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 Obstacles in conducting clinical trials in the Saudi Arabia

2017 ◽  
Vol 4 (4) ◽  
pp. 166
Author(s):  
Salem D. Al Suwaidan ◽  
Aseel S. Alsuwaidan
Keyword(s):  
Clinical Trials ◽  
Saudi Arabia ◽  
Clinical Practice ◽  
Clinical Research ◽  
Strategic Plan ◽  
Good Clinical Practice ◽  
European Countries ◽  
Regulatory Authorities ◽  
Research Institution

<p class="abstract"><strong>Background:</strong> Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern.  It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.</p><p class="abstract"><strong>Methods:</strong> Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.</p><p><strong>Conclusions:</strong> To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.</p>

Becoming Licensed Means That I Am Now Competent

2019 ◽  
pp. 7-11
Author(s):  
Jeffrey E. Barnett ◽  
Jeffrey Zimmerman
Keyword(s):  
Mental Health ◽  
Clinical Practice ◽  
Clinical Competence ◽  
Education And Training ◽  
Hard Work ◽  
Mental Health Clinicians ◽  
Clinical Experiences ◽  
Graduate Coursework ◽  
And Training ◽  
Over Time

Mental health clinicians invest in many years of hard work to develop their clinical competence through graduate coursework and through supervised clinical experiences. All this is done with the ultimate goal of becoming independently licensed to practice in one’s profession. Because licensure is such an important event, signifying the culmination of so much education and training, it may be natural to believe that becoming licensed means that one is now clinically competent. This chapter addresses how clinical competence and licensure should be viewed and understood. Licensure assesses one’s competence to enter the profession, but it cannot guarantee competence in all areas of clinical practice at the time of licensure or in the future. How to maintain, update, and expand one’s competence over time is addressed. Risks and threats to competence are discussed, and recommendations are provided for ensuring one’s ongoing competence over time.

Why do patients attend and what do they want from the consultation?

2020 ◽  
pp. 14-19
Author(s):  
Des Spence
Keyword(s):  
Clinical Practice ◽  
Healthcare System ◽  
Healthcare Professionals ◽  
Medical Profession ◽  
Education And Training ◽  
Health Seeking Behaviour ◽  
Health Seeking ◽  
Do No Harm ◽  
Developed World ◽  
And Training

Contrary to traditional thinking and teaching, it is not illness that dictates the health-seeking behaviour of a population but the healthcare system itself, and—most importantly—our actions as healthcare professionals. A scourge affecting clinical practice in the developed world today is the medicalization of all interactions, accompanied by overinvestigation, overdiagnosis, and overtreatment. The medical profession retains its traditional duty, wherever possible, to diagnose disease and treat or cure illness appropriately, also to comfort the sick, irrespective of the ability to cure. At the same time, a long-held principle of medicine at all levels is to do no harm, while at the same time supporting the maintenance of health and protecting those who are well. This chapter explains how maintaining the balance between these apparent conflicting precepts is a scarce skill that needs to be taught by example during the education and training of the modern doctor.

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 European survey on national training activities in clinical research

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
A. Magnin ◽  
V. Cabral Iversen ◽  
G. Calvo ◽  
B. Čečetková ◽  
O. Dale ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Core Competencies ◽  
Good Clinical Practice ◽  
Specific Training ◽  
Continuous Training ◽  
Number Of Patients ◽  
Starting Point ◽  
Training Activities ◽  
Career Options

Abstract Background Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists. Methods To fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action. Results The survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries. Conclusions There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.

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