1/18/2017 SASInterviewQuestionsandAnswers:CDISC,SDTM,ADAMetc|StudySASBlog

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1)WhatdoyouknowaboutCDISCanditsstandards?
CDISCstandsforClinicalDataInterchangeStandardsConsortiumanditisdevelopedkeepinginmindtobringgreat
deal of efficiency in the entire drug development process. CDISC brings efficiency to the entire drug development
process by improving the data quality and speedup the whole drug development process and to do that CDISC
developedaseriesofstandards,whichincludeOperationdataModel(ODM),StudydataTabulationModel(SDTM)
andtheAnalysisDataModelADaM). SelfScore MasterCard
Credit Card for International
2)WhypeoplethesedaysaremoretalkingaboutCDSICandwhatadvantagesitbringstothePharmaceutical Students. Build Credit in the
Industry? US. Apply Today!
A)Generallyspeaking,Onlyabout30%ofprogrammingtimeisusedtogeneratestatisticalresultswithSAS,and
therestofprogrammingtimeisusedtofamiliarizedatastructure,checkdataaccuracy,andtabulate/listrawdataand
statistical results into certain formats. This nonstatistical programming time will be significantly reduced after
implementingtheCDISCstandards. NESUG2011Publication

3) What are the challenges as SAS programmer you think you will face when you first implement CDISC GeneratingtheDefine.XML
standardsinyoucompany?
A) With the new requirements of electronic submission, CRT datasets need to conform to a set of standards for
facilitatingreviewingprocess.Theynolongerarecreatedsolelyforprogrammersconvenient.SDSwillbetreatedas 16
specificationsofdatasetstobesubmitted,potentiallyasreferenceofCRFdesign.Therefore,statisticalprogramming
mayneedtostartfromthiscommonground.Allexistingprograms/macrosmayalsoneedtoberemappedbasedon
CDISC so one can take advantage to validate submission information by using tools which reviewer may use for
reviewingandtoacceleratereviewingprocesswithoutprovidingunnecessarydata,tablesandlistings.Withthenew
requirementsfromupdatingelectronicsubmissionandCDISCimplementation,understandingonlySASmaynotbe
good enough to fulfill for finaldeliverables. It is a time to expand and enhance the job skills from various aspects
undernewchangesothatSASprogrammerscantakeacompetitiveadvantage,andcontinuetoplayamainrolein
bothstatisticalanalysisandreportingfordrugdevelopment.

References:
Pharmasug/2007/fc/fc05
pharmasug/2003/fdacompliance/fda055
1)WhatdoyouunderstandaboutSDTManditsimportance?

SDTMstandsforStandarddataTabulationModel,whichdefinesastandardstructureforstudydatatabulationsthat
aretobesubmittedaspartofaproductapplicationtoaregulatoryauthoritysuchastheUnitedStatesFoodandDrug
Administration(FDA)2.
In July 2004 the Clinical Data Interchange Standards Consortium (CDISC) published standards on the design and
content of clinical trial tabulation data sets, known as the Study Data Tabulation Model (SDTM). According to the
CDISC standard, there are four ways to represent a subject in a clinical study: tabulations, data listings, analysis
datasets,andsubjectprofiles6.

BeforeSDTM:

There are different names for each domain and domains dont have a standard structure. There is no standard
variableslistforeachandeverydomain.

Because of this FDA reviewers always had to take so much pain in understanding themselves with different data,
domainnames and name of the variable in eachanalysisdataset. Reviewers will have spent most of the valuable
timeincleaningupthedataintoastandardformatratherthanreviewingthedatafortheaccuracy.Thisprocesswill
delaythedrugdevelopmentprocessassuch.

AfterSDTM:
There will be standard domain names and standard structure for each domain. There will be a list of standard
variablesandnamesforeachandeverydataset.Becauseofthis,itwillbecomeeasytofindandunderstandthedata
andreviewerswillneedlesstimetoreviewthedatathanthedatawithoutSDTMstandards.Thisprocesswillimprove

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theconsistencyinreviewingthedataanditcanbetimeefficient.

