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The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?
An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
A protocol amendment is needed to collect additional data from a participant’s medical record. When can the research team begin collecting the additional data?
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?
Which of the following should be considered when implementing a risk-based monitoring plan?
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