What responsibility does ICH E6 place on the sponsor regarding the research monitoring?

The International Council for Harmonisation (ICH) E6 guidelines outline the responsibilities of various parties involved in clinical trials, with a significant emphasis on the role of the sponsor. According to the guidelines, the sponsor is primarily responsible for ensuring compliance with the study protocol and applicable regulatory requirements while simultaneously safeguarding the rights, safety, and well-being of trial subjects.

This involves implementing appropriate monitoring mechanisms to confirm that the study is conducted in accordance with ethical standards and regulatory demands. The sponsor must proactively manage data integrity, address any deviations from the protocol, and ensure that informed consent procedures are followed correctly. Protecting subjects encompasses not only their rights and well-being but also ensuring that adverse events are reported and managed appropriately.

In contrast, the other options do not encapsulate the core responsibilities laid out for sponsors in ICH E6. Focusing solely on data collection neglects the broader responsibilities around subject safety and overall trial integrity. Managing financial aspects might be part of the sponsor's role but does not directly relate to research monitoring responsibilities. Minimizing the number of trials conducted does not align with the aim of promoting thorough and compliant research practices; rather, each trial should be necessary and justifiable rather than limited for the sake of quantity.