Welcome from Your Project Team!

Transcription

1 Welcome from Your Project Team! Dear Investigator, LabCorp Clinical Trials has been selected by University of California San Francisco to perform the DNA Extraction for Protocol POINT NCT As such, we have the pleasure to provide you and your team with all the necessary information and instructions in order to make our collaboration as successful as possible. Below are the names and toll-free phone numbers of the LabCorp Team Members designated for this study. We encourage you to contact us as frequently as necessary to answer any questions and address any concerns. We are here to provide all needed study assistance and support. Your Site Support Team will be your first avenue of communication on most study-related items. The LabCorp Clinical Trials Department operates between 8H00 and 18H00 (CET), Monday through Friday. Outside office hours and on holidays and weekends, an answering service is connected to the same telephone numbers. Your call will be returned on the next normal working day. All individuals associated with the clinical portion of this study should carefully review all applicable instructions and procedure descriptions prior to submitting or collecting samples. If there are any questions or concerns, please contact any member of the team noted below. We wish you great success with your study and look forward to the receipt of your samples. Sincerely, Tina Cuylen Project Manager Site Support Team Site Support EU Tel. : Fax : MonitoringEurope@labcorp.com Project Manager Tina Cuylen Tel. : cuylent@labcorp.com Associate Project Managers Tel. : /208/212 APMBelgium@labcorp.com Other Numbers LabCorp General Telephone : LabCorp General Fax :

2 CHAPTER 7 Toll-Free Numbers: Australia Austria Belgium Bulgaria Croatia Czech Republic or Denmark Estonia Finland France Germany Greece Hungary Ireland Israel Italy Latvia Lithuania Luxembourg The Netherlands New Zealand Norway Poland Portugal Romania Russia Slovenia Slovakia or South Africa Spain Sweden Switzerland Turkey Ukraine United Kingdom NOTE: In case no toll free number is available for your country, please call LabCorp general telephone or contact the Site Support Team.

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28 APPENDIX 3 Laboratory Accreditation Burlington DNA testing Division Page 1 of 2

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30 APPENDIX 3 LABORATORY ACCREDITATION- Mechelen A valid Laboratory Accreditation is provided with the initial supply. For online accreditation information, access: Page 1 of 3

31 APPENDIX 3 Laboratory Accreditation - Mechelen For more information about the accreditation and a current list of accredited tests please refer to the following website: Page 2 of 3

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33 APPENDIX 3 Laboratory Accreditation RTP 1904 Page 1 of 2

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35 APPENDIX 4 CV Medical Director - Burlington Page 1 of 15

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50 APPENDIX 4 CV Medical Director Page 1 of 3

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53 APPENDIX 4 CV Medical Director RTP Page 1 of 1

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55 SUPPLY REORDER FORM University of California San Francisco Protocol : POINT NCT Site number: by fax: by AdminOps@labcorp.com Investigator: GCP / LSN: Kits QUANTITY KIT TYPE Baseline DNA + Plasma 2. Documents QUANTITY DESCRIPTION CTX MNEMONIC Supply Reorder Form Dry Ice Order Form 3. Additional Material QUANTITY DESCRIPTION CTX MNEMONIC 10 ml EDTA Tube EDT10 2 ml Cryovial CRYO2 10 ml Simport Cryovial 10CRY SECTION TO BE COMPLETED BY THE SITE FOR LABCORP USE ONLY Order placed by: Date received: Order date: Order handled by: Phone number: Date input CTPM/CTX: Date supplies required*: SWO number (CTX only): Expected delivery date: *ALLOW AT LEAST 5 TO 7 WORKING DAYS FOR DELIVERY OF SUPPLIES EU SUPFO DYOF Template CT-GLOB-TEMP-FCD-2 Revision: 6 InfoCard Number: CT-GLOB-PM-FCD-13 Revision: 1 Page 1 of 1