{"id":416,"date":"2014-04-22T12:48:45","date_gmt":"2014-04-22T12:48:45","guid":{"rendered":"http:\/\/imperial-blog.dev.thinkfullcircle.com\/?p=416"},"modified":"2022-02-17T19:45:09","modified_gmt":"2022-02-17T19:45:09","slug":"dont-get-audited-tips-for-clinical-sites","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/study-site-management\/dont-get-audited-tips-for-clinical-sites\/","title":{"rendered":"Don\u2019t Get Audited! Tips for Clinical Sites"},"content":{"rendered":"

I once worked with a site that was selected by the Japanese Ministry of Health, Labour and Welfare for a study conducted 15 years earlier.\u00a0 Even though the site was not participating in a trial that was conducted in Japan, the sponsor had submitted a registration and the data package included a compilation of safety and efficacy data from studies conducted almost 20 years in advance.<\/p>\n

As expected, many changes had occurred at the site in 15 years:\u00a0investigators and coordinators had come and gone; records had been sent to an off-site storage facility; and the memory of the study was well-regarded as part of the site\u2019s history.\u00a0 Getting the site prepared for an audit was an epic feat.\u00a0At the time, the site did not have standard operating procedures (SOPs), which made it difficult to follow the thought and activity of the study conduct so many years ago.<\/p>\n

The moral of the story is that sites must ensure that data collection practices are so clear and understandable that someone years later can review the data and understand exactly what was done, and how.\u00a0The way to ensure this is by following global regulations and site SOPs.\u00a0Documentation is the key.<\/p>\n

The mere mention of the word \u201caudit\u201d can strike fear in even the most meticulous among us. Yet audits are a necessary component of the drug development process and assist health authorities in validating data and ensuring that clinical sites are in compliance with the protocol, regulations and Good Clinical Practice (GCP). Consequences of negative audit findings can include, but are not limited to, a written warning for deviations from applicable statutes and regulations, withdrawal of IRB\/EC approval, and even site closure.<\/p>\n

An audit may be conducted by a clinical trial sponsor, institutional review boards or ethics committees, and health authorities such as the Food and Drug Administration. These entities may conduct both announced and unannounced site inspections under any of the following circumstances:<\/p>\n