Restrictions on Sample Usage at the Investigative Site Sample Clauses

Restrictions on Sample Usage at the Investigative Site. The Investigator/Sponsor, XBiotech, acknowledges that the conditions for use of this research material are governed by WIRB in accordance with Department of Health and Human Services regulations noted in 45 CFR 46. The Investigator/Sponsor agrees to comply fully with all such conditions and to report promptly to WIRB any proposed changes in the research project and any unanticipated problems involving risks to subjects or others. The Investigator/Sponsor remains subject to applicable State or local laws or regulations and institutional policies that provide additional protections for human subjects. This research material may only be used in accordance with the conditions stipulated by WIRB. Any additional use of this material requires prior review and approval by WIRB. Confidential Property of XBiotech USA Inc. November 11th, 2014 Confidential Property of XBiotech USA Inc. Protocol No. 2010-PT016; VER: 1.9 21 February 2012 1 STUDY TITLE: Analysis of Whole Blood from Healthy Individuals to Discover Various Antibodies PROTOCOL NUMBER: 2010-PT016 PROTOCOL VERSION / DATE: VER 1.9/ 21 February 2012 SPONSOR/INVESTIGATOR: XBiotech USA, Inc. 0000 X Xxxxxxxxx Xxxxx Xxxxxxxx 0, Xxxxx 000 Xxxxxx, Xxxxx 00000 U.S.A. Phone: 000-000-0000 Xxxxxxx Xxxxxxx, M.D. XBiotech USA, Inc. 0000 X Xxxxxxxxx Xxxxx Xxxxxxxx 0, Xxxxx 000 Xxxxxx, Xxxxx 00000 U.S.A. Phone: 000-000-0000 Xxxxxx Xxxxxxxxxx Ph.D. XBiotech USA, Inc. 0000 X Xxxxxxxxx Xxxxx Xxxxxxxx 0, Xxxxx 000 Xxxxxx, Xxxxx 00000 U.S.A. Phone: 000-000-0000 Xxxxx X Xxxxx, Ph.D. XBiotech USA, Inc. 0000 X Xxxxxxxxx Xxxxx Xxxxxxxx 0, Xxxxx 000 Xxxxxx, Xxxxx 78744 U.S.A. Phone: 000-000-0000 STUDY SITE: XBiotech USA, Inc. 0000 X Xxxxxxxxx Xxxxx Xxxxxxxx 0, Xxxxx 000 Xxxxxx, Xxxxx 00000 U.S.A. Phone: 000-000-0000 Confidential Property of XBiotech USA Inc. Protocol No. 2010-PT016; VER: 1.9 21 February 2012 2 TABLE OF CONTENTS PROTOCOL SYNOPSIS 3 1 BACKGROUND 6 2 ELIGIBILITY CRITERIA 6 3 INFORMED CONSENT 6 4 SAMPLE COLLECTION 7 5 SAMPLE PROCESSING AND STORAGE 7 5.1 DURATION OF SAMPLE STORAGE 7 5.2 VIAL LABELING 7 5.3 SAMPLE PREPARATION 7 6 DONOR PRIVACY AND CONFIDENTIALITY 8 6.1 RECORD AND SAMPLE HANDLING 8 6.2 ACCESS TO SAMPLES AND DONOR INFORMATION 9 7 USE OF BLOOD SAMPLES 9 7.1 DATA AVAILABLE WITH SAMPLES 9 7.2 RESTRICTIONS ON SAMPLE USAGE AT THE INVESTIGATIVE SITE 9 Confidential Property of XBiotech USA Inc. Protocol No. 2010-PT016; VER: 1.9 21 February 2012 3 PROTOCOL SYNOPSIS Study Title Analysis of Whole Blood from Healthy Ind...
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Restrictions on Sample Usage at the Investigative Site. The Investigator/Sponsor, XBiotech, acknowledges that the conditions for use of this research material are governed by WIRB in accordance with Department of Health and Human Services regulations noted in 45 CFR 46. The Investigator/Sponsor agrees to comply fully with all such conditions and to report promptly to WIRB any proposed changes in the research project and any unanticipated problems involving risks to subjects or others. The Investigator/Sponsor remains subject to applicable State or local laws or regulations and institutional policies that provide additional protections for human subjects. This research material may only be used in accordance with the conditions stipulated by WIRB. Any additional use of this material requires prior review and approval by WIRB.
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