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Clinical Research Coordinator
Full course · Informed Consent in Practice
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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Defines which consent tasks may be delegated to CRCs, distinguishes investigator-only responsibilities, and provides a framework for navigating scope boundaries during consent conversations.
The investigator signs the consent form. Everyone knows that. But here is the reality of clinical research as it is practiced in the field: the investigator is frequently not the person who sits with the participant for 30 or 45 minutes, walking through each section of the document, answering questions about visit schedules and blood draw volumes, explaining what "randomization" means in plain language, and gauging whether comprehension is genuine.
The coordinator does that.
And yet, in my experience, remarkably few coordinators have been given a precise answer to a deceptively simple question: What, exactly, am I authorized to do during the consent process -- and where does my authority end?
The answer matters more than most practitioners realize. Not because the boundaries are arbitrary, but because they exist to protect two people simultaneously: the participant, who deserves clinical judgment from someone qualified to provide it, and the coordinator, who deserves clarity about where professional responsibility begins and ends. A coordinator who unknowingly exceeds the scope of delegation is not merely committing a procedural error -- they are assuming liability for decisions they were never qualified or authorized to make.
This lesson draws the map. We will examine what ICH E6(R3) Section 2.8.5 actually authorizes, identify the tasks that may and may not be delegated to coordinators, explore the documentation requirements for consent delegation, and -- perhaps most important -- build a practical framework for navigating the blurry moments that arise in real consent conversations when a participant asks something that sits right on the boundary.
What you will learn4 objectives
By the end of this lesson, you will be able to:
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