Childhood Adenotonsillectomy Trial

7.4.3 Quality Control of AE Data related to AT

Periodically, results about adverse events will be tabulated. Adverse events that exceed thresholds (identified in Appendix C: Table 1 of the protocol and listed in the Master Manual of Procedures) and any significant deviation(s) from reported national rates will be investigated. If surgical complications are noted that exceed expectation of usual care, or if a site experiences excessive problems (as defined by either the Surgical Quality Control Core (SQCC) or the DSMB), the SQCC Director will initiate an investigation and prepare a report for the DCC, DSMB, Independent Medical Officer and Steering Committee. The Steering Committee (with DSMB approval), may suggest specific actions which may include ongoing monitoring, retraining, excluding the participation of specific surgeons, or excluding specific sites.