Confidentiality {27}
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, and the EDC. No information concerning the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. All data entered into the REDCap database will be encrypted and transmitted to the EDC, linked to a unique research identification number, where it will be stored. No identifiable participant information will be transmitted. All biospecimen samples will be linked to research data by a unique research identification number. Personal health information (PHI) will not be shared with any third parties. Research records at local sites will be locked file in a secure room unless being used by research staff, and all computerized information will be maintained on password-protected computers and archived on a secure server. Security measures will be dictated by local regulatory requirements, including but not limited to locked cabinets in locked offices, and 128-bit or greater encryption on secure computers. Only site investigators, research coordinators, and qualified key personnel will have access to these records. Electronic transmission of de-identified records over public networks will be encrypted with virtual point-to-point sessions using SSL or VPN technology. Data will be analyzed and published in aggregated and encrypted form only.