Good Clinical Practice (GCP)Course 2 of 2

Good Clinical Practice (GCP)

Full course · ICH E6(R3) Principles

Responsibilities and delegation — ICH E6(R3) Principles

Responsibilities and delegation

Learn how investigators can delegate trial activities to qualified staff while retaining responsibility, implementing proportionate oversight, and maintaining documentation that enables monitoring, audit, and inspection.

25 min

Responsibilities and delegation

There is a persistent misconception in clinical research that I encounter with troubling regularity: the belief that delegation means transfer. A coordinator is assigned to obtain informed consent, and the investigator assumes the obligation has been handed off. A nurse is delegated to record adverse events, and the investigator believes that responsibility now rests elsewhere.

This misconception is not merely wrong. It is dangerous.

Delegation does not shift responsibility. It shifts activity. The investigator who delegates consent discussions to a coordinator remains as responsible for those discussions as if conducting them personally. When a regulatory inspector asks why a participant enrolled despite not meeting eligibility criteria, the answer cannot be "the coordinator made that determination." The investigator delegated the activity of screening, not the responsibility for ensuring eligibility was properly assessed.

Section 2.3 of ICH E6(R3) Annex 1 codifies this principle and establishes the framework for effective delegation at investigative sites. It tells us not only that investigators retain responsibility but also how that responsibility must be exercised: through documentation, through ensuring delegate qualifications, through proportionate oversight, through appropriate agreements, and through permitting the verification that sponsors and regulators require.

What you will learn5 objectives

By the end of this lesson, you will be able to:

Apply the principle of delegation with retained responsibility (Section 2.3.1)
Implement proportionate oversight of delegated trial activities
Ensure delegates are appropriately qualified and adequately informed about the protocol, investigational product, and their assigned activities (Section 2.3.2)
Document delegation proportionate to the significance of the activities (Section 2.3.3)
Permit monitoring and auditing by sponsors, inspection by regulatory authorities, and review by IRB/IECs (Section 2.3.5)

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Responsibilities and delegation