Adverse Events in Clinical Trials: Is a New Approach Needed?
Lancet 2008 August 16-22; 372(9638): 535-536
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Draft Guidance for Industry on Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events; Availability United States. Food and Drug Administration [FDA] (2005-08-23)
Guidance for Industry: Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events: Draft Guidance Center for Biologics Evaluation and Research [CBER] (United States) (2005-08)
A Unified Web-Based Query and Notification System (QNS) for Subject Management, Adverse Events, Regulatory, and IRB Components of Clinical Trials Mitchell, Rick; Shah, Maitri; Ahmad, Sushma; Rogers, Audrey Smith; Ellenberg, Jonas H. (2005)