The purpose of creating SDTM domain data sets is to provide Case Report Tabulation (CRT) data FDA, in a
standardized format. If we follow these standards it can greatly reduce the effort necessary for data mapping.
ImproperuseofCDISCstandards,suchasusingavaliddomainorvariablenameincorrectly,canslowthemetadata
mappingprocessandshouldbeavoided4.

2)PROCCDISCforSDTM3.1Format2?
SyntaxThePROCCDISCsyntaxforCDISCSDTMispresentedbelow.TheDATA=parameterspecifiesthelocation
of your SDTM conforming data source.PROC CDISC MODEL=SDTMSDTM SDTMVersion = "3.1"DOMAINDATA
DATA=results.AEDOMAIN=AECATEGORY=EVENTRUN

3)WhatarethecapabilitiesofPROCCDISC2?

PROCCDISCperformsthefollowingchecksondomaincontentofthesource:

Verifiesthatallrequiredvariablesarepresentinthedataset
Reportsasanerroranyvariablesinthedatasetthatarenotdefinedinthedomain
Reportsawarningforanyexpecteddomainvariablesthatarenotinthedataset
Notesanypermitteddomainvariablesthatarenotinthedataset
Verifiesthatalldomainvariablesareoftheexpecteddatatypeandproperlength
Detectsanydomainvariablesthatareassignedacontrolledterminologyspecificationbythedomainanddonothave
aformatassignedtothem.

Theprocedurealsoperformsthefollowingchecksondomaindatacontentofthesourceonaperobservationbasis:

Verifiesthatallrequiredvariablefieldsdonotcontainmissingvalues
Detectsoccurrencesofexpectedvariablefieldsthatcontainmissingvalues
DetectstheconformanceofallISO8601specificationassignedvaluesincludingdate,time,datetime,duration,and
intervaltypes
Notescorrectnessofyes/noandyes/no/nullresponses,

4)WhatarethedifferentapproachesforcreatingtheSDTM3?
Thereare3generalapproachestocreatetheSDTMdatasets:

a)BuildtheSDTMentirelyintheCDMS,
b)BuildtheSDTMentirelyonthebackendinSAS,
c)ortakeahybridapproachandbuildtheSDTMpartiallyintheCDMSandpartiallyinSAS.

BUILDTHESDTMENTIRELYINTHECDMS
It is possible to build the SDTM entirely within the CDMS. If the CDMS allows for broad structural control of the
underlyingdatabase,thenyoucouldbuildyoureCRForCRFbasedclinicaldatabasetoSDTMstandards.

Advantages:
YourrawdatabaseisequivalenttoyourSDTMwhichprovidesthemostelegantsolution.
Yourclinicaldatamanagementstaffwillbeabletoconversewithendusers/sponsorsaboutthedataeasilysince
yourclinicaldatamanagerandtheunduser/sponsorwillbothbelookingatSDTMdatasets.
AssoonastheCDMSdatabaseisbuilt,theSDTMdatasetsareavailable.

Disadvantages:
This approach may be cost prohibitive. Forcing the CDMS to create the SDTM structures may simply be too
cumbersometodoefficiently.
ForcingtheCDMStoadapttotheSDTMmaycauseproblemswiththeoperationoftheCDMSwhichcouldreduce
dataquality.

BUILDTHESDTMENTIRELYONTHEBACKENDINSAS
Assuming that SAS is not your CDMS solution, another approach is to take the clinical data from your CDMS and
manipulateitintotheSDTMwithSASprogramming.

Advantages:
ThegreatflexibilityofSASwillletyoutransformanyproprietaryCDMSstructureintotheSDTM.Youdonothaveto
workaroundtherigidconstraintsoftheCDMS.
ChangescouldbemadetotheSDTMconversionwithoutdisturbingclinicaldatamanagementprocesses.
TheCDMSisallowedtodowhatitdoesbestwhichistoenter,manage,andcleandata.

