.
4. Understanding of the core requirements for conducting a successful clinical trial, as outlined by the ICH guidelines.
5. Knowledge of the roles and responsibilities of investigators and sponsors in clinical trials, including obtaining informed consent from subjects.
6. Understanding of the importance of quality management in clinical trials, including monitoring and auditing processes.
7. Knowledge of the financial aspects of clinical trials, including budgeting and financing.
8. Familiarity with the process of developing a flawless protocol for a clinical trial.
9. Understanding of the essential documents required during different phases of a clinical trial, as specified by the ICH guidelines.

By completing this course, learners will be equipped with the necessary skills and knowledge to interpret and apply the ICH guidelines for Good Clinical Practice in their own clinical research studies, ensuring the safety and ethical treatment of human test subjects.
Who will benefit from this course?
This course on Good Clinical Practice - ICH Guidelines E6 R2 will benefit a wide range of individuals and professionals involved in clinical research studies.

1. Clinical Researchers: Clinical researchers who conduct studies involving human test subjects will greatly benefit from this course. It will provide them with a comprehensive understanding of the ICH Guidelines for Good Clinical Practice, helping them interpret and apply these guidelines to their studies. This will ensure that their trials are conducted successfully and in compliance with ethical and safety standards.

2. Institutional Review Board (IRB) Members: The course will also be beneficial for members of IRBs who are responsible for reviewing and approving clinical research studies. It will provide them with a clear understanding of their roles and responsibilities, as well as the principles of good clinical practice. This knowledge will enable them to effectively evaluate the ethical aspects of proposed studies and ensure the safety of human test subjects.

3. Investigators: Investigators involved in clinical trials will find this course valuable as it will outline their roles and responsibilities according to the ICH Guidelines. It will provide them with guidance on obtaining informed consent from subjects, managing the quality of the trial, and enacting a flawless protocol. This knowledge will help investigators conduct their trials in a compliant and ethical manner.

4. Sponsors: Sponsors of clinical trials, such as pharmaceutical companies or research institutions, will benefit from this course as it will explain the ICH requirements regarding their roles and responsibilities. It will provide them with insights on financing the trial, ensuring quality management, and complying with the necessary documentation. This knowledge will help sponsors effectively support and oversee the clinical trial process.

5. Professionals in Regulatory Affairs: Professionals working in regulatory affairs, such as regulatory affairs managers or officers, will find this course useful in understanding the ICH Guidelines for Good Clinical Practice. It will provide them with insights into the requirements and expectations for conducting clinical trials, enabling them to ensure compliance with regulatory standards.

Course Syllabus

An Introduction to ICH and GCP

GCP Essentials for a Clinical Trial

Course assessment