Childs, MPH Research Coordinator Patricia Fintak, MA Research Coordinator Table 2 . Adverse Event Reporting Regulatory Agency Expected Non-serious (Grade 1 -2) Expected Serious (Grade 3 -5) Unexpected Non-Serious Unexpected Serious/Fatal UW-IRB Annual renewal 24 hours Annual renewal 24 hours FDA Yearly progre ss report 15 days Yearly progress report ASAP within 7 days - Medwatch Form 3500 NCI/CTEP Routine report 24 hours by phone/fax (Grade2) In writing < 10 days 24 hours by phone/fax- ADR Form Study Monitor Routine report 24 hours by Routine report 24 hours by 6304p Protocol 118 04/06/2016 5 phone/fax phone/fax NOTE : The death of any patient on a clinical trial is considered Serious Adverse Event, regardless of attribution and is required to be reported to the IRB, FDA and study sponsor. 6304p Protocol 118 04/06/2016 6 Table 3 . Operational Procedures for Protocol 118 Study Event Specific Action Performed By Screen Telephone screening of interested subjects Study Coordinator/Research Nurse Screening checklist Study Coordinator/Research Nurse Eligibility Initial review w/interested subject Study Coordinator/Research Nu rse Obtain source documents to determine eligibility Study Coordinator/Research Nurse 2º review of eligibility MD/PI Weekly meeting w/PI to report study status/evaluate eligibility Study Coordinator/Research Nurse MD Quarterly evaluation of subjec t eligibility Biannual review PI MD Research Nurse Study Coordinator Independent Study Monitor Consent Obtain Informed Consent MD/PI Monthly Visits Blood draw Research Nurse Physical assessment/toxicity evaluation MD/PI Vaccinate Research Nurse Monitor for immediate reactions Research Nurse Source Document Filled out by Study Coordinator, Research Nurse, MD or P.I. Demographic Data Entry Study Coordinator Monthly review of source documents for completeness Research Nurse Quarterly Chart Review Research Nurse Bi-annual audit for data -safety monitoring Independent study monitor Toxicity Monitoring Monthly monitoring of adverse events with patient at each visit Review of non serious and grade 2 expected adverse events weekly MD P.I. Quarterly review of adverse events Biannual review of documentation of adverse events Research Nurse/PI Independent Study Monitor Report of serious (grade 3, 4 or 5) or unexpected grade 2 adverse event See sections B and C of DSMP, page 1- 4 Research Nurs e and P.I. Immunologic Monitoring - Research data Performed at specific timepoints for each subject Research Lab Manager & Technologist Review of immunologic data PI & MD Computer entry of immunologic data Study Coordinator Study review with P.I. Weekly meeting to report study status/evaluate eligibility, subject recruitment and retention, protocol adherence, and adverse event evaluations (all grade 1 and MD Research Nurse Study Coordinator 6304p Protocol 118 04/06/2016 7 Study Event Specific Action Performed By expected grade 2). Daily on an as needed basis for all unexpected grade 2, or grade 3 -5 adverse events. Twice yearly chart audits Bi-annual evaluation of subject recruitment and retention, protocol adherence, adverse events and participant risk versus benefit. Validation of computer data entry from the so urce document. Independent Study Monitor Assurance of Data Accuracy and Integrity Validation of computer data entry for clinical data Research Nurse Validation of data entry for immunologic monitoring -research data Independent Study Monitor P.I. Annu al reports to: IRB Study Coordinator FDA NCI P.I.