Section 4 of ICH E6(R3) responds to this reality. It establishes requirements that span the entire data lifecycle—from initial capture through correction, transfer, and eventual destruction. Unlike Section 2.12, which focused on record-keeping at the investigator site, Section 4 addresses data governance as a shared responsibility between sponsors and investigators. While Section 4.3 addresses computerized systems specifically, the broader Section 4 framework focuses on the data themselves rather than the systems that process them.

In my experience teaching GCP over three decades, I have observed that data problems rarely stem from a single point of failure. They emerge from gaps between responsibilities—where the sponsor assumes the site is managing something, and the site assumes the sponsor is handling it. Section 4 closes those gaps by making obligations explicit for both parties.

This lesson examines Section 4 in depth, focusing on how its requirements translate into daily practice for clinical research professionals.

Section 4 of ICH E6(R3) responds to this reality. It establishes requirements that span the entire data lifecycle—from initial capture through correction, transfer, and eventual destruction. Unlike Section 2.12, which focused on record-keeping at the investigator site, Section 4 addresses data governance as a shared responsibility between sponsors and investigators. While Section 4.3 addresses computerized systems specifically, the broader Section 4 framework focuses on the data themselves rather than the systems that process them.

In my experience teaching GCP over three decades, I have observed that data problems rarely stem from a single point of failure. They emerge from gaps between responsibilities—where the sponsor assumes the site is managing something, and the site assumes the sponsor is handling it. Section 4 closes those gaps by making obligations explicit for both parties.

This lesson examines Section 4 in depth, focusing on how its requirements translate into daily practice for clinical research professionals.