Good Clinical Practice - ICH Guidelines E6 R2

Annually, millions of clinical researches are conducted globally across various institutions. Among these, many involve humans as test subjects. This matter raises multiple ethical concerns and questions regarding the safety of 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 Harmonization, 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 ICH Guidelines for Good Clinical Practice (GCP). And although they have been present for a long time, clinical researchers often need help interpreting and applying them in their research practices. Seeing this, course developers at Exoexcellence Consultants came forward to design this easy bi-modular course on ICH Guidelines for Good Clinical Practice. The first module introduces enrollees to ICH, its aims, the principles of good clinical practice, and the roles and responsibilities of an Institutional Review Board.

The second module mentions the core requirements of conducting a successful clinical trial. In this regard, they will obtain an explanation of ICH requirements about the roles of trial investigators and sponsors, taking consent from the trial subjects, quality management of the trial and financing, and enacting a flawless trial protocol. Moreover, the last topic of this course mentions all the essential documents needed during different phases of the trial. Enroll in this course today and learn about the ICH requirements to conduct a successful clinical trial.