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Customized Laboratory Support Roxann Neumann, RN, BSN, CCRP ACCRU Biospecimen Resource Manager.

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Presentation on theme: "Customized Laboratory Support Roxann Neumann, RN, BSN, CCRP ACCRU Biospecimen Resource Manager."— Presentation transcript:

1 Customized Laboratory Support Roxann Neumann, RN, BSN, CCRP ACCRU Biospecimen Resource Manager

2 Section 14 – Biospecimen Handling Kit information, if applicable Special collection information if applicable (e.g., samples must be collected Monday – Thursday, Friday shipments need special arrangements) Summary table Shipping instructions Research base instructions

3 Section 14.1 Body Fluid Biospecimen Submission Type of biospecimen to submit Mandatory or optional When to submit Reason for submission (background/ methodology section) Where to find specific details for specimen submission Blood/blood products (EDTA whole blood) Mandatory After registration, prior to treatment Genotyping for eligibility (Section 14.41) Section 14.2 Other – UrineMandatory After registration, prior to treatment Defined translational studies (Section 14.42) Section 14.3 Blood/blood products (EDTA whole blood) Optional Multiple draws (see Section for schedule) Defined translational studies (Section 14.43) Section 14.2 Other – Buccal cells Optional Multiple specimens (see Section 1434 for schedule) Banking (Section 14.43)Section 14.3

4 Section 14.2 – Summary Table Indicate if specimen is mandatory or optional Collec-tion tube descrip- tion and/or additive (color of tube top) Volume to collect per tube (number of tubes to be collec-ted) Blood product being processed Before tx, cycle 1, day 1 End of tx Process at site? Storage/ shipping conditions 1 Mandatory None (red) 10 mL (1) SerumXXYes Freeze/ dry ice Mandatory EDTA (purple) 10 mL (3) Whole Blood XNo Refrigerat e/ cold pack (DO NOT FREEZE)

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9 Section 17.1 – Tissue Biospecimen Submission Type of tissue to submit Mandatory or optional When to submit Reason for submission Where to find specific details for submission Diagnostic slidesMandatory As soon as possible after surgery, prior to enrollment Pre-registration requirement, confirmation of diagnosis through central review Section 17.2 Formalin-fixed paraffin-embedded (FFPE) tissue blocks with corresponding H&E (OR unstained slides with corresponding H&E slide) Optional Within ≤30 days following registration Correlative studiesSection 17.3

10 Biospecimen Packaging Pre-packaging (cont’d.) Tissue Forms must be submitted with tissue specimens - Pathology Submission Form (if applicable) - Pathology Reporting Form (if applicable) - Tissue Specimen Submission Form (if applicable) - Surgical Pathology Report - Operative Report (optional, if available) Pathology Submission Form must be entered into the remote data entry system, if available

11 Packaging Glass Slides Use plastic slide mailers when shipping glass slides Recommend taping lid closed as these can open during transit and slides could be damaged. Do not use cardboard/plastic folders. Slides can be crushed.

12 Biospecimen Packaging Pre-packaging Verify ALL information on the biospecimens exactly matches the paperwork being submitted with specimens: - Study ID - Patient registration ID - Patient initials - Accession numbers (tissues) - Date/time of collection (body fluids)

13 Biospecimen Packaging Pre-packaging (cont’d.) Body Fluid Forms Requisition Form (provided with kits or as an Appendix) must be submitted with body fluid specimens: Specimen Submission Forms (Forms packet) must be entered into the remote data entry system or submitted to ACCRU Operations Office if remote data entry is not available

14 BAP Shippers

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16 Biospecimen Packaging Materials must be securely shipped – multi-level packaging recommended: Appropriate storage container (BAP shipping boxes) Ziplock bag for biohazard protection Appropriate specimen transport bag Paper toweling Ship in a Styrofoam container to prevent thermal damage to the specimen

17 Biospecimen Packaging (cont’d.) If applicable, ship specimen with appropriate supplies to maintain proper temperature of specimen - Cold pack for refrigerated specimens - Dry ice for frozen specimens Enclose required biospecimen paperwork with specimen package Verify the mailing address in the protocol and/or kit instructions

18 Biospecimen Packaging (cont’d.) Use courier or overnight (e.g., FedEx, UPS, World Courier), rather than regular postage Body fluids: kits provide shipping label affixed to box Tissues: submitting institution is responsible for shipping cost –cost is already figured in as part of your credit for putting a patient on study

19 Biospecimen Packaging (cont’d.) First point of contact for all of your biospecimen collection, kits or shipment questions should be the Biospecimen Resource Manager. Roxann Neumann, RN,BSN, CCRP

20 Thank you!


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