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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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Addresses safety-triggered reconsent including IB updates and DSMB recommendations, with practical guidance on communicating new risks accurately, managing participant emotions, and documenting the encounter.
The email arrives at 2:17 on a Wednesday afternoon. The sponsor has issued a revised Investigator's Brochure -- Edition 7, superseding Edition 6 from nine months ago. You open the cover letter and scan the summary of changes. Most are routine: updated pharmacokinetic data, revised preclinical findings, minor formatting corrections.
Then your eyes stop on Section 5.3.4: "Cardiac Safety Findings." A new signal. In a parallel Phase II trial of the same compound -- different indication, different patient population -- three participants developed prolonged QTc intervals, and one experienced a cardiac arrhythmia requiring hospitalization. The sponsor has updated the IB to include QTc prolongation as a newly identified risk.
You have 35 participants actively enrolled. They are taking this drug right now. Every one of them sat across from you -- or from the investigator, or from a colleague on the research team -- and heard a description of the risks. That description did not include cardiac arrhythmia. It did not include QTc prolongation. It could not have, because the signal had not yet emerged.
Their consent was valid when they gave it. But it is no longer complete. And the gap between what they were told and what is now known -- that gap is your responsibility to close.
This is safety-driven reconsent. It is not the same as reconsenting for a protocol amendment that adds an MRI scan or extends the visit schedule. Those are logistical changes. This is different. This is telling a human being that the thing you put into their body carries a risk they did not know about when they agreed to take it. The urgency is different. The emotional stakes are different. The documentation requirements are more demanding. And the margin for error -- in your communication, in your timing, in your handling of the participant's response -- is narrower than in any other consent encounter you will face.
What you will learn4 objectives
By the end of this lesson, you will be able to:
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