Record and Sample Handling Sample Clauses

Record and Sample Handling. Blood samples arriving at XBiotech, both screening (Phase I) and units of whole blood (Phase II), will be received and processed only by XBiotech personnel designated by the Principal Investigator. Samples received, stored, and tested by XBiotech employees will only be labeled with a Study Unit Identifier (STU). This number will be generated according to STBTC’s standard operating procedures. XBiotech will maintain a log of receipt and storage of samples, as well as a log of any testing and results. Study participants will be identified in these logs by their STU. The scientists at XBiotech will retain no other donor identifiers. For study participants identified from screening as candidates for donation of a unit of whole blood, XBiotech will request this donation from STBTC using the STU. These participants will be contacted by STBTC. All personal identifying information and demographics linked to a participant’s STU will be maintained and secured by STBTC according to their standard operating procedures. The subject’s original informed consent will be maintained in a secure file at STBTC. This document will only be available to the Principal Investigator, the Clinical Research Manager and any Clinical Research Associates designated to monitor the trial. All records pertaining to the identity of participants in this research study will be maintained as private and confidential. Personal identifying information will only be released with the express written permission of the blood donor or by IRB approval. Blood samples and all records associated with blood samples will be labeled only with a numeric code (STU) that contains no donor personal identifiers. A link does exist between the participant’s name and the numeric code. This link is not available to staff managing samples at XBiotech. Confidential Property of XBiotech USA Inc. Protocol No. 2010-PT016; VER: 1.9 21 February 2012 9