Disadvantages: There would be additional cost to transform the data from your typical CDMS structure into the
SDTM.
Specifications,programming,andvalidationoftheSASprogrammingtransformationwouldberequired.
OncetheCDMSdatabaseisup,therewouldthenbeasubsequentdelaywhiletheSDTMiscreatedinSAS.

This delay would slow down the production of analysis datasets and reporting. This assumes that you follow the
linearprogressionofCDMS>SDTM>analysisdatasets(ADaM).

SincetheSDTMisaderivationoftherawdata,therecouldbeerrorsintranslationfromtherawCDMSdatato
theSDTM.
Yourclinicaldatamanagementstaffmaybeatadisadvantagewhenspeakingwithendusers/sponsorsaboutthe
datasincethedatamanagerwilllikelybelookingattheCDMSdataandthesponsorwillseeSDTMdata.

BUILDTHESDTMUSINGAHYBRIDAPPROACH
Again,assumingthatSASisnotyourCDMSsolution,youcouldbuildsomeoftheSDTMwithintheconfinesofthe
CDMSanddotherestoftheworkinSAS.TherearethingsthatcouldbedoneeasilyintheCDMSsuchasnaming

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data tables the same as SDTM domains, using SDTM variable names in the CTMS, and performing simple
derivations(suchasage)intheCDMS.MorecomplexSDTMderivationsandmanipulationscanthenbeperformedin
SAS.

Advantages:
ThechangestotheCDMSareeasytoimplement.
TheSDTMconversionstobedoneinSASaremanageableandmuchcanbeautomated.

Disadvantages:
TherewouldstillbesomeadditionalcostneededtotransformthedatafromtheSDTMlikeCDMSstructureintothe
SDTM.Specifications,programming,andvalidationofthetransformationwouldberequired.
TherewouldbesomedelaywhiletheSDTMlikeCDMSdataisconvertedtotheSDTM.
Yourclinicaldatamanagementstaffmaystillhaveaslightdisadvantagewhenspeakingwithendusers/ sponsors
aboutthedatasincetheclinicaldatamanagerwillbelookingattheSDTMlikedataandthesponsorwillseethetrue
SDTMdata.

5)WhatdoyouknowaboutSDTMdomains?

A basic understanding of the SDTM domains, their structure and their interrelations is vital to determining which
domainsyouneedtocreateandinassessingtheleveltowhichyourexistingdataiscompliant.TheSDTMconsists
ofasetofclinicaldatafilespecificationsandunderlyingguidelines.Thesedifferentfilestructuresarereferredtoas
domains. Each domain is designed to contain a particular type of data associated with clinical trials, such as
demographics,vitalsignsoradverseevents.

The CDISC SDTM Implementation Guide provides specifications for 30 domains. The SDTM domains are divided
intosixclasses.

The21clinicaldatadomainsarecontainedinthreeoftheseclasses:
Interventions,
Eventsand
Findings.

Thetrialdesignclasscontainssevendomainsandthespecialpurposeclasscontainstwodomains(Demographics
andComments).

The trial design domainsprovide the reviewer with information on the criteria, structure and scheduled events of a
clinicaltrail.Theonlyrequireddomainisdemographics.

Therearetwootherspecialpurposerelationshipdatasets,theSupplementalQualifiers(SUPPQUAL)datasetand
theRelateRecords(RELREC)dataset.SUPPQUALisahighlynormalizeddatasetthatallowsyoutostorevirtually
any type of information related to one of the domain data sets. SUPPQUAL domain also accommodates variables
longerthan200,theIst200charactersshouldbestoredinthedomainvariableandtheremainingshouldbestoredin
it5.

6)WhatarethegeneralguidelinestoSDTMvariables?

EachoftheSDTMdomainshasacollectionofvariablesassociatedwithit.
Therearefiverolesthatavariablecanhave:
Identifier,
Topic,
Timing,
Qualifier,
andfortrialdesigndomains,

Rule.Usinglabdataasanexample,thesubjectID,domainIDandsequence(e.g.visit)areidentifiers.
Thenameofthelabparameteristhetopic,
thedateandtimeofsamplecollectionaretimingvariables,
theresultisaresultqualifierandthevariablecontainingtheunitsisavariablequalifier.

