Recipient: Uroplasty Inc.
Product: Investigational devices
Date: 7/19/05
The inspectional report notes that review of subject records across five (5) investigational sites revealed that study procedures were initiated on 30 subjects prior to obtaining the informed consent of these individuals as required by the regulations at 21 CFR Part 50. The inspectional report further notes that the main study monitor, Jeanne Colburn-Sinn, stated during the inspection that the deviation observed is attributable to the fact that monitors only reviewed study records to ensure informed consents were signed prior to the implant procedure, without considering the timing of other study-specific procedures. She further stated that it was not discovered that some study procedures were conducted prior to obtaining informed consent until Clindex software was implemented by Uroplasty in 2004. This software was written to suncover protocol deviations.
In addition to the observations noted on the Form FDA 483, the FDA investigator discussed with Ms. Holman the fact that a number of protocol deviations were not identified until late in the study when it was too late to take actions to prevent their recurrence. The inspection report notes that Ms. Holman replied that the Clindex program, which was not brought on-line until the summer of 2004, did manage to identify a number of deviations not previously noted. The FDA investigator also noted that it is the sponsor’s responsibility to ensure monitoring is adequate to reveal protocol deviations in a timely manner rather than to depend only on software analysis of the data, particularly since this software was not available for most of the study.
Issuer: Center for Devices and Radiological Health (CDRH)
