Mia Johnson, Principal CRA
Monitoring medical device studies is not simply restricted to comparing the accuracy of data entered into the electronic Case Report Form against source documentation. Implementing centralized monitoring, which includes reviewing data for unique trends and outliers across subjects and sites, along with source data verification facilitates in ensuring patient safety and data integrity.
Monitoring for accuracy and completeness of informed consent forms for all subjects and the presence of clear informed consent process documentation is another method to ensure patient safety. Furthermore, direct access to medical records or obtaining access to records that are certified as being a complete and accurate representation of the original record assists in the prevention of adverse event under reporting and also provides assurance of the legitimacy of the source data.
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