ICH E6 serves as the international standard for which aspect of clinical research?

ICH E6 establishes international guidelines that primarily focus on the design, conduct, monitoring, and reporting of clinical trials. This comprehensive framework is intended to ensure that clinical trials are conducted ethically and scientifically sound, ultimately safeguarding the rights, integrity, and confidentiality of trial participants. By defining best practices, ICH E6 facilitates consistency in clinical research across different regions and countries, enabling the reliable exchange of data and enhancing the quality of trials.

The guidelines encompass various critical aspects, including but not limited to, the responsibilities of investigators and sponsors, the significance of a well-defined protocol, and the necessity of maintaining accurate and timely records. By emphasizing these key components, ICH E6 serves as a foundational document that shapes the standards of clinical research globally.