Confidentiality
All data submitted will be coded using numeric identifiers only. Only on-site research staff will have access to records that may identify subjects. Any paper research and clinical records will be stored on-site in a locked cabinet in a secure location. Electronic records will be accessible only by data management staff, clinical monitors, and active site personnel who have furnished the required training and credentials. Subject information will not be released without written permission, except as necessary for monitoring by the FDA.