Formal Education and Degree Programs Relevant to Clinical Data Management

Meredith Nahm, PhD, CCDMDuke Translational Medicine Institute

After this session, you should be able to:• Identify theoretical foundations relevant to the

learning of clinical data management skills.  • Compare and contrast education, training and

professional development programs.• Identify and describe model programs currently in

operation in both industry and academe.• Identify competences in informatics programs and

their graduates relevant to clinical data management.

This Talk Will Cover

• Differences between education, training, and professional development

• Key adult learning principles• Activities underway to identify Clinical Research

Informatics competencies for degree programs • Available degree/certificate programs

SCDM Profession Milestones

SCDM founded

1994

GCDMP vs 1.0

2000

SCDM Code of Ethics

2003

Certification exam vs 1 Beta test

2004

1st SCDM fall conference, Philadelphia

1997

First SCDM Webinar

2005

First SCDM Certification exam training, Colorado

2003

First SCDM On-line course

2009

Definition of the profession

initiated

2012

Discipline Maturity Model

Learn by trial & error OR skill training

Learn by apprenticeship,

OJT, Best Practice

Learn by formal degree

programs, OJT 2o

Work activity is an “art”

Quality depends mainly on individual

skill

Activities coalesce, form practice

supported by body of knowledge

Quality depends mainly on individual skill

Profession supported by a

scientific discipline

Quality depends on capable processes

No standardization

Pseudo-standardization

through best practice

Standardization

Low

High

Skilled trade Profession Discipline

Degree Program Need

• CDM degree programs lacking – Increases training burden on employers– Decreases qualified job candidates

• CDM is getting more complicated• Employers of CDMs

60 Clinical and Translational Science Award institutions

Therapeutic development industry

Federal Government: NIH, FDA, VA

Research will not end anytime soon …

Education versus Training

Education• gain knowledge about facts,

events, principles, concepts, theories, laws of nature.

Assessment:• Demonstration of fact

memorization• Association between concepts. • Application of knowledge to

solve problems.• Application of knowledge in

new domains to solve problems.

Training• gain a skill

Assessment:• Skill demonstration• Check for knowledge • Sometimes no verification that

the learner had achieved the desired skills.

ADULT LEARNING PRINCIPLES

In four slides …

Knowles Adult Learning Assumptions• Adults want to know why they should

learn.

• Adults need to take responsibility.

• Adults bring experience to learning.

• Adults are ready to learn when the need arises.

• Adults are task-oriented.

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Content

Connection

Application

APPLICABLE TO CDMAvailable degree programs

Informatics?

The science of information.

Health Informatics: use of information to improve human health

Clinical Research Informatics: use of information - in research in humans - to facilitate translation of new discoveries into improvements in human health

Biomedical Informatics

BioinformaticsComputational biology

Imaging ClinicalInformatics

Public Health

Informatics

MolecularCellular

TissueOrgan

Human Human Populations

Diagram taken from: Shortliffe, Edward H., Cimino, James J., Biomedical Informatics: Computer Applications in Health Care and Biomedicine (Health Informatics) third ed. Springer 2006

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Public Health Surveillance,Outcomes

Medical Record CRF data

Images

“-omics” data

Clinical Research Informatics: Broad

area,drawing from the multiple areas of

Biomedical Informatics

CDM

SiteSelectionStart-up

IRB approval

PatientRecruit-ment

Data collection

& processing

Analysis&

reporting

FDAreview

Post marketSurveil-lance

Studydesign

Clinical Data Management

CRI & CDM

SiteSelectionStart-up

IRB approval

PatientRecruit-ment

Data collection

& processing

Analysis&

reporting

FDAreview

Post marketSurveil-lance

Studydesign

Clinical Research Informatics

Clinical Data Management

TranslationInto

practice

Non-trials clinical research

SiteSelectionStart-up

IRB approval

PatientRecruit-ment

Data collection

& processing

Analysis&

reporting review

Studydesign

Clinical Trials

Clinical Research Informatics Text

CRI Specific Programs

• Work underway to create CRI competencies• Will inform CRI specific curriculum and

program development• Status: SCDM Cert. Competencies, along

with others have been mapped to AMIA competencies

• Developed programs should prepare great CDM candidates

Available Programs

• AMIA CRI 10x10 course (on-line)

• Stanford: Clinical Research Informatics Graduate Certificate

• Ohio State: Clinical and Translational Research Informatics Training Program (CTRIP), post-doctoral Master of Science

Note: different intended audiences 1) Clinical Investigators, 2) Clinical users of informatics, 3) Health informaticists awareness of CRI, 4) Future informaticists (Cert & MS), 5) Informatics researchers

Go Forth, Teach and LearnEducate & Train the Next generation

Thank you !!