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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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Clinical Research Coordinator
Full course · Informed Consent in Practice
Free Lesson Preview
The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Traces the ethical history of informed consent from the Nuremberg Code through the Belmont Report to ICH E6(R3), establishing the moral foundation for the consent process.
Picture this. A new coordinator arrives at a study site on a Monday morning, ready for a first week in clinical research. The study binder is thick. The training checklist is long. And somewhere near the top of that list sits a task that looks straightforward enough: "Observe informed consent process."
The coordinator watches a senior colleague sit with a prospective participant for nearly 40 minutes. Not reading aloud from the consent form. Not rushing through checkboxes. Sitting. Talking. Listening. Answering questions with a patience that seems, frankly, inefficient.
Afterward, the coordinator asks a reasonable question: "Is all of that really necessary? Could we not just have the participant read and sign?"
The senior colleague pauses. And then says something the coordinator will not forget: "That form you are holding is not paperwork. It is a promise. And the reason it is a promise -- the reason we treat it with this gravity -- is because of what happened when no one asked."
This lesson is about what happened when no one asked.
What you will learn4 objectives
By the end of this lesson, you will be able to:
Progress saves itself — finish reading and this lesson completes