Reporting an Amgen Clinical Trial Serious Breach

A Serious Breach is a breach of Good Clinical Practice (GCP), the clinical trial protocol, or an applicable regulation (e.g., European Clinical Trials Regulation) that is likely to impact, to a significant degree, the safety or physical or mental integrity and the rights of the subject or the reliability and robustness of the data and the scientific value of the trial.

If you are working on an Amgen clinical trial at an investigator site and need to report a serious breach, please contact your Amgen point of contact during normal office hours.

If you must report a serious breach outside of normal office hours, please send the completed form to the Amgen Serious Breaches Committee at eu-seriousbreachescommittee@amgen.com  and include "Potentially Reportable Serious Breach" in the subject line. Form template available here.

Additionally, if you prefer to report a serious breach directly to a live call agent outside of normal office hours, refer to the below Clinical Out-of-Hours Support Program.

Clinical Out-of-Hours Support Program

If you are a healthcare professional with an urgent after-hours medical inquiry to treat a patient currently enrolled in an Amgen clinical trial -or- if you are clinical trial staff needing to urgently report a serious breach:

Contact Amgen's Clinical Out-of-Hours Support Program. Dial the toll-free number from the list below that matches your location and a representative will be available to assist. After dialing the toll-free number, you will receive a prompt to enter your return phone number to which an agent will quickly call you back to discuss your inquiry and/or serious breach.

For responses to non-urgent inquiries please contact the clinical trial site Principal Investigator who is best suited to address your question(s). Additionally, refer to Amgen's Product Inquiries site for country-specific Medical Information contact information.