Clinical research is conducted to advance human medicine by developing efficacious treatments and improving patient outcomes when new therapies are developed and implemented. Clinical trials are a subset of the types of clinical research conducted on human volunteers in the development of new drugs, devices and other therapies. Prior to the start of a trial, a country’s regulatory authority must review the trial to ensure it is scientifically and ethically sound. In Canada, the regulatory authority is Health Canada. The International Conference on Harmonization (ICH) of technical requirements for the registration of pharmaceutics for humans aims to provide ethical and scientific quality standards for design, conduct, data collection and reporting in clinical trials. The Good Clinical Practice (GCP) Guidelines were created by the ICH Steering Committee to assure the public that rights, safety and well being of subjects are protected according to the Declaration of Helsinki, and the clinical data obtained in a ICH/GCP compliant clinical trial will meet regulatory requirements. Health Canada has adopted the ICH/GCP Guidelines and therefore, in Canada, all clinical trials involving humans must comply with these Guidelines. The clinical trial coordinator is an important and central position on the research team executing many trial duties and communications. Regulatory authorities, Research Ethics Boards and the sponsor, overlook the role and responsibilities of a highly trained clinical coordinator, despite their vital and central position. The GCP Guidelines also fail to address the role and responsibilities of a clinical coordinator. Disconnect between guidelines, regulatory expectations and actual trial conduct provides an apparent need to formalize and clearly define the role and scope of a clinical coordinator. The Registered Nurse (RN) brings professionalism, knowledge, skill and a holistic perspective to the expanded role of a clinical coordinator and to the clinical trial. Highly trained health professionals are capable of assuming more responsibilities and executing clinical trial design, setup and management as compared to the traditional administrative roles of the clinical coordinator. The expanded role of the clinical coordinator is especially beneficial for Principal Investigator initiated trials due to limited research personnel and resources. Postoperative adhesions are a common complication following pelvic surgery, therefore, this clinical trial is relevant and a response to a healthcare need. My graduate studies focused on the development and set up of the clinical trial Protocol ADE002-2013 Phase I Trial of L-Alanyl-L-Glutamine for the Reduction of Peritoneal Adhesions in Adult Females Undergoing Myomectomy. My thesis is a discussion of general Canadian clinical trial research information followed by an explanation of how we executed the information to design and set up our PI initiated clinical trial. The value of the expanded role of the clinical coordinator as a member of the research team will also be discussed.

The global trend towards an ageing population presents challenges for health-care professionals, including registered nurses (RNs). In Taiwan, health care policies relating to the aged and to gerontological nursing are still in the early stages of development. Integral to this development is the evolving definition of the clinical role of RNs who make a major contribution to aged care. Using data from in-depth interviews of 29 RNs working across eight nursing homes, this grounded theory study examines the factors that shape the care work of RNs in long-term aged care in Taiwan. The objectives of this study were to: * examine the work-experience perceptions of RNs employed in nursing homes in Taiwan * explore the factors that influence the delivery of nursing care to the aged by RNs * explain the events that constitute nursing practices in aged care provision that have an effect on the roles of RNs, and * develop a theoretical proposition that can guide future nursing practice in aged care. Grounded theory and symbolic interactionism are the complementary methodologies selected to underpin this study. The perspective of grounded theory allows for a critical investigation of the social processes that are integral in shaping the perspectives of RNs who work in Taiwanese nursing homes. The application of the theory of symbolic interactionism facilitates an exploration of the roles of RNs in this context and of the different meanings for individuals in the various situations they confront. Organizational factors and interactions that shape the role of RNs in the working environment of aged care are highlighted in the interaction between the data and the theory. The core category that emerged from the study was searching for an identity. This core process reflects ambivalence in the perceptions of RNs in describing and explaining the nursing role in Taiwanese nursing homes. Five categories that bring some greater understanding of this ambivalence are: coming to know, doing anything and everything, negotiating the work role, dealing with the system, and learning by being there. The specific intention of this study was to extend our understanding of nursing work and the delivery of care to older people in nursing homes in Taiwan. The findings of this study will contribute to the development of an educational framework that may be applied to improve nursing practices in nursing homes. These findings also have the potential to make a positive contribution to aged health care policy-making in Taiwan.