VariablesthatarecommonacrossdomainsincludethebasicidentifiersstudyID(STUDYID),atwocharacterdomain
ID(DOMAIN)anduniquesubjectID(USUBJID).

In studies with multiple sites that are allowed to assign their own subject identifiers, the site ID and the subject ID
mustbecombinedtoformUSUBJID.
Prefixing a standard variable name fragment with the twocharacter domain ID generally forms all other variable
names.

TheSDTMspecificationsdonotrequireallofthevariablesassociatedwithadomaintobeincludedinasubmission.
InregardtocomplyingwiththeSDTMstandards,theimplementationguidespecifieseachvariableasbeingincluded
inoneofthreecategories:

Required,Expected,andPermitted4.

REQUIREDThesevariablesarenecessaryfortheproperfunctioningofstandardsoftwaretoolsusedbyreviewers.
Theymustbeincludedinthedatasetstructureandshouldnothaveamissingvalueforanyobservation.

EXPECTEDThesevariablesmustbeincludedinthedatasetstructurehoweveritispermissibletohavemissing
values.

PERMISSIBLEThesevariablesarenotarequiredpartofthedomainandtheyshouldnotbeincludedinthedata

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setstructureiftheinformationtheyweredesignedtocontainwasnotcollected.

7)CanyoutellmemoreAboutSDTMDomains5?
SDTMDomainsaregroupedbyclasses,whichisusefulforproducingmoremeaningfulrelationalschemas.Consider
thefollowingdomainclassesandtheirrespectivedomains.

SpecialPurposeClassPertainstouniquedomainsconcerningdetailedinformationaboutthesubjectsinastudy.

Demography(DM),Comments(CM)

FindingsClassCollectedinformationresultingfromaplannedevaluationtoaddressspecificquestionsaboutthe
subject,suchaswhetherasubjectissuitabletoparticipateorcontinueinastudy.

Electrocardiogram(EG)
Inclusion/Exclusion(IE)
LabResults(LB)
PhysicalExamination(PE)
Questionnaire(QS)
SubjectCharacteristics(SC)
VitalSigns(VS)

EventsClassIncidentsindependentofthestudythathappentothesubjectduringthelifetimeofthestudy.

AdverseEvents(AE)
PatientDisposition(DS)
MedicalHistory(MH)

Interventions Class Treatments and procedures that are intentionally administered to the subject, such as
treatmentcoincidentwiththestudyperiod,perprotocol,orselfadministered(e.g.,alcoholandtobaccouse).

ConcomitantMedications(CM)
ExposuretoTreatmentDrug(EX)
SubstanceUsage(SU)

TrialDesignClassInformationaboutthedesignoftheclinicaltrial(e.g.,crossovertrial,treatmentarms)including
informationaboutthesubjectswithrespecttotreatmentandvisits.

SubjectElements(SE)
SubjectVisits(SV)
TrialArms(TA)
TrialElements(TE)
TrialInclusion/ExclusionCriteria(TI)

TrialVisits(TV)

7)CanyoutellmehowtodotheMappingforexistingDomains?
First step is the comparison of metadata with the SDTM domain metadata. If the data getting from the data
managementisinsomewhatcompliancetoSDTMmetadata,useautomatedmappingastheIststep.

IfthedatamanagementmetadataisnotincompliancewithSDTMthenavoidautomapping.Sodomanualmapping
thedatasetstoSDTMdatasetsandthemappingeachvariabletoappropriatedomain.

Thewholeprocessofmappinginclude:*Readinthecorporatedatastandardsintoadatabasetable.
AssignaCDISCdomainprefixtoeachdatabasemodule.
AttachacomboboxcontainingtheSDTMvariablefortheselecteddomaintoanewmappingvariablefield.
Searcheachmodule,andwithineachmoduleselectthemostappropriateCDISCvariable.
Then search for variables mapped to the wrong type Character not equal to Character Numeric not equal to
Numeric.
Reviewthemappingtoseeifanyconflictsareresolvablebymappingtoamoreappropriatevariable.
Weneedtoverifythatthemappedvariableisappropriateforeachrole.
Thenfinallywehavetoensureallrequiredvariablesarepresentinthedomain6.

