Informed Consent Exercise

Description

Review a sample Informed Consent document and determine if it is compliant with the required Elements of Informed Consent outlined in ICH GCP. You will identify any omitted elements and make appropriate corrections to bring the document into compliance.

Review the Sample Informed Consent document and identify (annotate directly on the document) where the required elements are included.

By continuing to annotate the document, identify any missing elements, or elements that are not clearly addressed, and propose language sufficient to address the missing/unclear element(s).

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