Composition of the data monitoring committee, its role and reporting structure {21a}
ADVERSE EVENTS, EVENT
As this is a pragmatic study with a retrospective collection of clinical data, the only anticipated risks specific to this study are loss of data confidentiality. The mPATH™ study database is hosted on an encrypted secure server maintained by Wake Forest Information and Analytics Services (IAS). The database is password-protected, and only authorized individuals are granted access. IAS routinely monitors for any security weaknesses or breaches. In the unlikely event of a data breach, IAS will notify the PI who will convene an internal Data and Safety Monitoring committee to review the event and determine the appropriate response. The Data and Safety Monitoring committee will be comprised of the PI, Project Manager, study statistician, and study programmer. Other individuals may be added to the Data and Safety Monitoring committee at the PI’s discretion. In addition, the PI will promptly review any participant or other-reported concerns regarding the study. The PI will report any loss of data confidentiality or other adverse events to the Wake Forest University Health Sciences IRB and the NIH within 2 business days of the discovery of the event.