Monitoring and Data Safety and Monitoring Activities sections in the Moderna protocol.
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Get it written →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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