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

0800-345-9411

Australia

1800-957-526

Austria

0800-401-063

Belarus

820-0491-0122

Belgium

0800-77-961

Bosnia and Herzegovina

0800-83-075

Brazil

0800-891-3496

Bulgaria

00800-210-0650

Canada

1-855-481-7501

Chile

0800-914-813

China

400-120-0177

Colombia

01800-518-9130

Croatia

0800-203-321

Cyprus

800-70100

Czech Republic

800-040-470

Denmark

80-40-01-15

Estonia

800-0100-925

Finland

0800-529-305

France

0805-988-145

Germany

0800-181-7587

Greece

00800-848-1558

Hong Kong

800-906-575

Hungary

06-800-88-066

Iceland

800-4499

India

0800-0503390

Ireland

1800-229-911

Israel

01809-349-170

Italy

800-582-792

Japan

0800-080-7878

Latvia

8000-00-69

Lithuania

800-23-440

Malaysia

1-800-81-0017

Mexico

01800-024-0619

Netherlands

0800-022-2186

New Zealand

0800-600-617

Norway

800-62-613

Peru

0800-74567

Poland

800-675-038

Portugal

800-600-854

Romania

0800-630-125

Russia

8-800-301-87-02

Saudi Arabia

0800-880-3039

Serbia

0800-800-840

Slovakia

0800-003-402

Slovenia

080-688980

South Africa

800-233-727

South Korea

00-308-321-0213

Spain

900-973-491

Sweden

0201-20-3034

Switzerland

0800-563-117

Taiwan

800-276-668

Thailand

1-800-018-233

Turkey

0800-621-2528

Ukraine

0800-800-150

United Kingdom

0800-066-8548

USA

1-855-481-7501