Thesis (Ph. D.)--School of Education. University of Missouri--Kansas City, 2006. / "A dissertation in urban leadership and policy studies in education and education." Advisor: Carolyn J. Thompson. Typescript. Vita. Title from "catalog record" of the print edition Description based on contents viewed Oct. 31, 2007. Includes bibliographical references (leaves 210-219). Online version of the print edition.

Thesis (Ed. D.)--Indiana University of Pennsylvania. / Includes bibliographical references.

Thesis (M.S.)--Ball State University, 2008. / Title from PDF t.p. (viewed on Aug. 21, 2009). Research paper (M.S.), 3 hrs. Includes bibliographical references (p. 58-61).

Thesis (M.A.)--Northern Kentucky University, 2007. / Made available through ProQuest. Publication number: AAT 1441006. ProQuest document ID: 1283974311. Includes bibliographical references (p. 85-88)

Thesis (M.A.)--Northern Kentucky University, 2006. / Made available through ProQuest. Publication number: AAT 1437573. ProQuest document ID: 1203575511. Includes bibliographical references (p. 44-46)

Thesis (Ed. D.)--West Virginia University, 2009. / Title from document title page. Document formatted into pages; contains ix, 143 p. : ill. Vita. Includes abstract. Includes bibliographical references (p. 112-123).

Bakgrund Stress och liknande känslotillstånd hos nyutexaminerade sjuksköterskor är ett vanligt problem. Syfte Undersöka hur nyutexaminerade sjuksköterskor upplevde tiden före sin första anställning och under första året i yrkeslivet. Fokus lades på känslor av oförbereddhet och stress och huruvida det påverkade omvårdnaden, samt hur detta hade kunnat avhjälpas. Metodbeskrivning Sju semi-strukturerade kvalitativa intervjuer genomfördes. Insamlat material analyserades genom en modifierad version av kvalitativ innehållsanalys. Resultat Övergången från sjuksköterskestudent till yrkesverksam sjuksköterska kunde innebära psykiska och fysiska påfrestningar och leda till symptom på utmattningssyndrom. Faktorer för att undvika skadlig stress var att det sociala arbetet ansågs givande, god inskolning och handledning, samt stöd genom yrkesförlagd utbildning på arbetsplatsen. Positiv feedback under verksamhetsförlagd utbildning (VFU) ökade tron egenförmågan. Faktorer som påverkade övergången negativt var press från kollegor, brist på kunskap och rutin, höga förväntningar på sig själv och för lite undervisning i farmakologi, medicinsktekniska moment och medicinsk teori. Basal- och specialiserad omvårdnad, läkemedel- och medicintekniska moment blev lidande på grund av stress. Slutsats Första året inom sjuksköterskeyrket innebär ett stort ansvar med påföljande stress och liknande tillstånd. En trygg sjuksköterska riskerar mindre av dessa problem vilket leder till förbättrad omvårdnad och patientsäkerhet. För att få en trygg inskolning och kompensera för bristande erfarenhet i yrkesrollen krävs från arbetsgivarens sida en individanpassad handledning med mentor, god arbetsmiljö och handledning efter introduktionsperiodens slut och reflektionsgrupper. Utbildningen förser studenterna med trygghet genom VFU och omvårdnadsteori samtidigt som en större bredd inom medicin och farmakologi efterfrågas. En tuff inledande period kan delvis kompenseras av det sociala arbetet / Background Stress and similar feelings are common problems among newly graduated nursing students which can be caused by lack of skill while adjusting to work. Purpose The purpose of this study was to examine how newly graduated nurses experienced the time before their first employment as well the first year into the profession, focusing on whether feeling unprepared and/or stressed had any effect on patient-related care, and in that case unfold how this could have been prevented in any fashion. Method Seven semi-structured qualitative interviews with registered nurses were conducted. Data was analyzed through a modified version of qualitative content analysis. Results The transition phase from being a nursing student to becoming a certified nurse could cause both mental and physical stress, which in turn might lead to experiencing symptoms of fatigue. Factors that had a positive effect on coping were: a sense of fulfillment from social work, a positive acclimatization and tutoring, and receiving support throughout the entire trainee period. Positive feedback during this trainee period increased self-efficacy. Factors that had a negative effect on coping were; pressure from colleagues, a lack of competence and routine, high self-expectations and a lack of education regarding pharmacology, basic and specialized nursing, medicine and health technology. Conclusion The first year in the nursing profession includes great responsibility, stress and stress related conditions. The feeling of being confident in work related situations reduces the risk of developing stress related issues, and leads to improved care and patient safety. To compensate for the lack of experience in the professional role, the employers need to offer a good working environment with access to a mentor and participation in reflection groups during and after the introductory period. The nursing education provides a sufficient part of internship and nursing theory, but more training and theory in medicine and pharmacology is requested. Stress and related conditions during the first year in the nursing profession is partly compensated by feelings of joy perceived in the social work.

