John Costouros - April 6, 2016
Issue Date
Apr 06, 2016
Region
Pacific
Category
Clinical
$117.00
Address 1
450 Broadway St.
Address 2
Pavillion C, Mc: 6342
City
Redwood City
State
CA
Zip/Postal Code
94063
Country
United States
Inspection Range
Mar 25, 2016 - Apr 06, 2016
Pages
4
First Observation
Informed consent was not properly documented in that the written informed consent used in the study was not approved by the IRB, was not signed by the subject or the subject's legally authorized representative at the time of consent, and was not dated by the subject or the subject's legally authorized representative at the time of consent.
Investigator(s): Sandra S. Saniga