Help! My Clinical Research Site Is Getting A Sponsor Audit...What Do I Do?

Every site that has gone through a sponsor audits can testify that these audits are very stressful. The best thing to do is to prepare ahead of time by having your QA personnel review the sponsor’s charts and paying attention to important documents such as the ICF. Be aware that even though your site is the one being audited, asking your CRA for assistance is greatly encouraged as their work will also be reviewed.