Formal Education and Degree
Programs Relevant to Clinical
Data Management
Meredith Nahm, PhD, CCDM
Duke 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
1st SCDM fall
conference,
Philadelphia
SCDM Code
of Ethics
2003
Webinar
1997
1994
2009
2005
GCDMP vs 1.0
SCDM
founded
First SCDM OnFirst SCDM line course
2000
First SCDM
Certification exam
Certification exam vs 1 Beta test
training, Colorado
2003
2004
Definition of the
profession
initiated
2012
Discipline Maturity Model
Skilled trade
Learn by trial
& error OR
skill training
Work activity
is an “art”
No
standardization
Quality depends
mainly on individual
skill
Low
Profession
Discipline
Learn by
apprenticeship, OJT,
Best Practice
Learn by
formal degree
programs, OJT 2o
Activities coalesce,
form practice
supported by body of
knowledge
Profession
supported by a
scientific discipline
Pseudostandardization
through best practice
Quality depends mainly
on individual skill
High
Standardization
Quality depends on
capable processes
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.
Training
• gain a skill
Assessment:
• Demonstration of fact
memorization
• Association between concepts.
• Application of knowledge to
solve problems.
• Application of knowledge in
new domains to solve
problems.
Assessment:
• Skill demonstration
• Check for knowledge
• Sometimes no verification that
the learner had achieved the
desired skills.
In four slides …
ADULT LEARNING
PRINCIPLES
• 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.
lt Learning,” by Malcolm S. Knowles, The ASTD Training & Development
dbook: A Guide to Human Resource Development, Robert L. Craig, editor, 1996
Knowles Adult Learning
Assumptions
Educators have determined that most adults, adolescents, and children learn best by
experiencing a blend of activities that promote the three learning domains:
cognitive, affective, and behavioral. Cognitive refers to knowledge or a body of
subject matter, affective refers to attitudes and beliefs, and behavior refers to
practical application.
Three Learning Domains
The table below shows examples of activities in each of the three domains.
COGNITIVE
AFFECTIVE
BEHAVIORAL
Lectures
Values clarification exercises
Role plays
Brainstorms
Nominal group process
Simulations
Discussions
Consensus-seeking activities
Teach backs
Source: Principles of Adult Learning & Instructional Systems Design
https://www.nhi.fhwa.dot.gov/downloads/freebies/172/PR%20Pre-
ng
We retain approximately 10 percent of what we see; 30 to 40 percent of what
we see and hear; and 90 percent of what we see, hear, and do. We all have the
capability to learn via all three styles, but are usually dominate in one.
Three Learning Styles
VISUAL
AUDITORY
KINESTHETIC
Transparencies
Lectures
Role plays
Videos/Slides
Group discussions
Simulations
Flip charts
Informal conversations
Practice demonstrations
Readings
Stories and examples
Writing/Note taking
Demonstrations
Brainstorms
Activities
2
Source: Principles of Adult Learning & Instructional Systems Design
https://www.nhi.fhwa.dot.gov/downloads/freebies/172/PR%20Pre-
The table below shows some of the methods that appeal to visual, auditory, and
kinesthetic learners. Training should take into account all three styles.
Adult Learning
Connection
Content
Application
Available degree programs
APPLICABLE TO CDM
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
Bioinformatics Imaging Clinical
Computational biology
Informatics
Molecular
Cellular
Tissue
Organ
Human
Public
Health
Informatics
Human
Population
s
Diagram taken from: Shortliffe, Edward H., Cimino, James J., Biomedical Informatics: Computer
Applications in Health Care and Biomedicine (Health Informatics) third ed. Springer 2006
Public
Health
Informatics
Clinical
Informatics
Bioinformatics
Imaging
Computational biology
Biomedical Informatics
Public Health
Medical Record
Surveillance,
Outcomes
CRF data
Images
Clinical Research
Informatics: Broad
area,
drawing from the
“-omics” data
multiple areas of
Biomedical Informatics
CDM
Study
design
Site
Selection
Start-up
IRB
approval
Patient
Recruit
-ment
Data
Analysis
collection
&
&
reporting
processing
FDA
review
Clinical Data Management
Post
market
Surveil
-lance
CRI & CDM
Clinical Research Informatics
Non-trials clinical research
Study
design
Site
Selection
Start-up
Study
design
Site
Selection
Start-up
IRB
approval
Patient
Recruit
-ment
Data
Analysis
collection
&
&
reporting
processing
IRB
approval
Patient
Recruit
-ment
Data
Analysis
collection
&
&
reporting
processing
Translation
review
Into
practice
FDA
review
Clinical Trials
Clinical Data Management
Post
market
Surveil
-lance
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 Learn
Educate & Train the Next generation
Thank you !!