This is not a failure of intent. Everyone involved wanted to protect the participant and meet their obligations. It is a failure of clarity. No one had documented precisely who was responsible for what.

Principle 10 of ICH E6(R3) addresses this problem directly. It is one of two principles newly elevated to standalone status in E6(R3), reflecting the recognition that as clinical trials have grown more complex and involve more parties, the question of "who does what" has become both more important and more difficult to answer. Clear, documented roles and responsibilities are not bureaucratic formalities. They are the architecture of accountability.

This is not a failure of intent. Everyone involved wanted to protect the participant and meet their obligations. It is a failure of clarity. No one had documented precisely who was responsible for what.

Principle 10 of ICH E6(R3) addresses this problem directly. It is one of two principles newly elevated to standalone status in E6(R3), reflecting the recognition that as clinical trials have grown more complex and involve more parties, the question of "who does what" has become both more important and more difficult to answer. Clear, documented roles and responsibilities are not bureaucratic formalities. They are the architecture of accountability.