Bakgrund: Medellivslängden i Sverige ökar och äldre personer använder allt fler läkemedel. Med stigande ålder sker kroppsliga förändringar vilket ökar risken för läkemedelsbiverkningar/-interaktioner. Dessa läkemedelsrelaterade problem kan minska livskvaliteten för äldre personer men sjuksköterskor/distriktssköterskor kan med rätt kunskaper och genom att arbeta tvärprofessionellt bidra till att minska problemen. Syfte: Syftet var att studera hur sjuksköterskor och distriktssköterskor inom hemsjukvård uppfattar kunskaper om läkemedel samt det tvärprofessionella arbetet kring läkemedel. Metod: Studien hade en kvantitativ design och genomfördes som en enkätstudie riktad till sjuksköterskor/distriktssköterskor inom hemsjukvård. Data bearbetades med statistikprogrammet SPSS 22. För korrelationer användes Mann-Whitneys U-test, Wilcoxon´s rangsummetest och Spearman´s rangkorrelation. Resultat: Deltagarna ansåg att läkemedelskunskaper var viktiga men att det var svårt att identifiera läkemedelsrelaterade problem. Distriktssköterskorna kände sig säkrare på läkemedelsrelaterade frågor efter sin utbildning. Deltagarna ansåg att det fanns otillräckligt med tid avsatt med läkare och omvårdnadspersonal för att diskutera läkemedelsrelaterade frågor. De kände sig trygga med att omvårdnadspersonal tog kontakt vid läkemedelsrelaterade problem men upplevde att det var svårt att få tag på läkare tillräckligt snabbt. Konklusion: För att minska läkemedelsrelaterade problem inom hemsjukvården finns behov av ökade läkemedelskunskaper hos sjuksköterskor/distriktssköterskor samt ökat samarbete med läkare och omvårdnadspersonal. / Background: Average life span in Sweden is increasing and elderly use more and more medication. With age, alterations in body constitution take place, leading to an increased risk of adverse drug reactions. These drug related problems can decrease quality of life for elderly people but with right knowledge and by working multidisciplinary nurses/district nurses can decrease them. Aim: The aim was to study how nurses and district nurses within home nursing view drug knowledge and multidisciplinary work on drugs. Metod: A quantitative design was used and the study was conducted as a questionnaire survey, adressed to nurses/district nurses within home nursing. Data was analysed using the statistics software of SPSS 22. Mann-Whitneys U-test, Wilcoxon´s sign-rank test and Spearman´s rho were used to find statistical correlations. Results: The participants considered drug knowledge to be important but found it hard to identify drug related problems. The district nurses felt more secure in drug related issues after graduation. The participants considered that the amount of time scheduled with physicians and nursing assistants to discuss drug-related matters were insufficient. They felt confident in that nursing assistants would contact them in event of adverse drug reactions but stated it was hard to reach physicians quickly enough. Conclusion: To decrease drug related problems within home nursing there is need for increased drug knowledge amongst nurses/district nurses as well as an increased cooperation with physicians and nursing assistants.