Audits & Inspections
Our site has benefited from the experience we gained through an FDA inspection, three Sponsor initiated audits and an audit conducted at the request of the Principal Investigator.
The P.I. requested an audit in order to gain insight on how we might strengthen our Research Program. The hope was to identify any weaknesses so we could correct them.
The Sponsor initiated audits were conducted as a result of our successes as the Sponsors' highest enrolling site. In one audit it was noted that our training records were not as comprehensive as they could be. We promptly developed a comprehensive manual devoted exclusively to the documentation of training and continuing education for all relevant study team members.
We were audited by the FDA in January 2004; no significant findings were noted and no 483 was issued.