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.

Certification Exam BlueprintHow the exam is designed, structured and maintained

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

Types of Studies CDMs Support

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.

Preparing for the Exam

Read the Certification

Handbook

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

Competencies

are In the

Certification

Handbook.

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.

Exam Logistics

Beta Exam Cost: $100.00 members

• 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 !

Practice QuestionsJust for fun

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

Real Questions ??What didn’t we cover that you want to know?