Childhood Adenotonsillectomy Trial

7.4.1 Serious Adverse Events Related to AT

The clinical site’s unblinded coordinator is responsible for collecting and reviewing the intraoperative data sheet once surgery is completed. In the event of an SAE, the clinical site (PI and/or project coordinator) is responsible for reporting the SAE to the Data Coordinating Center (DCC) within 24 hours of first knowledge of the event via telephone, followed by completion of the corresponding case report form within 48 hours. The guidelines for Reporting of Serious Adverse Events is outlined in Section 12 of the protocol and detailed in the master Manual of Procedures.

The participant and his/her guardian will also be instructed to notify the project coordinator if a serious event occurs. Once DCC is notified, any serious adverse event that might reasonably be due to the study intervention (AT) will be reported to the Surgical Quality Control Core, the Medical Monitor, the DSMB and NHLBI Program Scientist within 24 hours. DCC will also disseminate follow up reports/information. In addition, the site (PI) must promptly report all serious adverse events to their IRB via written, dated notification in accordance with the IRB’s reporting requirements.