Can Sponsors Answer 6 Questions Regulators Ask During Audits?ByStefan DuerrJuly 1st 2018Switching from paper records to an electronic drug accountability IRT system can benefit sites during FDA trial site audits.
Sponsors—Can You Answer 6 Questions Regulators ask During Audits?ByStefan Dürr,Stefan DuerrJune 1st 2018During an audit, the FDA investigates six areas to determine whether a site is in compliance with federal drug accountability regulations-can sponsors answer them?