Formal Education and Degree Programs Relevant to Clinical Data Management

1. Formal Education and Degree Programs Relevant to Clinical Data Management Meredith Nahm, PhD, CCDM Duke Translational Medicine Institute

2. 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.

3. 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

4. SCDM Profession Milestones SCDM Code of Ethics 2003 1st SCDM fall conference, Philadelphia 1997 First SCDM On-line course 2009 First SCDM Webinar 2005 GCDMP vs 1.0 2000 First SCDM Certification exam training, Colorado 2003 Certification exam vs 1 Beta test 2004 Definition of the profession initiated 2012 SCDM founded 1994

5. Discipline Maturity Model Skilled trade Profession Discipline Learn by apprenticeship, OJT, Best Practice Learn by formal degree programs, OJT 2o Learn by trial & error OR skill training High Activities coalesce, form practice supported by body of knowledge Work activity is an “art” Profession supported by a scientific discipline Pseudo-standardization through best practice No standardization Standardization Quality depends mainly on individual skill Quality depends on capable processes Quality depends mainly on individual skill Low

6. 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 …

7. 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. Education versus Training

8. In four slides … Adult Learning Principles

9. 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. “Adult Learning,” by Malcolm S. Knowles, The ASTD Training & Development Handbook: A Guide to Human Resource Development, Robert L. Craig, editor, 1996

10. Three Learning Domains Source: Principles of Adult Learning & Instructional Systems Design https://www.nhi.fhwa.dot.gov/downloads/freebies/172/PR%20Pre-course%20Reading%20Assignment.pdf

11. Three Learning Styles Source: Principles of Adult Learning & Instructional Systems Design https://www.nhi.fhwa.dot.gov/downloads/freebies/172/PR%20Pre-course%20Reading%20Assignment.pdf

12. Adult Learning Connection Application Content

13. Available degree programs Applicable to CDM

14. 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

15. Molecular Cellular Tissue Organ Human Human Populations Biomedical Informatics Bioinformatics Computational biology Imaging Clinical Informatics Public Health Informatics Diagram taken from: Shortliffe, Edward H., Cimino, James J., Biomedical Informatics: Computer Applications in Health Care and Biomedicine (Health Informatics) third ed. Springer 2006

16. Biomedical Informatics Surveillance, Outcomes Public Health Medical Record CRF data Public Health Informatics Bioinformatics Computational biology Imaging Clinical Informatics Images “-omics” data Clinical Research Informatics: Broad area, drawing from the multiple areas of Biomedical Informatics

17. CDM Study design Site Selection Start-up IRB approval Patient Recruit -ment Data collection & processing Analysis & reporting FDA review Post market Surveil -lance Clinical Data Management

18. Non-trials clinical research Study design Site Selection Start-up IRB approval Patient Recruit -ment Data collection & processing Analysis & reporting review Translation Into practice CRI & CDM Clinical Research Informatics Study design Site Selection Start-up IRB approval Patient Recruit -ment Data collection & processing Analysis & reporting FDA review Post market Surveil -lance Clinical Trials Clinical Data Management

19. Clinical Research Informatics Text

20. 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

21. 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

22. Go Forth, Teach and LearnEducate & Train the Next generation Thank you !!