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If a patient is discharged from the PICU/CICU, but readmitted to the PICU/CICU after 24 hours and within the 30 day study period. Should we resume collecting the hospital data of the CRF?

April 26, 2017discharged hours patient picu readmitted study

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If a patient is discharged from the PICU/CICU, but readmitted to the PICU/CICU after 24 hours and within the 30 day study period. Should we resume collecting the hospital data of the CRF?

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No, if a patient has been formally discharged from the PICU/CICU, the hospital data of the CRF is permanently discontinued. However continue to collect transfer data up to day 30 and report any SAE’s within the time period specified in the SOP for adverse event reporting.