appendix 3 qol questionnaires
blood collection

Blood collection will adhere to the protocol for all patients accrued from the participating site.  
Samples (6 ml of blood/tube) will be obtained at each visit as noted in the protocol by VHS research personel. The exception to this will be if the intital blood sample is obtained immediately prior to surgery, which will be occurring at Mount Sinai Hospital and Mount Sinai West. All other blood samples will be stored in the VHS. Viable lymphocytes will be processed from green top tubes using standard ficoll-hypaque density gradient separation. Buffy coat layers will be stored as viable cells in DMSO-containing media at -80C to -170C. Blood for serum will be spun within 5 hours of collection. Blood tubes will be spun at 3000 x g for 10' at 4C and the serum removed by pipetting. Serum will be stored in 1ml aliquots. All samples will be stored at -80C. White blood cell fraction will be stored in a single tube at local institutional temperature guidelines and kept locally. Blood samples will then be batched shipped to the Mount Sinai Health System Immune Core (as outlined above) at frequencies appropriate for the number of samples.
appendix 3 qol questionnaires
specimen banking

As no surgical intervention/transoral robotic surgery will be performed at the VHS Participating Site, all specimens obtained from subjects accrued at VHS will be managed per the protocol, as surgical interventions will only occur at Mount Sinai Hospital and Mount Sinai West, and therefore from the standpoint of specimen management, the management is identical and will be handled the same for all SIRS study sujects. Any additional biopsies from the primary tumor or a recurrence obtained at VHS will be processed at the VHS laboratory, reviewed by VHS Department of Pathology, and then shipped to the main biorepository at Mount Sinai for storage for correlative studies.  
Data Management Data Transfers Vulnerable Populations  
  
Multi-Site Human Research (Coordinating Center). Discuss how management and oversight of the project will occur. Describe the process by which the lead PI will collect information from each site and report appropriately to the IRB.  
A. Recruitment materials for each site B. Consent Template with local site PI name and address, for each site C.  
Participating Site Responsibilities: Track Human Subjects Research education/Conflicts of Interest/administrative training Ensure all personnel have completed the education requirements to be allowed to conduct research at their sites through CITIprogram.org Ensure that all financial conflict of interest (FCOI) disclosures have been made through Sinai Central Ensure that any required submission to a grants and/or contracts office to open a new study at a site are made Comply with Mount Sinai Health system research committee review and recommentations: Peer Reviewed Monitoring Committee, Radiation Safety Committee, Storage and Handling of Research Data Transfer of Specimens