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Module 1: Lesson 1
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.
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 learn
By the end of this lesson, you will be able to:
Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles