becoming a ccdm...tuesday october 1, 2019 meredith nahmzozus, phd, ccdm ... personnel mgt. 3 0 0...
Post on 20-Mar-2020
4 Views
Preview:
TRANSCRIPT
Becoming a CCDMSession 33, SCDM Annual Meeting
Tuesday October 1, 2019
Meredith Nahm Zozus, PhD, CCDM
Professor and Director, Clinical Research Informatics
Department of Population Health Sciences
UT Health San Antonio
Long School of Medicine
SCDM Certification Program Goals
• Establish and promote professional practice standards throughout clinical data management
• Identify qualified professionals within the profession
• Ensure recognition of expertise
• Enhance the credibility and image of the profession
Certification Exam permits candidates to demonstrate the competencies
identified by SCDM as important in the practice of Clinical Data
Management.
Knowledge Structure of the
CCDMTM Exam
Exam item
Foundational knowledge topic
(cited source)
Research setting; type of data
(application context)
CCDMCompetency
Competency domain
Practice standards
(cited source)
Practice standards are ideally but not always supported by
foundational knowledge.
Certification
Handbook
GCDMP
Certification
Handbook
Types of Data Managed Today and in the Future
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Other
Reference data
Metadata
Enterprise project / program management data
Social media data
Biospecimen / sample acquisition and tracking
Electronic documents
Commercial/public data e.g., death index
Clinical images
Electronic health record (EHR) data
Data from medical devices
Data from personal wearable devices
Data from home monitoring devices
Site payment / site milestone data
Data from central reading centers, e.g., ECG core lab
Other central “Core” Labs
Genomic, proteomic, metabalomic data
External clinical lab data
Patient reported data (PRO/ePRO)
Clinical data from CRFs
Future 2018
Today 2018
0 50 100 150 200 250 300
Other
Commercial/public data e.g.,…
Clinical images
Electronic health record…
Data from medical devices
Data from personal…
Data from home monitoring…
Site payment / site…
Data from central reading…
Other central “Core” Labs
Genomic, proteomic,…
External clinical lab data
Patient reported data…
Clinical data from CRFs
Today
Future
2015
2018
Exam items must cover aspects of CDM relevant to the profession, and be important to the work of the profession Thus exam items are written for the CDM Professional competencies.
This is how CDM
Professional
competencies are
maintained.
A lot of work has gone
into their development
to assure that they are:
1. comprehensive,
2. relevant and
3. logically consistent
Exam items must be concise, easy to read, and grammatically correct.
• Items are drafted by experts (CCDM®)
• Item writers receive training and follow an item writing manual
• Items undergo Psychometric review
• Items undergo technical review and are reviewed again if changed in technical review
Draft items Technical
Review
Added to
item bankPsychometric
ReviewWritten by
GCDMP
Chapter
writing
groups and
CCDMs Reviewed by professionals or
Education and Psychometrics
Reviewed, debated and
improved by CCDMs
Monitored
and
Deprecated
1. Everyone involved signs a CDA
2. Test takers sign a CDA
3. No one outside of SCDM staff sees a
significant percentage of the exam items
If applicants ask you about questions, they are violating the CDA and SCDM Code of Ethics.
If individuals share information about questions with you, they are violating the SCDM
Code of Ethics.
Either of these are really bad in an industry that has such impact of the lives of individuals
and populations.
To exam is proctored and monitored by computers and humans.
Exam
Applicationof
knowledge
Comprehensionof
conceptsandprinciples
Recallofknowledge
Figurefrom:Anderson,L.W.andKrathwohl,D.R.,etal(Eds..)(2001)ATaxonomyfor
Learning,Teaching,andAssessing:ARevisionofBloom’sTaxonomyofEducational
Objectives.Allyn&Bacon.Boston,MA(PearsonEducationGroup)1
All exam questions are
labeled according to
cognitive level using
Bloom’s Taxonomy.
Questions are categorized
as:
• Recall,
• Comprehension or
• Application.
Exam Level of Difficulty
Exam Level
Exam tests higher-level cognitive skills, i.e., that a
candidate can apply foundational knowledge to function
as a competent Data Manager.
Many questions put the candidate in a CDM situation
doing something: • Selecting appropriate method
• Making a decision
• Choosing a structure that fits data
Comprehension
Application
Recall
Question Format
• All CCDM® exam questions are multiple choice questions.
• Each exam question has four answer options, one of which is the correct answer.
• Questions often instruct the test taker to “select the best option”, or to, “select the option that best describes…”. Best is defined as according to regulation, minimum standards, regulatory guidance, and best practices.
Foundational Knowledge
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Therapeutic development fundamentals
Clinical research fundamentals
Scientific method
Introductory-level statistics
FDA regulation and guidance
EU/MHRA regulations
HIPPA regulations
Common rule
ICH Guidance
Audit fundamentals
FDA Bioresearch Monitoring procedures
Quality Management System principles
Project management fundamentals
Principles of managing research data
Data lifecycle concepts
Data quality fundamentals
Relational database concepts
Data governance fundamentals
Data standards in clinical research
Software Development Lifecycle (SDLC)
Human Computer Interaction (HCI)
Workflow analysis and design fundamental
Process control findamentals
Systems Theory and Thinking
Self-learns new theraoeutic areas
Biomedical terminology and concepts
Stongly agree Agree Neutral Disagree Strongly disagree
Foundational Knowledge
is knowledge required to
function as a CDM
professional.
Foundational knowledge
is surveyed with the
competencies.
Source: 2018 CDM Task Analysis Survey
Distribution of Questions on the ExamPlans change! Rely ONLY on the Certification Handbook for this information.
Competency Domain Total CompetenciesCompetencies Tested on
the CCDM® Exam
Exam Questions per
Form
Design 21 19 38 (30%)
Programming 8 1 5 (4%)
Data Processing 16 15 30 (26%)
Testing 2 2 10 (9%)
Training 2 2 5 (4%)
Personnel Mgt. 3 0 0
Project Mgt. of CDM 16 11 22 (22%)
Review 3 2 5 (4%)
Total: 71 52 115
Unscored items* 35*this works differently for the Beta Exam.
Be Honest With Yourself
• Use a Self Assessment Tool: rate yourself on each competency, e.g.,
Write and maintain Data Management Plans
(0) I don't know what this is
(1) I have heard of this but never done it
(2) I have limited experience with this such as I have done this once or in training
(3) I am competent doing this by myself
(4) I am an expert in this and could teach it to someone
• Average items by domain
Full List of CCDM® Professional Competencies
DesignTasks(21Competencies)
D.1.Identifydatatobecollected
a.Identifiesdatatobecollectedforastudyfromstudydesigndocumentssuchasaprotocolandstudyscheduleof
events
b.Relatesstudyhypothesesandendpointstodatacollectionneeds;identifiescriticaldataelementsusedforanalysis
andreporting.
c.Identifiescontextualdataelementsnecessaryforinterpretationofstudydata.Forexample,gender,sample
collectiondateandlabnormalrangesforlabdata.
d.Identifiesdataelementsforwhichmultipleoperationalizationsexistandpromptsstudy-teamdecisionofwhichto
use
e.Leveragesdataelementrepositoriesandrelevantongoingorcompletedstudiestoinformdataelementchoice
D.2.Definestudydataelements
a.Draftsclearstudy-acceptedconceptualandoperationaldefinitionsfordataelements
b.Determinesanddocumentswhetherthedataelementisenumerated(discrete)
c.Documentsdatatypeforstudydataelements
d.Documentsvalidvaluesforenumeratedandnonenumerateddataelements
e.Definesanddocumentsvalidvaluedefinitionsfordiscretedataelements
f.Definesdatacollectionstructure,e.g.,radiobuttons,drop-downlist,semi-structuredwrite-in,freetext,etc.,
appropriateforthedataelement
g.Associatesthedataelementwithdataelementorcontrolledterminologystandardsused
D.3.Designdatacollectionforms
a.RelatesprotocoltoCRFdesignandensuresthatdesignsupportsdataanalysisandreportingrequirements.
b.CollaborateswithteammemberstoensureallneedsaremetbytheCRFdesign.
c.ExplainshowdatarecordedontheCRFarestoredinthedatabaseincludingtheirrelationshiptootherdata.
d.Createseffective/efficientnewCRFdesignsfromnewdatatypesdefinedbyprotocol.
e.Identifiesdatacollectionthatwillrequirenon-standardprogramming.
Competencies
Using the GCDMP As a Study Guide
• Yes, with caution
• There has been a concerted effort to align GCDMP, education and certification. BUT – we are not done.
• Chapter writing groups provide draft certification exam items.
• Education committee has added draft chapter webinars, collaborates on chapter learning objectives and based on need will consider future educational topics.
• In the future these will become better aligned
• IMPORTANT: • GCDMP will not comprehensively cover Foundational Knowledge
• GCDMP is a practice standard, it does not teach skills or provide experience
CCDM® Foundational Knowledge Topics
Therapeuticdevelopmentfundamentals:Topicsincludepre-clinicaldevelopment,phasesoftrialsinclinicaldevelopment,
post-marketingandseedingregistriesandstudies.Knowledgeoftherapeuticdevelopmentisexpectedattheconceptuallevelfor
clinicalresearchacrossdrugs,biologicsanddevices.
Clinicalresearchfundamentals:TopicsincludeGoodClinicalPractice,humansubjectsprotection,thedefinitionofclinical
research,studydesignsandtypesusedacrosstheresearchspectrum,allocation(randomization)ofsubjectsandelementsof
control(placeboorothercontrol,blinding).ProfessionalClinicalDataManagersareexpectedtoapplyknowledgeofclinical
researchfundamentalstodesignandcontrolcollectionandmanagementofdataforclinicalstudies.
Scientificmethod:Topicsincludethepurposeandelementsofscientificmethod.Knowledgeofscientificmethodisexpectedat
theconceptuallevel.
Introductory-levelstatistics:Theclinicaldatamanagershouldbefamiliarwithmeasuresofcentraltendencyanddispersion
includingmean,median,mode,range,maximumandminimum,quartiles,deciles,varianceandstandarddeviation.TheCDM
shouldunderstandthereasonsforsignificancetesting,therelationshipbetweensamplesize,powerandeffectsize,andthe
rationaleforrandomization,blinding,correctingformultiplecomparisons,andcontrollingforconfounding,outliersandbias.The
CDMshouldbeabletorelatetheseconceptstomethodologyselection,riskidentificationandproblemsencounteredincollection
andmanagementofdataforclinicalstudies.
FDAregulation&guidance:TheCDMshouldunderstandwhere(towhattypesofstudies)thefollowingregulationsapply,and
thepurposeofeachregulation:
Title21CFRPart50and56
Title21CFRPart11
Title21CFRPart312and314
Title21CFRPart800’s
TheCDMshouldbefamiliarwithFDAregulationandguidancerelevanttoDataManagementandthepurposeandthemainideas
ofeach.RelevantregulationandguidanceiscitedintheGCDMPandmayincludethefollowing:ICHE6R2,ComputerSystems
UsedinClinicalTrials(CSUCT),ePRO,eSource,useofEHRsinclinicalstudies,andrisk-basedmonitoring.Thebestsourcefor
eachistheactualregulationandguidance.
HIPAAregulations:TheCDMshouldunderstandwheretheHIPAAregulations(Title45CFR160,162,and164)apply,andtheir
purpose.Thebestsourceforeachistheactualregulationandguidance.
Commonrule:TheCDMshouldunderstandwherethecommonrule(Title45CFRpart46)appliesanditspurpose.Thebest
sourceforeachistheactualregulationandguidance.
Auditmethodologyfundamentals:TheCDMshouldbefamiliarwithprocessesforqualityauditplanning,conduct,reporting
andresponsetoauditfindings.Anauthoritativesourceforthisinformationis:TheQualityAuditHandbookbytheASQQuality
AuditDivisionandJ.P.Russell(Editor).
FDABioreserachMonitoringprocedures:TopicsincludeproceduresthattheFDAusesfortheconductofinspectionaland
investigationalactivities.TheCDMshouldbefamiliarwithFDAproceduresforinspectionandforFDAcategorizationoffindings.
TheauthoritativesourceistheComplianceProgramGuidanceManuals(CPGM)availablefrom
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm160670.htm
Qualitymanagementsystemprinciples:Topicsincludequalitymanagementsystemfundamentalconceptsandprinciplesas
describedintheISO9000standard,andqualitymanagementsystemcomponentsappliedtoClinicalDataManagement.Quality
managementsystemprinciplesareappliedbyICHE6R2toclinicalstudiesingeneral,andtoClinicalDataManagement
specificallyintheAssuringDataQualitychapterintheGCDMP.Theauthoritativesourceforgeneralqualitymanagementsystem
informationistheISO9000seriesofstandards.CDMswillbenefitfromtheconceptual-levelinformationinthestandardISO
9000,Qualitymanagementsystems-Fundamentalsandvocabulary.TheCDMshouldbeabletoapplyQMSprinciplestodesign
andcontrolofprocessesusedinthecollectionandmanagementofdataforclinicalstudies.
WorkflowDesign,Analysis,andControlfundamentals:Workflowdesign,analysis,andcontrolfundamentalsincludea
systemsandcontroltheoryapproachtoprocesswherebyaprocessisviewedasasystemwithinputsandoutputs,theoutputs
canbemeasuredandthemeasurementsusedasfeedbacktocontroltheprocess,i.e.,produceoutputofconsistentquality.
Processcontrolfundamentalsareappliedindesignandmanagementofworkflowanddataflowinclinicaldatamanagementwith
automationforefficiencyanderrorpreventionasasignificantcomponent.TheDataBook(M.N.Zozus,2017)allocatesachapter
toworkflowanddataflowappliedtocollectionandmanagementofresearchdata.
Metadatadefinitionandmanagement:Topicsincludedatadefinition,dataelements,anddataprovenance.Goodsourcesfor
thisinformationinclude:
1. ChisholmMD.,DefinitionsinInformationManagement:AGuidetotheFundamentalSemanticMetadata.Canada:Design
Media;2010.
2. M.N.Zozus,TheDataBook,Taylor&Francis/CRCPress,2017.
3. InternationalOrganizationforStandardizationandtheInternationalElectrotechnicalCommission.InternationalStandard
ISO/IEC11179-1:2004(E)Informationtechnology—Metadataregistries(MDR)—Part1:Framework.
Fundamentalprinciplesofmanagingresearchdata:includethefundamentaltypesofdata,relativetimingofdatacollection
andprocessing,andthewaysthatdatamove,changeandgrowinthecontextofresearch.TheCDMshouldbeabletoapplythese
principlestoselectingthebestmethods,tools,workflowanddataflowdesignoptionsforclinicalstudies.Asourceforthis
informationis:ZozusM,TheDataBook(2017).
Datalifecycleconcepts:Datalifecycleconceptsincludethestagesthroughwhichdatapassfromorigination,includingdata
changesandultimatelyfinaldisposalandconsiderationsformanagementofdataateachstage.TheCDMshouldbeabletoapply
theseconceptstoselectingthebestmethods,tools,workflowanddataflowdesignoptionsforclinicalstudies.Agoodsourceof
informationforthistopicis:JourneytoDataQualitybyLee,Pipino,Funk,andWang,MITPress,2009.
Dataqualityfundamentals:Topicsincludedimensionsofdataquality,assuringdataquality,causesofdataqualityproblems,
measuringdataquality,andcontrollingdataquality.TheCDMshouldbeabletodesignmethods,tools,workflowanddataflow
thatassurethatdataareofsufficientqualitytosupportconclusionsdrawnfromthem.MeasuringandAssuringDataQualityare
appliedtoCDMandcoveredintheGCDMPchaptersbythesamenames.Agoodsourceofinformationfordataqualityingeneral
is:JourneytoDataQualitybyLee,Pipino,Funk,andWang,MITPress,2009.
Relationaldatabaseconcepts:TheCDMshouldbeabletolookatadatacollectionformorscreenandbeabletodescribea
relationallycorrecttabletostoretheindicateddataandtodescribenecessaryreferentialintegritytorelateddatainothertables.
TheCDMshouldbeabletowriteANSIstandardSQLcodeequivalenttothatinanintroductoryrelationaldatabasecourseupto
butNOTincludingPLSQL.Thebestsourceforthisinformationisanintroductoryrelationaldatabasebook.
Softwaredevelopmentlifecycleconcepts:TheCDMshouldunderstandthestepsusedinsoftwaredevelopment,e.g.,
specificationofrequirements,design,development,andtesting,includingtherelationshipofthesecommonstepstosoftware
validation.TheCDMshouldunderstandconceptualdifferencesbetweenwaterfallandagilemethodsforsoftwaredevelopment,
andbeabletoapplyconceptsfromTitle21CFRPart11tothem.TheCDMshouldbeabletodifferentiatebetweenrequirements
needingsoftwaredevelopmentversusthoserequiringconfigurationwithinexistingsoftware.SoftwareDevelopmentLifecycle
(SDLC)alsoincludesselectionandimplementationofpurchasedoropensourcesoftware.Agoodsourceforthisinformationis
theFDAGuidanceonComputerSystemsUsedinClinicalTrialsandtheFDAguidanceonvalidation.Agoodbasicbookon
fundamentalsofsoftwaredesignanddevelopmentisRodStephens’bookBeginningSoftwareEngineering1stEdition.Wileyand
Sons,2015.
CommonDataModelStandardsUsedinClinicalResearch:TheCDMshouldbefamiliarwiththefollowingmainstreamdata
modelsusedinclinicalstudies,thetypesofresearchthemodelwasdesignedtosupport,thestewardingorganization,andthe
datacontentcoveredbythemodel.CommondatamodelsincludetheObservationalMedicalOutcomesPartnership(OMOP)
model,thePatientCenteredOutcomesResearchNetwork(PCORnet)datamodel,theSentineldatamodel,andtheClinicalData
InterchangeStandardsConsortium(CDISC)SubmissionDataTabulationModel(SDTM).TheCDMshouldalsobefamiliarwithany
standardcontrolledterminologiessupportedorusedbyeachmodel.Thebestsourceofinformationaboutcommondatamodels
isthewebsitefortheorganizationstewardingormaintainingthecommondatamodelstandard.Commondatamodelscommonly
usedinclinicalresearch(CDISCSDTM,OMOP,PCORnet)arealsocoveredintheSCDMon-lineDataStandardscourse.
DataelementstandardsUsedinClinicalResearch:TheCDMshouldbefamiliarwithresourceswhereexistinganddeveloping
dataelementstandardscanbefoundandbeabletousestandarddataelementresourcestoinformdatacollectionforastudy.
Publicrepositoriesofstandarddataelementsinclude:
NationalLibraryofMedicine(NLM)CommonDataElementPortal(https://www.nlm.nih.gov/cde/)
NationalCancerInstitute(NCI)CancerDataStandardsRepository(https://cdebrowser.nci.nih.gov/CDEBrowser/)
AgencyforHealthcareQualityandResearch(AHRQ)UnitedStatesHealthInformationKnowledgeRepository(USHIK)
(https://ushik.ahrq.gov/)repositories,HealthLevelSeven(HL7),
FDAstandarddataelements(FDACDERDataStandardsProgramwebsite)
CDISCTherapeuticareaandCDASHdatastandards(http://www.cdisc.org/cdisc-share)
HealthLevelSevenstandardDomainAnalysisModels(http://www.hl7.org)
StandarddataelementsetsandresourcescommonlyusedinclinicalresearcharealsocoveredintheSCDMon-lineData
Standardscourse.
