scholarly journals Commentary: Compliance Education and Training: A Need for New Responses in Clinical Research

2010 ◽  
Vol 85 (3) ◽  
pp. 395-397 ◽  
Author(s):  
Mindy J. Steinberg ◽  
Elaine R. Rubin
Keyword(s):  
Clinical Research ◽  
Education And Training ◽  
And Training

scholarly journals 2069

2017 ◽  
Vol 1 (S1) ◽  
pp. 43-44
Author(s):  
Carlton Hornung ◽  
Carolyn Thomas Jones ◽  
Terri Hinkley ◽  
Vicki Ellingrod ◽  
Nancy Calvin-Naylor
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Core Competencies ◽  
Safety Data ◽  
The United States ◽  
Education And Training ◽  
Development Ethics ◽  
The Impact ◽  
And Training ◽  
Research Professionals

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

scholarly journals All nurses need to be research nurses

2017 ◽  
Vol 1 (5) ◽  
pp. 269-270 ◽  
Author(s):  
Patricia Eckardt ◽  
Marilyn J. Hammer ◽  
Margaret Barton-Burke ◽  
Margaret McCabe ◽  
Christine T. Kovner ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Quality Care ◽  
Good Clinical Practice ◽  
Education And Training ◽  
Validity And Reliability ◽  
Test Items ◽  
Research Nurses ◽  
Training Need ◽  
And Training

IntroductionNurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.MethodsA collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.ResultsA pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.ConclusionsAs the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.

scholarly journals Education and training for medicines development, regulation, and clinical research in emerging countries

2015 ◽  
Vol 6 ◽  
Author(s):  
Sandor Kerpel-Fronius ◽  
Bernd Rosenkranz ◽  
Elizabeth Allen ◽  
Rolf Bass ◽  
Jacques D. Mainard ◽  
...  
Keyword(s):  
Clinical Research ◽  
Education And Training ◽  
Emerging Countries ◽  
Development Regulation ◽  
And Training

scholarly journals A Foreword from the Editor

2016 ◽  
Vol 1 (2) ◽  
pp. 1
Author(s):  
Jean-Marie Boeynaems
Keyword(s):  
Clinical Research ◽  
Education And Training ◽  
Current Trends ◽  
Scien Tists ◽  
Adequate Education ◽  
And Training

We are glad to publish the second issue of the Journal of Medicines Development Sciences. It illustrates three current trends in medicines development:• The rising role of small biotech companies,• The initiatives launched in many countries to boost clinical research,• The importance of an adequate education and training of physicians and scien-tists involved in medicines development.

scholarly journals Certification of clinical and translational researchers: An ill-conceived notion

2017 ◽  
Vol 1 (1) ◽  
pp. 3-4
Author(s):  
Paul R. Marantz ◽  
Harry P. Selker ◽  
Emma A. Meagher
Keyword(s):  
Clinical Research ◽  
Multiple Choice ◽  
Education And Training ◽  
Certification Process ◽  
National Board ◽  
Research Education ◽  
Medical Examiners ◽  
And Training

AbstractThe National Board of Medical Examiners (NBME) has instituted a new multiple choice examination in order to “certify” clinical and translational investigators. As experienced research educators, we argue that this certification process is unnecessary, values knowledge over competency, may be counter-productive, and is unlikely to achieve any worthwhile outcome. We lay out these arguments in the hope of stimulating a robust discussion among leaders, faculty, and learners engaged in clinical research education and training.

scholarly journals Call us nurse champions: Lessons learned in strategic partnership with nurses in clinical research

2020 ◽  
Vol 8 (4) ◽  
pp. 13
Author(s):  
Rebecca Koszalinski ◽  
Theresa Day ◽  
Clay Kyle
Keyword(s):  
Clinical Research ◽  
Nurse Managers ◽  
Research Study ◽  
Medical Center ◽  
Education And Training ◽  
Lessons Learned ◽  
Strategic Partnership ◽  
Regional Medical ◽  
Regional Medical Center ◽  
And Training

This manuscript reports the perspectives of nurse managers who participated in a study at a regional medical center. The information is reported through verbatim comments that emerged through a discussion of “lessons learned”. Nursing comments are organized as the conversation flowed. The nurse managers that participated in a recently concluded study were most concerned about how any research study will affect their patients and how nurse workflow may be interrupted. Pre-established meeting times (huddles) worked best for education and training. Further, they suggested incentives may be effective; however, recognition as nurse champions and inclusion of nurse voice are preferred.

scholarly journals Competency indices to assess the knowledge, skills and abilities of clinical research professionals

2018 ◽  
Vol 5 (1) ◽  
pp. 46 ◽  
Author(s):  
Carlton A. Hornung ◽  
Carolynn Thomas Jones ◽  
Nancy A. Calvin-Naylor ◽  
Jared Kerr ◽  
Stephen A. Sonstein ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Task Force ◽  
Core Competencies ◽  
Safety Data ◽  
Education And Training ◽  
Regulatory Affairs ◽  
The Impact ◽  
And Training ◽  
Research Professionals

<p class="abstract"><strong>Background:</strong> Clinical research in the 21<sup>st</sup> century will require a well-trained workforce to ensure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel and others.</p><p class="abstract"><strong>Methods:</strong> We used data collected by the joint task force on the harmonization of core competencies from a survey of research professionals working in the US and Canada to create competency Indices for clinical research professionals. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies.</p><p class="abstract"><strong>Results:</strong> Factor analyzes identified 20 core competencies that defined a competency index for clinical research professionals—general (CICRP-General, i.e., GCPs) and four sub-indices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts.  </p><p><strong>Conclusions:</strong> These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors and other clinical research team members.</p>

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