Which section of ICH E6 addresses the responsibilities of the investigator?

Section 4 of ICH E6 outlines the responsibilities of the investigator in clinical trials. This section is crucial as it defines the role of the investigator in ensuring that the study is conducted ethically, in compliance with regulatory requirements, and with the utmost regard for participant safety. It details the investigator's responsibilities related to protecting the rights, safety, and well-being of trial subjects, as well as ensuring the integrity of the data collected.

The responsibilities include adhering to the protocol, obtaining informed consent, maintaining accurate and complete records, and ensuring that all trial staff understand their roles and responsibilities. These guidelines help maintain the quality and credibility of the trial results, which is essential for regulatory submission and public confidence in the research findings.

In contrast, the other sections focus on different aspects of clinical trials, such as quality assurance, compliance with Good Clinical Practice (GCP), and data handling, but do not provide a detailed account of the investigator's specific duties.