Eastern time. Each investigator or group of investigators at a CITN member site must obtain IRB approval for this protocol and submit IRB approval and supporting documentation to the CTSU Regulatory Office before they can enrol l patients. CITN member sites can check the status of their registration packets by querying the Regulatory Support System (RSS) site registration status page of the CTSU member web site by entering credentials at https ://www.ctsu.org . Requirements for CITN12 -03 site registration:  CTSU IRB Certification  CTSU IRB/Regulatory Approval Transmittal Sheet  IRB-approved consent form NCI Protocol #: CITN12 -03 Version Date: July 26, 2017 20 4.2 Registration Process Patient registration can occur only after pre -treatment evaluation is comp lete, eligibility criteria have been met, and the study site is listed as ‘approved’ in the CTSU RSS (Regulatory Support System). Patients must have signed and dated all applicable consents and authorization forms. Patient enrollment will be facilitated using the Oncology Patient Enrollment Network (OPEN). OPEN is a web -based registration system available on a 24/7 basis. All CITN member site staff will use OPEN to enroll patients to this study. OPEN is integrated with the CTSU Enterprise System for reg ulatory and roster data and, upon enrollment, initializes the patient position in the RAVE database. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members’ side of the websi te at https://www.ctsu.org . Prior to accessing OPEN CITN member site staff should verify the following:  All eligibility criteria have been met within the protocol stated timeframes. Site staff should use the registration forms provided on the group or CTSU web site as a tool to verify eligibility.  All patients have signed an appropriate consent form and HIPAA authorization form (if applicable). Access requirements for OPEN:  CITN member site staff will need to be registered with CTEP and have a valid and active CTEP -IAM account. This is the same account (user id and password) used for the CTSU members' web site.  To perform registrations, the site user must have been assigned the 'Registrar' role on the CITN roster. Note : The OPEN system will provide the site with a printable confirmation of registration information and treatment information. Please print this confirmation for your records. Further instructional information is provided on the OPEN tab of th e CTSU members’ side of the CTSU website at https://www.ctsu.org or at https://open.ctsu.org . For any additional questions contact the CTSU Help Desk at 1 -888-823-5923 o r ctsucontact@westat.com .