Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others: Draft - October 11, 2005
Rockville, MD: Office for Human Research Protections, 2005 October 11: 25 p. [Online]. Accessed: http://www.hhs.gov/ohrp/requests/aerg.pdf [2007 March 10]
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Guidance for Industry: Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events: Draft Guidance Center for Biologics Evaluation and Research [CBER] (United States) (2005-08)