The database resides on a dedicated program server that is kept in a central, locked computer facility. The facility is supported by two IT specialists who maintain up to date security features including virus and firewall protection. Program access is limited to specified computers as designated by the laboratory director. Each of these computers has a password restricted login screen. The database sample entry program itself is accessed through a password protected entry screen. The database program has different levels of access approval to limit unauthorized changes to specimen records and the program maintains a sample history. Upon specimen receipt each sample is assigned a unique, sequential laboratory accession ID number. All products generated by the laboratory that will be stored either in the laboratory freezers or at a central repository facility are identified by this accession ID. Inventory information will be stored at the vial level and each vial will be labeled with both a sample ID and a vial sequence number. Vial labels do not contain any personal identifier information. Samples are stored inventoried in locked laboratory freezers and are routinely transferred to the NCI-Frederick repository facilities for long term storage. Access to stored clinical samples is restricted. Investigators establish sample collections under “Source Codes” and the investigator responsible for the collections, the protocol Principal Investigator, specifies who has access to the collection. Specific permissions will be required to view, input or withdraw samples from a collection. Sample withdrawal requests submitted to approved laboratory staff by anyone other than the repository source code owner is submitted to the source code owner for approval. The repository facility will also notify the Source Code holder of any submitted requests for sample withdrawal. It is the responsibility of the Source Code holder (the NCI Principal Investigator) to ensure that samples requested and approved for withdrawal are being used in a manner consistent with IRB approval. The Clinical Support Laboratory does perform testing services that may be requested by clinical investigators including, but not limited to, immunophenotyping by flow cytometry and cytokine testing using ELISA or multiplex platforms. When requests are submitted by the NCI investigator for shipment of samples outside of the NIH it is the policy of the laboratory to request documentation that a Material Transfer Agreement is in place that covers the specimen transfer. At a minimum, the lab needs confirmation that one has been executed or an exception was granted from an office authorized to make such exceptions, e.g. NCI Technical Transfer Center. The laboratory does not provide patient identifier information as part of the transfer process but may, at the discretion of the NCI investigator, group samples from individual patients when that is critical to the testing process. 47 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022 The NCI investigator responsible for the sample collection is responsible for ensuring appropriate IRB approvals are in place and that a Material Transfer Agreement has been executed prior to requesting the laboratory to ship samples outside of the NIH. 5.2.2 Translational Tumor Immunology Program Laboratory (TTIPL), NIDCD-Allen Lab All samples are physically stored in Dr. Allen’s laboratory in secure, limited-access facilities with sufficient security, backup, and emergency support capability and monitoring to ensure long-term integrity of the specimens for research. Samples are logged, barcoded and tracked using Freezerworks Summit. This data storage software allows secure tracking of specimens that are completely de-identified, coded linked and tracked with barcodes only. Freezerworks has the capacity to fully audit all individual specimen processes such as location, aliquoting, thawing and shipping. Acquired samples are immediately transported to the NIDCD tissue core where they are processed and barcoded. The patient sticker that was used for transport is immediately destroyed. Unique barcodes generated for each individual sample are linked to patient identification numbers given to laboratory staff by NIDCD research nurses. These unique patient numbers correspond to patient information that is stored in CTDM. Protected patient information in CTDM will be recorded by NIDCD Research Nurses. Aside from the patient label that is immediately destroyed after specimen transport, laboratory staff will not have access to protected patient information. Investigators are granted view, input, and withdrawal authority only for their specimens. They may not view specimen data or access specimens for which they have not been authorized. Access to specimen storage is confined to repository staff. Visitors to the repositories are escorted by repository staff at all times Tissue biopsies will be ordered in CRIS and any linked protected patient data will be stored in the Clinical Trial Data Management (CTDM) system. Should a CRIS screen not be available, the CRIS downtime procedures will be followed. All tissue biopsies collected will be coded and stored in the NIDCD Biospecimen Tissue Bank. Contact information: Biospecimen Tissue Bank Manager: Paul Clavijo, PhD Building 10, Room 7S244 Phone: 301-594-6091 Cell: 240-449-6724 Dr. Clavijo will be notified the week before each sample acquisition at our weekly tissue procurement meeting (Thursdays at 2pm in the NIDCD Conference Room, Building 10, Room 7S233). All pre-treatment biopsies will be performed at the NIH Clinical Center. Post-treatment biopsies will be performed at either the NIH Clinical Center or Johns Hopkins Suburban Hospital. Dr. Friedman will be responsible for obtaining the samples from the OP5 clinic or operating room at the NIH and from Suburban Hospital. 48 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022  Storage, Logging, Access to and Sample Destruction upon Completion Waste tissues will be stored in the NIDCD tissue bank at the NIH Clinical Center. In addition, limited samples may be collected under this protocol as described above.