How-to-Guide: Complete Reference Book on Protocol Deviations Process
Improper Protocol Deviation management is costing the clinical trial industry millions of dollars per year. This represents substantial safety and quality risks that add new additional burdens for clinical teams all over the world. This Handbook (30 pages) explains the overall Protocol Deviations assessment process, lists the involved parties and describes the various methods/ actions provisioned by regulations. We also discuss tools and procedures that may alleviate the burden and improve the outcome of Protocol Deviations management.
Ethical GmbH is an eClinical Company focused on clinical committees and data management. Our approach is based upon our staff’s experience providing platform and service solutions to support some 300 international clinical trials with more than 10,000 investigator sites and hundreds of thousands of patients since 2013. For more information, visit www.protocoldeviation.com.