ControlledTerminologyStandardsUsedinClinicalResearch:TheCDMshouldbefamiliarwiththestandardcontrolled
terminologiesusedinclinicalresearchandbeabletocompareandcontrastvocabularies/terminologies,taxonomies,and
ontologies.Foreachofthefollowingcontrolledterminologies,taxonomiesandontologies,theCDMshouldbefamiliarwiththeir
scopeorcontentcoverage,theirstructure,andthetypesofstudiestowhichtheyarecommonlyapplied.Controlledterminologies
ofinterestinclude:MedDRA,WHODRUG,LOINC,ClinicalLOINC,SMOMED,ICD,CPT,RxNORM,andNDT-RT.Thebestsourceof
informationaboutcontrolledterminologyisthewebsitefortheorganizationstewardingormaintainingthestandard.Controlled
terminologiescommonlyusedinclinicalresearcharealsocoveredintheSCDMon-lineDataStandardscourse.
DataExchangeStandardsusedinClinicalResearch:TheCDMshouldbefamiliarwithdataexchangestandardsusedinclinical
researchincludingtheIndividualCaseSafetyReport(ICSR),theStructuredProductLabel(SPL),theAnnotatedECGWaveform
standards(aECG),andtheOperationalDataModel(ODM).Foreachstandard,theCDMshouldbeabletoarticulatethepurposeof
thestandard,thescopeorcontentcoverage,andthedataexchangescenarioorusecasethatthestandardwasdesignedto
support.Thebestsourceofinformationaboutcontrolledterminologyisthewebsitefortheorganizationstewardingor
maintainingthestandard.DataexchangestandardscommonlyusedinclinicalresearcharealsocoveredintheSCDMon-lineData
Standardscourse.
• Application processed w/in 14 days
• Applicant receives an email:
• Disposition will be acceptance, denial, or a request for further information.
• In the case of acceptance, email will include an eligibility ID required to schedule your exam.
• You will have 90 days from the date of your acceptance email to take your exam.
• The “90 days” is referred to as your eligibility period.
Application Processing
Exam Administration
• The exam will be administered via the internet (Test.com)
• The exam is timed, limited at 3.5 hours
• Exam is proctored through continuous video.
• Cut score is established through formal psychometrics
• Starting 2019, unscored items will be added to the exam to test them for future use.
Exam Scoring
• Regular exam pretty fast
• Beta Exam pretty slow
• Can’t run analysis to determine the statistics until
1. We have met recruitment AND
2. The “database is locked”
• We reserve a month for analysis and cur score determination
• Then result are mailed
• If you pass the Beta then you are a CCDM !
Which of the following is the best choice for a Data Manager is
preparing for the CCDM® Exam and considering using the
GCDMP as a Study Guide?
A. Use the GCDMP as the only study guide
B. Use the GCDMP as a primary study guide along with other resources
C. Use the GCDMP equally with the corpus of data management books available
D. Don’t use the GCDMP
A Data Manager is preparing for the CCDM® Exam. Which of
the following is the best source for the list of CCDM®
Professional Competencies?
A. The GCDMP
B. Title 21 CFR
C. Data management books
D. Certification handbook
A Data Management leader is helping others prepare for the
CCDM® Exam. Which of the following is the best first step?
A. Self assessment against the CDM competencies
B. Thorough review of FDA regulation and guidance
C. Completing a graduate certificate in informatics
D. Listening to recorded SCDM educational webinars
Which of the following is a violation of the SCDM Code of
Ethics?
A. Studying for the exam with others
B. Writing practice questions and sharing them with others
C. Asking others to share items from the exam with you
D. Taking the exam more than once
top related