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1、Confidentiality/date line: 13pt Arial Regular, whiteMaximum length: 1 lineInformation separated by vertical strokes,with two spaces on either sideDisclaimer information may also be appear in this area. Place flush left, aligned at bottom, 8-10pt Arial Regular, whiteIndications in green = Live conten
2、t Indications in white = Edit in masterIndications in blue = Locked elementsIndications in black = Optional elementsCopyright: 10pt ArialRegular, whiteUser Guide II: Watson LIMS Operation Training Technology Development GroupTechnology Development Group 2007 WuXi PharmaTechAuthor: Yong Jin Date: Jan
3、-2007Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechOutline Projects Studies Master Assays Sample Management Analytical Runs Regression Reassays ReportingTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechProjectsProjects are used to create relationships b
4、etween studies and assays in the Watson system. All studies and master assays within Watson belong to a project. ProjectAssay IStudy AAssay IIStudy BStudy CTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechMain WindowMain WindowGo to Project List FromTechnology Development Group
5、All copyright Reserved 2007 WuXi PharmaTechProject List Project List FormFormGo to Create Project FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Project Create Project FormFormSave the Project InformationTechnology Development GroupAll copyright Reserved 2007 WuXi
6、PharmaTechStudiesAll studies within Watson belong to a Project. Study information usually comes from Study Protocol.Create a Study within a ProjectDesign a StudyStudy DesignSubject DesignTreatment DesignTime point DesignAccept DesignAssign a StudyTechnology Development GroupAll copyright Reserved 20
7、07 WuXi PharmaTechMain WindowMain WindowGo to Study List FromTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStudy List Study List FormFormGo to Create Study FormAssign a study to a user (role)Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Study
8、Create Study FormFormSave the Study Information&Go to Assign Users FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechAssign Users Assign Users FormFormNote: You can assign a user or only a role of a user to a studyTechnology Development GroupAll copyright Reserved 2007 WuXi
9、PharmaTechStudy WindowStudy WindowNote: New menu become available after a study saved and openedTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStudy Actions Study Actions menumenuNote: Functions equivalent to Study List FormTechnology Development GroupAll copyright Reserved 2
10、007 WuXi PharmaTechStudy Design Study Design MenuMenuGo to Study Design FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStudy Study Design Design FormFormNote:Save : save to Local PC & Accept :save to DB ServerNote: It is suggested that save but not accept before confirmin
11、g all design information.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStudy Design Study Design MenuMenuGo to Subject Design FormGo to Treatment Design FormGo to Time Point Design FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechSubject Subject Des
12、ign FormDesign Form-Subjects Tab-Subjects TabEnter Subject InformationNote: Function help for entryNote: Only new subjects (not accepted) can be deleteTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechSubject Subject Design FormDesign Form-Subjects -Subjects Masks TabMasks TabAd
13、d Gender Information to SubjectsNote: All changes only act after ApplyTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechTreatment Treatment Design FormDesign FormEnter Treatment InformationNote: Same function as Subject Design FormTechnology Development GroupAll copyright Reserv
14、ed 2007 WuXi PharmaTechTime Point Time Point Design FormDesign FormDefine non-serial time pointTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStudy Design Study Design MenuMenuNote: After Design Accepted,1. New menu become available;2. Accept Design menu grey out;3. Design Fo
15、rm numbers become bold.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechMaster AssaysMaster assays information usually comes from Method and Validation Plan.Create a Master Assay within a ProjectCreate a Study within a Project Copy Master Assays to a StudyTechnology Development
16、 GroupAll copyright Reserved 2007 WuXi PharmaTechMain WindowMain WindowGo to Master Assay Information FromTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechAssay Assay Information Information FormFormGo to Create Assay FormAssays belongs to the selected ProjectTechnology Develop
17、ment GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Assay Create Assay Form Form -Assay Tab-Assay TabNote: This function only become available when Assay Type is ELIASEnter basic information of this assayDefine a New Analyte or Select a Analyte in DBNote: IS should be selected in Int. Standa
