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Leaning Forward! Emerging Collaborations, Research & Accreditation

Leaning Forward! Emerging Collaborations, Research & Accreditation. COAPCR Annual Meeting DIA Convention June 26, 2013 Boston, MA. www.coapcr.org. Carolynn Thomas Jones, RN, MSPH President, Consortium of Academic Programs in Clinical Research ( CoAPCR )

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Leaning Forward! Emerging Collaborations, Research & Accreditation

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  1. Leaning Forward! Emerging Collaborations, Research & Accreditation COAPCR Annual Meeting DIA Convention June 26, 2013 Boston, MA www.coapcr.org Carolynn Thomas Jones, RN, MSPH President, Consortium of Academic Programs in Clinical Research (CoAPCR) Faculty, School of Nursing, University of Alabama at Birmingham

  2. Brief Overview: Define CoAPCR Define: What is clinical research? Present career paths and stakeholders Defining core competencies for APCR www.coapcr.org

  3. Provides a medium for communication among CRP educators Encourages the development of academically based CRP educational programs. Fosters inter-institutional articulation Initiates research, study and discussion relating to the educational, manpower and service needs of CRPs. Offers a mechanism for program accreditation www.coapcr.org

  4. Clinical Research - It’s global. Number of Clinical Trials- March 2013

  5. What is clinical research and who works in that “world”? 10,000 250 5 1 FDA Approved Compounds Drug TIME: 15 Years COST: $1.6 Billion

  6. POTENTIAL STUDENTS Year 0 15

  7. STAKEHOLDERS Employers of Clinical Research Professionals

  8. Salary Scales- Clinical Research Careers

  9. Competency-Based Education for Clinical Research Professionals From the Literature • Shamoo AE, Resnik DB. 2006. Ethical issues for clinical research managers. DIA J.;40:371-383. • Carter, S. C., Jester, P. M., & Thomas Jones, C. (2007). Issues in clinical research manager education and training. Research Practitioner, 8(2):48-60 • Jones CT, Harrison L, Carter S. Education and training preferences of clinical research managers. 2008. Research Practitioner ; 9(6):201-211. • Ekmekci O, Bocchino J, Turley C, Butler J. 2011 Who is a Clinical Research Professional? Monitor; 25(5):11-20. • Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and Training Needs of Pharmaceutical Physicians in the United States. Monitor; 25(6):9-15. • Jones, C.T., Parmentier, J., Sonstein, S., Silva, H., Lubejko, B., Pidd, H., Gladson, B., Browning, S. (2012). Defining competencies in clinical research: Issues in clinical research education. Research Practitioner, 13(3), 99-107.

  10. Educational Modalities Used by Clinical Research Professionals On the job training continues to be a primary mode, until something happens! & New Regulatory Requirements

  11. Modified from Table 1 of Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and Training Needs of Pharmaceutical Physicians in the United States. Monitor 25(6):9-15.

  12. Modified from Table 2 of Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and Training Needs of Pharmaceutical Physicians in the United States. Monitor 25(6):9-15.

  13. How can we narrow the learning gaps for clinical research professionals? What is the impact of learning gaps on healthcare costs and public safety ? Education vs training. Importance of critical thinking!

  14. CoAPCR Competency Development Process APPI ACRP NIH-NCRR-CTSA program NIH Clinical Center – Clinical Research Nursing2010 Oncology Nursing Society Royal College of Nursing (UK) Quality and Safety Education for Nurses (QSEN) IACRN Scopes and Standards CoAPCR In Tandem! Jones, C.T., Parmentier, J., Sonstein, S., Silva, H., Lubejko, B., Pidd, H., Gladson, B., Browning, S. (2012). Defining competencies in clinical research: Issues in clinical research education. Research Practitioner, 13(3), 99-107.

  15. Scientific Concepts and Principles of Research Design Medical Product Development Clinical Study Operation and Regulatory Compliance Ethical Considerations and the Responsible Conduct of Clinical Research Clinical Study and Site Management Data Management and Informatics Communication of Scientific Data Professionalism, Teamwork and Leadership CoAPCR Core Competency Domains Committee on Accreditation (CoA) Chair, Stephen Sonstein Program Curriculum & Courses

  16. CoAPCR Mission The Consortium of Academic Programs in Clinical Research facilitates the development of high-quality educational programs encompassing all areas of clinical research that are based in academic credit-granting institutions. • Collaboration • Research • Accreditation

  17. www.coapcr.org cjthomas@uab.edu

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