Data collection, monitoring, and storage of research samples
dengue, febrile, infections
DENGUE, INFECTIONS
All subjects will be a assigned a unique subject identifying code that will link subject name to biological samples. Study personnel involved in laboratory data acquisition, entry, and analysis will not have access to names, thereby protecting the privacy of subjects. Upon enrollment, participants will complete a comprehensive REDCap survey to collect data on time spent in dengue and flavivirus endemic areas, related febrile illnesses, and potential previous DENV infections. These will be reviewed by clinical staff after unblinding. Survey data will be stored in REDCap and clinical data will be stored in the Clinical Research Management Information System (CRIMSON). These secure, web-based applications are designed to support data capture for research studies and are the core data management systems used be NIAID. All data will be checked by study investigators, and external study monitors will verify that the trial is conducted and data are generated in compliance with the protocol, good clinical practice, and applicable regulatory requirements. All data will be archived at the end of the study and retained for the time period consistent with IRB requirements. All biological samples will be received, processed, aliquoted, and stored at NIAID and/or Fredrick National Laboratory. Final, anonymized laboratory data will be uploaded in ImmPort and the database of Genotypes and Phenotypes (dbGaP).