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バイオ研究者・大学院生のための簡単な英語文例集

その13

Length of Reporting Requirements

The proposed changes indicate that reporting is required "until the trial is completed". This term requires further definition. In general, a completed trial is one closed with the institutional IRB. Nevertheless, some investigators have been asked to conduct lifelong monitoring of patients for adverse events. For example, lifelong monitoring for replication competent retrovirus has been required in a number of retroviral gene transfer protocols. Clarification of "completed" is requested.

The Society also asks that OBA work with the FDA to revisit the very onerous task of lifelong monitoring. The Society believes that issues such as the scientific basis for lifelong reporting, patient compliance and inconvenience, and investigator funding and mobility have not been adequately addressed. The Society is willing to bring its expertise and experience to any discussions of this matter.

 


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