Good Clinical Practice - ICH Guidelines E6 R2

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. Enrol today and learn about the ICH requirements to conduct a successful clinical trial.