Procedure for Emergency Un-blinding
SPLY provides a 24/7 emergency un-blinding support service.
The service is often required for the clinical trials where the emergency un-blinding module in IRT / IWR is unavailable for site staff (e.g. in the event that those users are not able to access the internet for any reason) or in the case of a sponsor / medical monitor approval is required prior to breaking the blind.
All trial specific procedures for emergency un-blinding will be outlined in an approved plan between the client and SPLY.
The SPLY staff are fully trained in each protocol and will have access to the IRT / IWR and subject randomization list if applicable.
The SPLY standard procedure:
1) Global SPLY Helpdesk receives a request for un-blinding by email at emergency@ct-sply.com or a support call on + 45 60 19 84 64
2) Global SPLY Helpdesk will collect callers information (full name, phone number, association with clinical trial, site number and investigators name, subject ID / CRF# , reason for un-blinding and callers email. A ticket with the complete information will be raised to ensure history tracking.
If the request have been received by email; Global SPLY Helpdesk will ensure to add the complete information to the ticket.
Global SPLY Helpdesk will ensure that the requester is on the list of approved emergency un-blinding requester.
3) Global SPLY Helpdesk will un-blind the subject by confirming the treatment group allocation and subject randomisation and screening number, protocol number and site number and investigator name in writing.
Global SPLY Helpdesk will have a custom privileged account to the IRT / IWR system which provides the subject un-blinding function or have the controlled access to the master randomisation list.
4) Global SPLY Helpdesk will forward a BLINDED notification to the trial sponsor / pharmacovigilance department.
We encourage our clients to regularly audit the SPLY procedures to ensure compliance with your company specific requirements and to strengthen the collaboration.