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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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Covers storage requirements for signed consent forms, procedures for providing participant copies, managing monitor and auditor access, eConsent storage considerations, and retention requirements.
A monitor arrives for a routine visit and asks a straightforward question: "May I see the signed consent form for Participant 047?" The coordinator walks to the filing cabinet. It is locked -- good. She locates the correct binder, opens it to the consent tab, and produces the signed form within two minutes. The monitor notes the version number, checks the signatures, and then asks a follow-up question: "Can you confirm that the participant received a signed copy?"
The coordinator points to a notation in the consent process documentation: "Copy of signed consent form provided to participant on 14 March 2026." The monitor nods. The review moves on.
This interaction lasted perhaps three minutes, and it went well because three things were true: the consent form was stored securely, it was retrievable quickly, and there was evidence that the participant received a copy. When any of these three elements is missing, the interaction does not go well. I have watched monitors spend 20 minutes waiting for a coordinator to locate a consent form that was misfiled in another participant's binder. I have seen audit findings generated because a site could not demonstrate that participants received copies of their signed forms. And I have observed one genuinely painful inspection in which a regulatory authority asked to see consent forms that had been stored in a basement office -- an office that had flooded six months earlier.
A consent form that cannot be produced is, for all regulatory purposes, a consent form that does not exist. This lesson addresses everything between the moment the form is signed and the moment -- years later -- when it may finally be destroyed: where to store it, how to secure it, who may access it, what the participant receives, and how long it must be retained. These are not glamorous topics. But they are the topics that separate sites that can demonstrate compliance from sites that merely assert it.
What you will learn4 objectives
By the end of this lesson, you will be able to:
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