This analysis was made on June 13, 2018 based on the Internet posted US FDA Data Base of Clinical Investigator Inspections. The results are provided by deficiency codes. The data includes normal “routine” inspections, and not for cause inspections. All sites (US and non-US) inspected between 2014-2017 are included.
The main conclusion is the there are some significant deficiencies discovered despite of that study sites are closely monitored. The monitors or clinical research associates will not be able to detect important deficiencies such as protocol violation (24.5%) and inadequate and inaccurate records (12.1%). Likewise, drug accountability and reporting of adverse events are not always discovered, in 3.4% and 2.1%, respectively of all inspected sites.
The ICH GCP Guideline was introduced 20 years ago: “Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”
Johan Karlberg, MD, PhD
Humanity & Health Research Centre, Hong Kong