What category is NOT included in the core principles of ICH-GCP?

The core principles of International Council for Harmonisation - Good Clinical Practice (ICH-GCP) encompass several essential aspects that ensure the safety of trial participants and the integrity of data collected. One important aspect is the ethical conduct of clinical trials, covered under principles relating to ethics, informed consent, and the protection of human subjects.

While trial documentation is certainly crucial for maintaining comprehensive records of the clinical trial process, it is not categorized as one of the core principles outlined in ICH-GCP. Instead, the principles focus on broader topics such as ethics, which includes considerations for informed consent, and data quality and integrity, which ensures that the data collected during the trials is reliable and verifiable.

In this context, the principle of trial documentation supports these broader categories rather than standing alone as a core principle.