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 founded 1994 GCDMP vs 1.0 2000 SCDM Code of Ethics 2003 Certification exam vs 1 Beta test 2004 1 st 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

5. Discipline Maturity Model Learn by trial & error OR skill training Learn by apprenticeship, OJT, Best Practice Learn by formal degree programs, OJT 2 o 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 tradeProfessionDiscipline

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 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.

8. ADULT LEARNING PRINCIPLES In four slides …

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 Content Connection Application

13. APPLICABLE TO CDM Available degree programs

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. Biomedical Informatics Bioinformatics Computational biology ImagingClinical Informatics Public Health Informatics Molecular Cellular Tissue Organ Human 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

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

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

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

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 Learn Educate & Train the Next generation Thank you !!