Available at: http://www.bt.cdc.gov/agent/smallpox/v accination/mgmt-a dv-reactions.asp ]. 6 DATA COLLECTION AND EVALUATION 6.1 D ATA COLLECTION The PI will be responsible for overseeing entry of data into an in-house password protected electronic system and ensuring data accuracy, consistency and timeliness. The principal investigator, associate investigators/research nurses and/or a contracted data manager will assist with the data management efforts. All data obtained during the conduct of the protocol will be kept in secure network drives or in approved alternative sites that comply with NIH security standards. Primary and final analyzed data will have identifiers so that research data can beattributed to an individua l human subject participant. 6.1.1 Eligible patients must be confirmed and checklist completed. Consent form must be signed prior to registration with Central Registration Information Services. 6.1.2 Data will be secured in NCI C3D database. Da ta will be collected using protocol-specific case report forms, and verified for accuracy an d completeness. Hard c opies of data will be stored in locked secured areas and data will be entered onto a secured electronic data base. The following protocol-specific study forms will be complete and stored: eligibility checklist (developed by Central Registration Office, CRO). A copy of all serious AE forms will be kept in the research record. 6.1.3 Treatment is given according to protocol (dated notes about doses given, complications, and clinical outcomes). 6.1.4 Toxicity is assessed according to protocol (laboratory report slips, etc.) 6.1.5 Response is assessed accordin g to protocol (X-ray, scan, lab reports, and date noted on clinical assessment, as appropriate). 6.1.6 Drug Accountability Records are kept for each patient.6.1.7 We will not report Grade 1 adverse events. All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. Patients will be followed for adverse events for a minimum of 30 days after removal from study treatment or until off-study, whichever comes first. Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 41An abnormal laboratory value will be re corded in the database as an AE only if the laboratory abnormality is characterized by any of the following: xResults in discontinuation from the study xIs associated with clinical signs or symptoms xRequires treatment or any other therapeutic intervention xIs associated with death or another seri ous adverse event, including hospitalization. xIs judged by the Investigator to be of significant clinical impact xIf any abnormal laboratory result is considered clinically significant, the investigator will provide details about the action taken with respect to the test drug and about the patient’s outcome.