b. Biannual study audit: An Independent Study Monitor will be assigned by the Research Trials Office of the FHCRC/University of Washington’s Division of Oncology and an independent s tudy audit will be performed two times a year (approximately every 6 months). This audit will be conducted on all patients who have been enrolled on study at the time of the audit. Charts will be formally audited for completeness, accuracy and compliance to protocol. 10% of all computer data entry will also be reviewed. 2. Data validity/integrity Systems to insure data integrity have been put into place to provide multiple checks to data entry. Subject eligibility is reviewed by the Research Nurse at screening, by the Research M.D. at enrollment, by the P.I. at a weekly meeting, quarterly by the Research Nurse chart audit, and biannually by the Independent Study Monitor. Source documents are initially reviewed by the Research Nurse monthly and quarter ly for completeness and reviewed by the Independent Study Monitor biannually. All clinical laboratory monitoring data is reviewed in real time by the Research M.D. and any abnormalities are assessed. Any abnormalities are reported to the P.I. at weekly m eetings. All subject’s records are kept in the research file and reviewed at quarterly and biannual 6304p Protocol 118 04/06/2016 4 audits. All toxicity scoring is reviewed with P.I. at weekly meetings and end of study toxicity scoring is done by the research nurse, reviewed by the P.I . and audited by the Independent Study Monitor and at biannual meetings as described above. All research data is checked by the P.I. and reviewed with the technologist or staff scientist who generated the data. Data is taken from the subject’s source doc uments and entered into a data base which links data to subject by a Unique Patient Identifier and is accessible by password code only. Data entry is made by the Study Coordinator and is verified at end of study by the Research Nurse and the P.I. by revie wing all source documents and reconciling them to the study database. 10% of all data entry is reviewed by the Independent Study Monitor. At the time of study reports or publications print outs of all data from the data base are reviewed by the P.I. Table 1 . Protocol 118 Clinical Trials Personnel Name Role Mary L. (Nora) Disis, M.D. Principal Investigator Lupe Salazar, M.D. Research M.D. Devon Webster, MD Senior Fellow Doreen Higgins, BSN Research Nurse Katherine Guthrie, Ph.D . Statistician Cora zon de la Rosa, BSMT Research Lab Manager Independent Study Monitor for Bi -annual Audits Assigned by Research Trials Office FHCRC/University of Washington/ Division of Oncology Jennifer S.