Emergency Unblinding

Process Overview

Open Label Trials

24 Hour Emergency Unblinding Call Center

• A 24 hour Call Center (Emergency Unblinding [EUB] Call Center) is being used to provide study
therapy information in emergency situations for blinded and open label trials

− Managed by Parexel; available 24 hours a day / 365 days a year

− Maintains protocols and investigator brochures
− Translators for 170 languages

• In open-label trials, the EUB Call Center is available to

− Investigators - who may need study therapy information to treat the participant in an
emergency situation
− Non-study Health Care Providers (HCPs) – e.g., emergency responders, hospital workers, or other
medical care professionals - who are unable to reach the investigator and may need study therapy
information to treat the participant

• The Call Center is not for the participant or the participant’s family members
24 Hour Emergency Unblinding Call Center Edit slide to either
‘MSD’ or name of CRO
as appropriate

Why is it necessary for open-label trials to use the 24 Hour EUB Emergency Call Center?
• In an emergency situation (e.g., a participant is admitted to the emergency room or is in an
accident), a non-study Health Care Provider (HCP) may need to obtain information about the
study drug in order to provide treatment

• However, the investigator may not always be available

• The Call Center can provide information on the study drug such as mechanism of action, adverse
event profile and drug interactions

• Note: If a non-study HCP contacts the Call Center, the Call Center will contact < MSD or CRO >
who will contact the investigator. The investigator will need to enter AE information, if
applicable, into Inform
Clinical Trial Identification Cards

Clinical Trial Identification Card (protocol refers to ‘Participant Identification Card’)

• Is Required
• Identifies the participant as participating in a clinical trial
• Is provided immediately after the participant signs informed consent
• Is updated at randomization to record allocation number
• Should be carried by the participant while in the study and shown to health care providers if
hospitalized or visiting any medical facility other than the study site
• Needs IRB/ERC approval
Clinical Trial Identification Cards

• The EUB Call Center must have the Product and

Protocol numbers in order to provide accurate
information to the caller

• It is essential that these numbers are properly

completed on the card
Clinical Trial Identification Cards
The Call Center will not ask for the
participant’s name, but it should be
on the card, so in case of an
emergency situation, it can be
confirmed that the card belongs to
the participant

The Product, Protocol, and

Randomization Numbers must
be included on the card

Remember to fill in the

Randomization Number at the
randomization visit

For joint programs, use the MSD

Product and Protocol Numbers
(delete this box if not a joint program)
Clinical Trial Identification Cards

Clinical Trial Identification Card

Please keep this confidential card with you at all
times while you are participating in the study
 
 
In the event of an emergency please contact:
Site/Clinic/Hospital
Study Doctor Name
Business Hours Phone#:
24 Hour Phone #: 24 Hour Site Number
is optional
FOR HEALTH CARE PROVIDERS ONLY (When study doctor not available)
Emergency Phone#: Each country has a local
emergency phone # to be
Back-up Phone#: +441158558558 (UK hosted number) filled in, which takes caller
directly to the EUB Call
Back-up Phone#: +1 978 805 7685 (USA hosted number) Center

Back-up Phone Numbers are provided

Emergency Unblinding Call Center

Additional information regarding the

Emergency Unblinding Call Center
can be found in the
Global Study-Specific Investigator Trial File Binder
Questions?