It can be accessed from any web browser. User name and password will be generated by the Data Manager of Cancer Insight and sent via email to appropriate site personnel prior to enrolling the first patient. Clinical nurses at the site will be provided with Source Document Flow Sheets to capture data at enrollment and for each study 33 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 visit. Although some data fields on the Flow Sheets will not be entered into EDC, they must be captured on the Flow Sheets for monitoring purposes. All data .must be submitted within 72 hours of the data collection visit. Data entry will begin with the patient’s randomization with enrollment date to be date of signed informed consent. Edit checks will fire in real time as data is being entered in the EDC system to ensure quality data is provided. In addition to edit checks, queries will be generated as Discrepancy Notes from the Data Manager and Monitors. Sites will have ten business days to update a query. It is the responsibility of the coordinator at each site to ensure that data has been submitted. Cancer Insight quality assurance personnel or the sponsor’s representative will perform an audit of the site-specific Flow Sheets and will match them against source documents to ensure the quality of data coming to the Data Manager in the EDC per the internal monitoring plan. The database, hosted by OpenClinica, resides in a SAS 70 Type II data center and meets ISO 17799 standards for information security. The EDC system is HIPAA and 21 CFR part 11 compliant with robust audit logs, controlled user access and electronic signature/password management. In addition to the site user, the Data Manager, the Monitors, the study PI and Sponsor/Sponsor representative have access to the database.