8)WhatdoyouknowaboutSDTMImplementationGuide,Haveyouusedit,ifyouhavecanyoutellmewhich
versionyouhaveusedsofar?
SDTM Implementation guide provides documentation on metadata (data of data) for the domain datasets that
includes filename, variable names, type of variables and its labels etc. I have used SDTM implementation guide
versions3.1.1/3.1.2

9)Canyouidentifywhichvariablesshouldwehavetoincludeineachdomain?
A)SDTMimplementationguideV3.1.1/V3.1.2specifieseachvariableisbeingincludedinoneofthe3types.
REQUIRED They must be included in the data set structure and should not have a missing value for any
observation.

EXPECTEDThesevariablesmustbeincludedinthedatasethoweveritispermissibletohavemissingvalues.

PERMISSIBLEThesevariablesarenotarequiredpartofthedomainandtheyshouldnotbeincludedinthedata
setstructureiftheinformationtheyweredesignedtocontainwasnotcollected.

10)CanyougivesomeexamplesforMAPPING*6?

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HerearesomeexamplesforSDTMmapping:
CharactervariablesdefinedasNumeric
NumericVariablesdefinedasCharacter
Variables collected without an obvious corresponding domain in the CDISC SDTM mapping. So must go into
SUPPQUAL
SeveralcorporatemodulesthatmaptoonecorrespondingdomaininCDISCSDTM.
CoreSDTMisasubsetoftheexistingcorporatestandards
VerticalversusHorizontalstructure,(e.g.Vitals)
Datescombiningdateandtimespartialdates.
Datacollapsingissuese.g.AdverseEventsandConcomitantMedications.
AdverseEventsmaximumintensity
Metadataneededtolaboratorydatastandardization.

10)ExplaintheProcessofSDTMMapping?

Alistofbasicvariablemappingsisgivenbelow*4.

DIRECT:aCDMvariableiscopieddirectlytoadomainvariablewithoutanychangesotherthanassigningtheCDISC
standardlabel.
RENAME:onlythevariablenameandlabelmaychangebutthecontentsremainthesame.
STANDARDIZE:mappingreportedvaluestostandardunitsorstandardterminology
REFORMAT:theactualvaluebeingrepresenteddoesnotchange,onlytheformatinwhichisstoredchanges,such
asconvertingaSASdatetoanISO8601formatcharacterstring.
COMBINING:directlycombiningtwoormoreCDMvariablestoformasingleSDTMvariable.
SPLITTING:aCDMvariableisdividedintotwoormoreSDTMvariables.
DERIVATION:creatingadomainvariablebasedonacomputation,algorithm,seriesoflogicrulesordecodingusing
oneormoreCDMvariables.

11)WhataretheCommonIssuesinMappingDummycorporatestandardstoCDISC(SDTM)Standards?

CharactervariablesdefinedasNumeric
NumericVariablesdefinedasCharacter
Variables collected without an obvious corresponding domain in the CDISC SDTM mapping. So must go into
SUPPQUAL
SeveralcorporatemodulesthatmaptoonecorrespondingdomaininCDISCSDTM.
DictionarycodesnotinSDTMparentmodule,soifneededmustbecollectedinSUPPQUAL.
CoreSDTMisasubsetoftheexistingcorporatestandards
DifferentstructureofLabCDISCDomaine.g.baselineflag.
VerticalversusHorizontalstructure,(e.g.Vitals)
AdditionalMetadataneededtodescribethesourceinSUPPQUAL
Datescombiningdateandtimespartialdates.
Datacollapsingissuese.g.AdverseEventsandConcomitantMedications.
AdverseEventsmaximumintensity
Metadataneededtolaboratorydatastandardization.

