Childhood Adenotonsillectomy Trial

4.5 Assay Data Transfer and Alert Notification

Upon receipt at the LBCR, a receipt recording number of samples, volume, and participants data received from will be generated and sent to the Field Center and to the DCC. On a monthly basis, an EXCEL report, containing the following fields will be sent to the DCC for incorporation into the analytical database: pt id, date of draw; date of assay, value, and quality code.

Glucose, insulin, and lipid levels will be batch and processed on a monthly basis. At this time, any level of glucose, total cholesterol or triglyceride exceeding the following thresholds, will be flagged. An email alert will be issued to the respective Clinical Site PI and Study Coordinator, with a copy to the DCC.

4.5.1 Alerts

• Glucose > 125 mg/dl
• Cholesterol > 199 mg/dl
• Triglyceride > 149 mg/dl