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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 · Participant Management: Screening to Retention
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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Manage participant withdrawal requests with respect for autonomy per ICH E6(R3) Section 2.9, navigate data retention discussions, and complete all required documentation.
There is a sentence in ICH E6(R3) that I believe every coordinator should commit to memory — not because it will appear on an exam, but because it represents a foundational ethical commitment that should shape every withdrawal conversation you will ever have. Annex 1, Section 2.8.10(l) states that the participant must be informed that their "participation is voluntary, and the participant may decide to stop taking the investigational product or withdraw from the trial at any time, without penalty or loss of benefits to which the participant is otherwise entitled."
Read it again. "Without penalty or loss of benefits." "At any time." Not "at a convenient time." Not "after completing the current treatment cycle." Not "provided they give a reason." At any time, for any reason, or for no reason at all.
This is not a technicality. It is not fine print. It is the operational expression of the Belmont Report's principle of respect for persons — the recognition that every participant in a clinical trial retains their full moral agency throughout the entire course of their participation. They consented to enter the trial; they do not need permission to leave it.
And yet. I have watched coordinators — good, well-meaning coordinators — respond to withdrawal requests in ways that subtly undermine this right. "Are you sure?" said with a tone of disappointment. "Can we talk about it first?" said in a way that implies the conversation is a gate the participant must pass through before their decision is honored. "The investigator would really like to discuss this with you" said in a way that makes the participant feel they need the investigator's approval. None of this is malicious. But all of it creates friction around a right that should be frictionless.
This lesson teaches you how to handle withdrawal requests in a way that respects the participant's autonomy, fulfills your safety and documentation obligations, and preserves the relationship — because many participants who withdraw from the study intervention remain willing to continue safety follow-up if the withdrawal experience is handled with professionalism and care.
What you will learn5 objectives
By the end of this lesson, you will be able to:
Progress saves itself — finish reading and this lesson completes