Everything statisticians ever wanted to know about 50.24 studies but were afraid to ask.”
*Sara Goldkind , CDER FDA Keywords: Ethics Informed Consent After a brief overview of some of the scientific requirements for an ethical study, generally, the presentation will focus more specifically on some of the required conditions necessary for the conduct of clinical investigations with the exception from informed consent for emergency research, under 21 CFR 50.24. Attention will be given to various permissible designs and endpoints for studies conducted under 21 CFR 50.24 as well as the context in which these studies occur. The discussion will also touch upon some of the unique additional protections required by 21 CFR 50.24, such as mandatory establishment of a data monitoring committee, public notification prior to and after completion of the study, and community consultation.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC