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Investigators’ Presentation Sponsor : GSK Protocol: BIODEP Region: EU

Investigators’ Presentation Sponsor : GSK Protocol: BIODEP Region: EU. Presented by: Saba Salman, Global Project Manager. 3077.DOC.PM.G15.2 (09-Apr-2015). Introduction. Introduction. Overview. All clinical laboratory investigations can be divided into 3 phases:

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Investigators’ Presentation Sponsor : GSK Protocol: BIODEP Region: EU

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  1. Investigators’ PresentationSponsor: GSKProtocol: BIODEPRegion: EU Presented by: Saba Salman, Global Project Manager 3077.DOC.PM.G15.2 (09-Apr-2015)

  2. Introduction

  3. Introduction Overview All clinical laboratory investigations can be divided into 3 phases: • Pre-analytical: specimen collection, preparation and transport • Analytical: testing at Quest Diagnostics Clinical Trials • Post- analytical: providing lab reports, interpretation, follow up and retesting

  4. Objectives 1 Review of pre-analytical phase requirements Identify the common pre-analytical errors that can occur during blood specimen collection and transport Look at some proactive steps to reduce potential errors associated with blood collection and transport 2 3

  5. Supplies

  6. The Starter Pack

  7. Reordering Supplies Indicate Quantities 1 Form for Lab Kits, 1 Form for Logistics Supplies Reorder via fax, phone or e-mail Allow 5-7 working days to reorder

  8. Performing a Lab Visit

  9. Investigator Manual • Refer to your Quest Diagnostics study specific investigator laboratory manual for instructions on sample collection and preparation • Reference Ranges for all tests performed by Quest Diagnostics • Lab Certification

  10. Requisition Forms White copy is to be sent with ambient samples Yellow copy is to be retained at site

  11. Requisition Forms Complete the Demographic Section Ensure the Correct Protocol is Indicated Complete the Demographic Section • Incorrect Protocol = results will be • delayed as we transfer results to the • correct study. This also results in a charge • for the sponsor • Incorrect Visit = potential sample being • drawn in error, therefore missing data points

  12. Requisition Forms Ensure you draw and ship only the required tests Ship at the correct temperature Remember: NO OUT OF PROTOCOL TESTING

  13. Requisition Forms Impact of Incorrect Completion Samples drawn in error, missing samples Sponsor is charged for transferring results to the correct protocol Delay of results , NO final report NO protocol specific flagging, No calculated results CRF discrepancies

  14. Specimen Collection and PreparationBIODEP VISIT 1 & VISIT 2 COLLECT: PREPARE: RETURN:

  15. Specimen Collection and PreparationBIODEP VISIT 1 & VISIT 2 COLLECT: PREPARE: RETURN:

  16. Labelling Correct Sample Labelling Handwrite the subject number Wrap vertically around the upper portion of the vial, as close to the top as possible, do not overlap.

  17. Labelling IMPACT Sample being CANCELLED (loss of data for the protocol) due to incorrect labelling or no labelling (“naked samples”) Queries sent to site Delay in final report to site Incorrect Sample Labelling Subject Number Missing Horizontal Placement Crooked Placement Centered Placement

  18. Couriers

  19. Couriers IMPACT : Please note using BACK UP premium couriers for standard shipments is very expensive and will impact the study budget. Sites must use couriers as directed in the Contact and Shipping Appendix The Site Specific Summary provided in your Starter Pack indicates when to use the primary and backup couriers, and provides you with site-specific courier contact telephone numbers Contact your local courier office for package pickup cut-off times and shipment booking Failure to adhere to these times will impact the transit time. Record the booking reference, date/time of the call, and the name of the person contacted

  20. Sample Shipment Preparation Commercial Couriers

  21. Reporting

  22. Reporting Reports sent via fax Review reports thoroughly and sign Clinical Significance Review

  23. Contact Quest

  24. Client Response Center Supplies Reports and Alerts Study Procedures E-MAIL: CRCUS@questdiagnostics.com Toll free numbers can be found in the investigator manual

  25. Summary The Starter Pack and The Reorder Form Contains everything needed for sample collection including the Investigator Laboratory Manual Please re-order at least 5 -7 working days in advance MUST be completed correctly to avoid delay in reporting Please review investigator Laboratory manual for instructions before specimen collection. Please review Shipping Appendix for packing and courier information Sample labelling and Requisition Forms Specimen Collection and Preparation / Logistics

  26. Key Message PLEASE REMEMBER • Site compliance with Quest requirements is essential for the success of the study

  27. Thank You

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