How To Run A Brainresearch Biobank

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Lily Merritt
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1 In 7 stappennaareentotale biobank oplossing Erik Steinfelder Labautomation 13 april, Hoevelaken

2 In 7 stappen naar een totale biobank oplossing 1. Defineer het huidige proces 2. Vorm een project team 3. Vastleggen user requirement specification 4. Opstellen van begroting 5. Leverancier selectie 6. Start en voortgang bewaking 7. Project oplevering 2

Vastleggen user requirement specification 4.

3 #1 Defineerhet huidigeproces

Concentrators Freezers Automation Robotics, HCS, 2D Barcodes Preparation Storage Robotics

4 Biobank workflow Prep equipment and consumables Specimen, Biological matrices, splits, derivatives, aliquots, drug compounds, reagents, etc Centrifuges Storage Equipment Concentrators Freezers Automation Robotics, HCS, 2D Barcodes Preparation Storage Robotics Analysis Software Microplate Readers, Mass Spectrometry Services Services Nautilus LIMS Specimen Tracking Software 4

5 Biobank workflow Create Sample Deliver Group or Study or Lots Create Sample Create Aliquot(s) Create Plates Perform Test(s) Report Results Check Results Enter Results 5

6 #2 Vormeenproject team

7 Project team samenstelling Eindgebruiker(s) Detail kennis Betrokkenheid Haalbaarheid Labmanager/Project Manager Totaal overzicht Risico bewaking Resource planning Systeem beheerder Technische input Support & Maintenance.. QA Manager Compliance Kwaliteitswaarborging Finance/ Inkoop Budget Inkoop condities.. 7

Resource planning Systeem beheerder Technische input Support & Maintenance.

8 User #3 Requirement Specification

9 URS example R4 Receive and register samples Requirements to the registration and handling of samples R4.1 Hierarchy of samples It must be possible to setup a hierarchy of samples SB and Cells R4.2 Add new fields Super users must have possibility to add new data fields R4.3 Automatically import of results It must be possible to import results from equipment and other databases R4.4 Flexible data fields It must be possible to have variable fields depending on type of sample (Serum/Cells) R4.5 Sample type and ID It must be possible to register both single samples and collection of samples The system must automatically test for doublets of ID numbers Each sample must have an unique identification R.4.6 Receive and register samples and or data on samples Information on single samples or batches of samples as well as information regarding the donor(s) of the samples is entered into the Biobank LIMS system manually or electronically 9

4 Flexible data fields It must be possible to have variable fields depending on type of sample (Serum/Cells) R4.

10 #4 Opstellen begroting

11 Begroting The UK Biobankis funded by the UK Department of Health, the Medical Research Council, the Scottish Executive, and the WellcomeTrustmedical research charity. The amount needed for the initial participant recruitment and assessment phase is 61 million GBP. Kaiser Permanente "Biobank" Receives $25-Million Grant from National Institutes of Health Million dollar donation for New Zealand s first Biobankfor brainresearch 11

The amount needed for the initial participant recruitment and assessment phase is 61 million GBP.

12 Begroting Request for information Request for proposal Ervaringen van referenties Cost of ownership voorde komendejaren Check of tender nodigis 12

13 #5 Leverancier selectie

14 Leverancierselectie Definieer criteria voor selectie Functionele en technische overeenkomsten met URS Prijs en/of Cost of ownership Standaard vs maatwerk Continuiteit en stabiliteit Locatie Condities. Vergelijk appels met appels Referentiebezoek Demo volgens vooraf gedefinieerd script/workflow 14

vs maatwerk Continuiteit en stabiliteit Locatie Condities.

15 #6 Start en voortgang

16 Start en voortgang Initial Requirements (URS or RFP) Requirements from Workshops Requirements from specification writing Need to track requirements Requirements never just come during pre-sales Workshop sessions Wrap-up sessions Specification writing RTM Requirements repository Signed-off after Workshops RT M Monitor project cost Monetary Timescales 16

just come during pre-sales Workshop sessions Wrap-up sessions Specification writing RTM

17 Start en voortgang Project Initiation Initial Training Workshop sessions Specifications Final Build Deliver 17

18 #7 Project oplevering

19 Oplevering Project Initiation Initial Training Workshop sessions Specifications Final Build Deliver User Acceptance Testing User Training Rollout/Support Handover 19

20 UK Biobank Case Study Effectively Storing and Analyzing Biological Data Major medical research initiative based in Manchester, UK Goal: Build the world s most detailed information resource to support a diverse range of research aimed at improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses and to promote health throughout society. Product: Thermo Scientific Nautilus LIMS was selected to track, store, manage and report on the biological data of 500,000 people as part of one of the largest medical research projects ever conducted. ml 20

life-threatening illnesses and to promote health throughout society.

21 21 Questions?

Biorepository and Biobanking

Biorepository and Biobanking LabWare s solution for biorepositories and biobanks combines powerful specimen tracking and logistics capabilities with specimen processing and workflow management features.