Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles
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Learn how ICH E6(R3) requires clear documentation of roles and responsibilities, establishing accountability frameworks that prevent gaps and overlaps while enabling appropriate delegation with maintained oversight.
Consider a scenario that plays out more often than anyone would like to admit: A participant experiences a serious adverse event on a Friday evening. The investigator assumes the sponsor's safety team is handling the regulatory notification. The sponsor assumes the site has already reported to the IRB. The IRB waits for documentation that neither party believes is their responsibility to prepare. Days pass. Deadlines are missed. When regulators eventually inquire, everyone points at everyone else.
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.
What you will learn5 objectives
By the end of this lesson, you will be able to:
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