Ref:MappingCorporateDataStandardstotheCDISCModel(SASPaper)byDavidParker,AstraZeneca,Manchester,UnitedKingdom

The Analysis Data Model describes the general structure, metadata, and content
typically found in Analysis Datasets and accompanying documentation. The three
types of metadata associated with analysis datasets (analysis dataset metadata,
analysis variable metadata, and analysis results metadata) are described and
examplesprovided.(source:CDISCAnalysisDataModel:Version2.0)
Analysis datasets (AD) are typically developed from the collected clinical trial data
andusedtocreatestatisticalsummariesofefficacyandsafetydata.TheseADsare
characterized by the creation of derived analysis variables and/or records. These
derived data may represent a statistical calculation of an important outcome
measure,suchaschangefrombaseline,ormayrepresentthelastobservationfora
subject while under therapy. As such, these datasets are one of the types of data
senttotheregulatoryagencysuchasFDA.

TheCDISCAnalysisDataModel(ADaM)definesastandardforAnalysisDatasets
tobesubmittedtotheregulatoryagency.Thisprovidesaclearcontent,source,and
quality of the datasets submitted in support of the statistical analysis performed by
thesponsor.

InADaM,thedescriptionsoftheADsbuildonthenomenclatureoftheSDTMwith
the addition of attributes, variables and data structures needed for statistical
analyses. To achieve the principle of clear and unambiguous communication relies
on clear AD documentation. This documentation provides the link between the

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general description of the analysis found in the protocol or statistical analysis plan
andthesourcedata.
12)CanyouexplainAdaMorAdaMdatasets*7?

References:
1)http://support.sas.com/rnd/base/xmlengine/proccdisc/cdiscsdtm.html
2)http://www.fda.gov
3)pharmasug/2005/fdacompliance/fc01.pdf
4)http://www2.sas.com/proceedings/forum2008/2072008.pdf
5)http://analytics.ncsu.edu/sesug/2006/PO08_06.PDF
6)http://www.lexjansen.com/phuse/2005/cd/cd11.pdf
7)http://www.pharmasug.org/2005/FC03.pdf

Apartfromthose..youmayalsoneedtoprepareforthesequestionstoo...

RobertStemplinger:

1)HowmanyyearsexperienceyouhaveworkingwithCDISCstandards?

2)WhathaveyoubeendoneasperCDISCstandards.

(TellmetheusuallprocessflowortheprocedureyouhavefollowedregardingimplementationofCDISCstandards)

3)ForhowmanystudiessofaryouhavedoneSDTMmapping.

4)HaveyoueverbeenaskedtocreatespecificationsforSDTMmapping.

Ifyes,howdoyoucreatespecificationdocumentformapping.

5)Doyouhaveexperiencedoingthemappingasperthesponsorstandards.

6)a)Tellmefewdetailsaboutthedatabasesyouhaveworkedwithsofar?

b)Whichdatabasedoyouthinkyouhadmosttroublewith?(Inform,Rave,ClintrialorOracleclinical)

7)Howdoyouvalidate

a)annotatedCRF

b)SpecificationDocument

c)SDTMdatasets

d)CaseReportTabulations(CRTDDS)

8)a)HowdoyouverifyallthestandardshasbeenmaintainedaspertheSDTMimplementationguide?

b)HowdoyouperformvalidationchecksonSDTMv3.1.1or3.1.2datasets?(WEBSDM/OpenCDISCorPROC
CDISC)?

9)Whatyouwilldowhenyoufindaproblemaspartofthevalidationprocess?

10)WhatkindofmacrosyouhavedevelopedwhichcanbeusefulincreatingSDTMstandarddatasets?

11)Doyouliketocreateasingleprogramforeachdomainandthenincludeinabatchprogramor

justonebigprogramforallthedomains.

12)Doyouhaveanyexperiencetalkingtotheclientonregularbasis?If,yes...sharewithmeyourexperience?

13)Doyouhaveexperienceworkingwithpeopleindifferenttimezone?

14)DoyouhaveexperienceorknowledgeaboutWEBSDMchecksorOpenCDISC?

15)DoyouknowPROCCDISC?

16)HowdoyoucreateDefinefile(XMLorPDF),ifyoualreadyhadexperiencecreatingone?

