NHSBT CTU. Staying true to the protocol Vidheya Venkatesh. The Delegation Log. GCP training CVs Delineation of roles: consenting training. The Screening log. Removal of Patient identifiable data Remember to send monthly. NHSBT Clinical Trials Unit. NHSBT CTU. Pre randomisation.
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Staying true to the protocol
Who is excluded?
Parents will be approached for consideration of immediate study participation.
When platelets <100x109/L
When platelets <50x109/L
Document on PlaNeT-2 log book
When not to give platelets
NHSBT Clinical Trials Unit
Keeping in the right arm
F5 – Bleeding Assessment Tool (BAT)
Major bleed reporting
F14 – Serious Adverse Event
A SAE is an adverse event that results:
Primary outcome: 28 days
28 day scan
End of Study
F11 – Cranial USS at the end of study
PlaNeT-2:Transfer out of recruiting unit