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December 31, 2022

Monitoring and Data Safety and Monitoring Activities sections in the Moderna protocol.

Review the Site Monitoring and Data Safety and Monitoring Activities sections in the Moderna protocol. These sections are abridged in this document. For this homework, expand the sections. For example, describe how the monitoring plan will:

Ensure the rights and safety of participants

Confirm that the study is conducted in accordance with GCP guidelines

Ensure maintenance of required documents

Verify adherence to the protocol

Monitor the quality of data collected

Ensure accurate reporting and documentation of all AEs and unanticipated problems

You can refer to another document for guidance on the level of detail to be included in a monitoring plan.

https://covid19crc.org/wp-content/uploads/2020/09/mRNA-1273-P301-Protocol-2020.pdf

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