Specimen and data collection
ADVERSE EVENTS, EVENTS
Two biospecimens will be collected: oral (swab and fluid), and blood via venipuncture. The research coordinators will be trained in phlebotomy by the ICTR and follow Good Clinical Practice (GCP). In addition, trained phlebotomists will be available for venipuncture for participants attending the CRU. Samples will be transported and delivered to JHH laboratories for testing, processing, and storage using standard operating procedures.Survey questionnaires will be conducted using an iPad and answers will be stored in Research Electronic Data Capture (REDCap). The data will be accessed by the research coordinators and team members of the study only using JHU workstations or other computers using the JHU SAFE Desktop feature. The SAFE Desktop is a secure cloud-based platform, which is fully Health Insurance Portability and Accountability Act (HIPAA) compliant and managed by JHU. Examination of participant medical charts will be conducted using JHU workstations or using the SAFE Desktop feature. A group of designated JHU faculty will have responsibility for monitoring, oversight of adverse events and other protocol events.