18、rds Tab previously.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Assay Create Assay Form Form -Int. STD Tab-Int. STD TabSelect or define an IS then add it to listTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Assay Create Assay Form Form
19、 -Details Tab-Details TabSelect Assay Instrument and regression typeNote: Import concentration data is unusual. Import Raw Data is suggested.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Assay Create Assay Form Form -Analyte Tab-Analyte TabControl & Transition is opti
20、onal.Estimated parameters number should suitable for regression typeTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Assay Create Assay Form Form -Standards -Standards TabTabNote: Concentration and Flag should be entered, ID& Replicates can be defaultNote: Only be needed
21、 when flags is different between analytesTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Assay Create Assay Form Form - QCs Tab- QCs TabNote: Only be needed when flags is different between analytesNote: Concentration and Flag should be entered, ID& Replicates can be def
22、aultTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCreate Assay Create Assay Form Form - Stability Tab- Stability TabNote: Concentration and Dilution factor should be entered, ID& Replicates can be defaultSave all tabs information then new assay would be createdTechnology Dev
23、elopment GroupAll copyright Reserved 2007 WuXi PharmaTechAssay Assay Information Information FormFormNew assay is created after saveTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechSample ManagementLocation(Address)BoxContainerSamplesLocation(Storage)Storage Box & Shipment BoxT
24、wo types of LocationsSample PathTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechSample Request ProcessCreate a Transfer Request (New or Cancel) Complete the Transfer Request (Open or Complete)DeliveryReturn to StorageSign off the Transfer Request (Sign-off or Problem)AnalystSa
25、mple ManagerAnalystTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechMain Window Main Window -Tracking Menu-Tracking MenuGo to Transfer Request Form (for analyst)Go to Sample Entry Form(for sample manager)Check locations of study samples after Sample Entry (for analyst)Technolog
26、y Development GroupAll copyright Reserved 2007 WuXi PharmaTechTransfer Request FormTransfer Request FormReview RequestsGo to Transfer Request Create FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechTransfer Request Create FormTransfer Request Create FormNote:Delivery or Ret
27、urn to Storage?Go to Choose Location FormNote: Location is necessary just when Request Type is DeliveryGo to Choose Samples FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechChoose Sample FormChoose Sample FormNote: Different methods to choose samplesReturn to Transfer Reque
28、st Create FormStudy samples should be the combination of Subjects & TreatmentsTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechChoose Location FormChoose Location FormReturn to Transfer Request Create FormNote: Location be chosen should be a Location can hold boxes /containersT
29、echnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechTransfer Request FormTransfer Request FormNewly Created Request shown here with status-NewRequest status can be changed by EditTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechAnalytical RunsProjectMaster Ass
30、ayStudy AssayAnalytical RunAnalytical Run AssayStudyCopy by user manuallyDone by LIMS automaticallyTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechMain WindowMain Window-Analytical Menu-Analytical MenuGo toCopy Master Assay FormGo to Plan Analytical Run FormExport Sequence Fil
31、e from worklist & Import Data File for worklistTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechCopy Master Copy Master Assay FormAssay FormOne or More (At Least one)Master Assays belong to This Current ProjectCopy Master Assays to current study as Study AssaysTechnology Develo
32、pment GroupAll copyright Reserved 2007 WuXi PharmaTechPlan Plan Analytical Analytical Run FormRun FormGo to Create New Analytical Run FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechNew New Analytical Analytical Run FormRun Form-Run Info Tab-Run Info TabDefault & unchangea
33、bleRun Type:UNKNOWS/VALIDATION/PSAE/MANDATORY REPEATS/RECOVERYSelect a Study Assay for this Run as Analytical Run AssayNote: PSAE=Pre-Study Assay EvaluationTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechNew New Analytical Analytical Run FormRun Form-Worklist Tab-Worklist TabS
34、elect samples then add them to worklistRearrange the sequence by drag or SortSave to Return to Plan Analytical Run FormExternal Study SampleExternal Reassay SampleTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechPlan Plan Analytical Analytical Run FormRun FormNew Analytical Run