17)Ifyouareworkingasavalidator,howdoyoucommunicatewiththemainprogrammer?

18)HowmanyweekstimeyouthinkyouneedtofinishcreatingtheSDTMdatasets?(Justforprogramming)?

Howmanyweeks,ifyoualsobeenaskedtodevelopspecifications?

19)Isthereanysampleprogramyoucanwriteorshow...whichwillgiveusanideaaboutyouSASprogramming

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skills?

20)What'sthechallengingpartregardingthewholeSDTMmappingprocess?

21)Forwhichdomaindoyouthinkyoualwaysneedtobeverycareful?andwhy?

22)IfIaskyoutocreateSDTMmappingspecificationdocument?whatdocumentsorfilesyouneedandwhy?

23) Do you know anything about splitting domains. (or Can you split the domains rather than creating one big
domain)?

24)Whatisvaluelevelmetadata?

25)Whatdoyouknowaboutcontrolledterminologyandforwhichdomainsyouneedcontrolledterminology?

26)WhatareRELRECandSUPPQUALdomains.

27)Canyousharewithmeanydifferencesyouknowbetweenimplementationguidev3.1.1andv3.1.2?

28) How do you determine the time line, If the client asked you to provide one for the SDTM mapping conversion
process?

29)IsthereanywaytoapplyattributestotheSDTMvariablesotherthanjustmanuallytypingallthedetailsabout
(length/label/format/informatetc)inanattribstatement?

30)Youhavebeenaskedtocreateadomain(notincludedinimplmentationguide)forCRF,whatyouwilldoorhow
doyoucreateone?

Herearefewmorequestions.....exclusivetoSDTMMapping....

CDISCSDTMQuestionsYoumightbeaskedinaninterview
1)HaveyouusedSTATvariableanytime.Ifyes,whyandinwhatkindofdomainyouusedthatvariable.
2)IseeinyourCVthatyouhaveexperienceindevelopingSDTMdomainsbasedonIG3.1.1,V3.1.2andV3.1.3.Can
you share some of the differences between each version of Implementation Guide? (Difference between SDTM IG
3.1.1vs.V3.1.2andV3.1.2vs.V3.1.3)
3)Canyougivemeanexampleofavariablewhichcanbeusedtogroupsomeoftherecords?
4)TellmeyourexperienceusingSPECvariable.
5)WhatsthesignificanceofPRESPvariableandtellmewhatdoyouknowaboutOCCURvariable.
6)CanyougivemeanexampleofaTopicVariablein:
a)InterventionDomains
b)EventDomains
c)FindingDomains
7) WhatsyourexperiencecreatingtheRelatedRecordsdomain(RELREC)?Canyougivemefewexamplesofthe
domainsyouveusedtocreateaRELRECSDTMdomain?
8)WhatsyourexperiencecreatingtheFindingsAbout(FA)andClinicalEvents(CE)domains.
WhatsthedifferencebetweentheFAandCEdomains?
9)CanyougivemefewexamplesofthekindofdatayouaregoingtomapittoFAandCEdomains.
10)WhycantweincludeClinicalEventdatainAEdomain?
11) Whatsyourexperiencecreatingthecustomdomains?Howdoyoucreateacustomdomain?
12) Whatyoudo,ifyouhaveaCRFpageandalloftheinformationcollectedonitarentrelatedtoanyspecificSDTM
domain.
13)WhendoyoucreateaSUPPQUALorCustomdomain?
14)Ifyouhaveanyexperiencecreatingacustomdomain,canyoushare,whatkindofthedatathatwasandwhatsthe
PREFIXyouhaveusedforthedomainname.
15)TellmeaboutthedifficultthingyouhavetodoormanagewhenyouworkasaSDTMstandardsimplementer.
16)HaveyouuseOBJvariable.Ifyouare,inwhichdomain?Andwhatsthesignificance.
17)TellmeaboutRequired/ExpectedorPermissiblevariablesinSDTMdomains.
18)HaveyoucreatedanyTumorDomains?Canyougiveusefewexamplesofthetumordomainsyouhavecreated.

Youmightalsolike:

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