Only the initial blood sample for the stratification of patients into their subphenotypes is compulsory. The rest are optional, please see the sampling guide for further information.
Only the initial blood sample for the stratification of patients into their subphenotypes is compulsory. The rest are optional, please see the sampling guide for further information.
No, this will be hospital stock, the costs can be recovered via the excess treatment costs pathway.
10 Days or until ICU discharge.
No, this will be hospital stock
28 Days or until ICU discharge.
The central team will complete all follow up calls. Sites are only required to confirm survival status at these time points.
Yes, they can, but they would need to be listed on the delegation log, as this study is a CTIMP medical oversight is required.
Yes, clinicians confirming eligibility should be listed.
Yes, if a patient lacks capacity the deferred consent model can be applied. Please speak to next of kin first if possible. Always seek retrospective consent once the patient regains capacity.
Yes, if the PI has delegated the responsibility of taking consent to a doctor or nurse either can obtain consent as long as they are appropriately trained.
Only those dealing with the drug supply for the trial, the research pharmacist. Other clinical pharmacists in the hospital or ICU do not.
Any clinician whose role includes prescribing can prescribe drugs for the trial. They do not need to be listed on the delegation log or GCP trained. However, the study pharmacist, who must be GCP trained and listed on the delegation log will oversee the prescribing for the study.
The study (research) pharmacist listed on the delegation log need to be GCP trained. Clinical pharmacists on the wards / ICU do not.
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