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.

Country

Access Number

Argentina

548003459411

Australia

611800957526

Austria

43800401063

Belgium

3280077961

Brazil

558008913496

Bulgaria

3598002100650

Canada

8554817501

Chile

56800914813

Colombia

5718005189130

Croatia

385800790226

Cyprus

35780070100

Czech Republic

420800040470

Denmark

4580400115

Estonia

3728000032140

Finland

358800529305

France

33805988145

Germany

498001817587

Greece

308003252056

Hungary

3680088066

Iceland

3548004499

India

918000503390

Ireland

3531800229911

Israel

9721809349170

Italy

39800582792

Japan

818000807878

Latvia

37180000027

Lithuania

37080023440

Mexico

528000240619

Netherlands

08000222186

Norway

80062613

Peru

5180074567

Poland

48800675038

Portugal

351800600854

Romania

40800630125

Russia

88003018702

Saudi Arabia

9668008803039

Slovakia

421800003402

Slovenia

38680688980

Spain

34900973491

Sweden

46201203034

Switzerland

41800563117

Turkey

8006212528

Ukraine

380800800150

United Kingdom

448000668548

USA

8554817501