35、 was Created and shownNote: Convenient Function!Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechAnalytical Run Analytical Run Action FormAction FormExport Sequence File Import Data File Note: This Section should Detailed when Operation Demonstration.Technology Development Grou
36、pAll copyright Reserved 2007 WuXi PharmaTechExport Export Sequence FileSequence FileData File Name export from InstrumentFile Prefix of Plan Analytical Run FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechImport Data FileImport Data FileData File comes from Sciex Analyst wi
37、th default formatSelect a runTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechRegressionWorklistRaw DataInstrumentRegressionExportImportRun AssayReassay TagAcceptYesNoTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechMain WindowMain Window-Analytical Menu-A
38、nalytical MenuGo to Standard Regression FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStandard Standard Regression FormRegression FormStep 1. Select a RunAnalyte Status:New/Accept/Unaccept/RejectStep 2. Go to STD Regression of Current RunUse Forbidden!(Bug)Use after regr
39、essionTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechRegressionRegressionChange parameters then re-run regressionFor ELISA StudySTD & QC dataAll Sample dataReturn to STD Regression Form with new statusNote: Double click to Active or Deactive a sampleTechnology Development Gro
40、upAll copyright Reserved 2007 WuXi PharmaTechReassayAnalytical RunResult 1Result 2Sample DatabaseReassayAcceptResult 1 or 2Be reportedReassay SelectionTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechMain WindowMain Window-Analytical Menu-Analytical MenuGo to Reassay Tagging Fo
41、rmReassay Selection Decision&Change the Selection Decision Add Reassay TagTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechAnalytical Run Analytical Run ActionsActionsReassay Tagging for a RunTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechReassay Tagging
42、Reassay TaggingFor selected RunFor selected RunSelect a Comment and Reassay TagPress to apply reassay tag to a sample resultTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechReassay TaggingReassay TaggingFormFormNote: All Sample Results with Reassay Tag with in the study shown i
43、n the grid automatically.Note: You can also add samples and apply reassay tag here.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechPlan Plan Analytical Analytical RunRunPress add to Select Reassay SamplesTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechRe
44、assay Samples Reassay Samples SelectionSelectionSamples with Reassay Tag shown in grid.Select ALQ&BLQ of a RunSelect ALQ&BLQ of combination of Subject and TreatmentTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechNote: After Reassay Run created and Raw Data imported, Reassay Ru
45、n Raw data should be regression and accepted.Reassay RunRegressionRegression Form FormTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechReassay Reassay SelectionSelectionStep 1. Select a sampleStep 2. Select a Result which may be reportedStep 3. Select a reassay reason & reporte
46、d concentration reason.Select a comment for the selected result ( not necessary)Step 4. Store Selection to make decision.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechReview Review Reassay Reassay SelectionSelectionThis form is the same with Reassay Selection Form except win
47、dow header.Note: All reassay samples with decision of reported concentration shown in this grid and can be make a change here.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechReportingDatabaseInformationRaw DataCalculationTableGraphDocumentReportDocument ManagementTechnology De
48、velopment GroupAll copyright Reserved 2007 WuXi PharmaTechCommon Tool Common Tool BarsBarsOutput to Scratch SpreadsheetOutput to Local PC or DatabaseOutput to PrinterTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStudy Actions Study Actions MenuMenuGo to Scratch SpreadsheetTe
49、chnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechScratch Scratch SpreadsheetSpreadsheetNote: Scratch Spreadsheet is temporary memorizer. Data in Scratch Spreadsheet will lose when User Logout.Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechStudy Actions Stu
50、dy Actions MenuMenuGo to Document Management SystemTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechDocument Document Management Management SystemSystemGo to Create Document ( Microsoft Word)Technology Development GroupAll copyright Reserved 2007 WuXi PharmaTechMicrosoft Microsoft WordWordTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechReport Tool BarReport Tool BarTechnology Development GroupAll copyright Reserved 2007 WuXi PharmaTechNext StepNext StepNext StepNext StepUser Guide III: Watson LIMS SOPs
