...Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision? 1. Ethical aspect. Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines: • Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials. • Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the...
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...Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision? 1. Ethical aspect. Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines: • Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials. • Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the benefits it brings...
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...UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2009 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from to Commission File No. 0-28882 WORLD HEART CORPORATION Delaware (State or other Jurisdiction of Incorporation or Organization) 4750 Wiley Post Way, Suite 120 Salt Lake City, Utah USA (Address of Principal Executive Office) (801) 355-6255 (Registrant’s Telephone Number) Securities registered pursuant to Section 12(b) of the Exchange Act: Title of each class Name of each exchange on which registered 52-2247240 (I.R.S. Employer Identification No.) 84116 (Zip Code) Common Stock, $0.001 par value NASDAQ Capital Market Securities registered pursuant to Section 12(g) of the Exchange Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements...
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...required of me and my investigators? ▪ The OHSRP website: https://federation.nih.gov/ohsr/nih/investigator-training.php, divides training by type of research conducted. Training curricula are specified as Clinical Research, Epidemiological and Social Behavioral Research, and Basic Science Research. ▪ Each type has a link associated with it that when accessed, instructions are given, required courses and Just-in-Time/optional courses are listed, and the training links to each course are provided. ▪ Just-in-Time CITI courses may be required by the IRB or PI if an investigator is conducting research involving certain specialized areas, but are otherwise optional (e.g. GCP courses are optional, for research staff who do not conduct FDA-regulated research.) IRBs or PIs may also require Key Research Personnel to complete these courses. . How do I choose between the CRT, CITI Biomedical and the NIH CC Ethics course? ▪ CITI courses offer a “test-out” option. If you achieve a score of 80%, you will not be required to take the full course. ▪ CITI also offers the option to take the full course with CMEs (fee required). ▪ The NIH CRT can be accessed without an NIH login. ▪ The Ethical and Regulatory Aspects of Clinical Research course is an in-person course offered annually by the CC Bioethics Department. It can be taken as the primary training course, as well as a refresher course in place of the CRT or the CITI Biomedical course...
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...required of me and my investigators? ▪ The OHSRP website: https://federation.nih.gov/ohsr/nih/investigator-training.php, divides training by type of research conducted. Training curricula are specified as Clinical Research, Epidemiological and Social Behavioral Research, and Basic Science Research. ▪ Each type has a link associated with it that when accessed, instructions are given, required courses and Just-in-Time/optional courses are listed, and the training links to each course are provided. ▪ Just-in-Time CITI courses may be required by the IRB or PI if an investigator is conducting research involving certain specialized areas, but are otherwise optional (e.g. GCP courses are optional, for research staff who do not conduct FDA-regulated research.) IRBs or PIs may also require Key Research Personnel to complete these courses. . How do I choose between the CRT, CITI Biomedical and the NIH CC Ethics course? ▪ CITI courses offer a “test-out” option. If you achieve a score of 80%, you will not be required to take the full course. ▪ CITI also offers the option to take the full course with CMEs (fee required). ▪ The NIH CRT can be accessed without an NIH login. ▪ The Ethical and Regulatory Aspects of Clinical Research course is an in-person course offered annually by the CC Bioethics Department. It can be taken as the primary training course, as well as a refresher course in place of the CRT or the CITI Biomedical course...
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...7/1/2011 Contents Introduction 2 What is clinical research? 2 The state of health in India 2 Clinical Research Market in India 3 Factors that Continue to Make India Attractive for Future Clinical Trial Outsourcing: 4 Challenges for the Indian Clinical Research Industry 6 Cinical research profession 7 Conclusion 8 Introduction Successful persons in business are noted to be blessed with innovation, perseverance and a broad vision. Its critical to have the “big picture” in mind while we want to position and well-establish the smallest things, after all the intensity of effect that something can cause cannot be under-estimated. A tiny sim-card that provides enormous data and communication coverage, an atom bomb which caused ruthless destruction in Japan, a small silicon chip that provides powerful processing speed in our computers, a tablet of aspirin that at times saves life; none can be ignored. It is important, thus, to identify the patterns, the trends, the relationships between smaller items in the “big picture” to channelize our efforts towards a unique direction. Behind every innovation lies a unique idea, and behind every successful idea lies the large audience it will cater to. Clinical research is one such area that can help a large population with some of their grave needs through small yet life-changing discoveries. What is clinical research? As per wikipedia.com, “Clinical research is a branch of medical science that determines the...
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...Key Personnel Group 3: IRB Member module. This course consists of 4 subparts on IRB membership for current IRB members. This course should not be attempted until a Basic Human Subjects Course is completed. Choose this learner group and follow the link to the Basic Course. Good Clinical Practice and ICH: This course consists of 13 modules on GCP and ICH E6 for invetigators. This Basic GCP course should not be attempted until the Basic Human Subjects Course is completed. Choose this learner group and follow the link to the Basic Course. Lab Animal Welfare: Select this response to bypass the Human Subjects Course Go to Question 3 for the Lab Animal Course and select the appropriate response. 2. CITI HUMAN SUBJECTS (REFRESHER) Select the group for which you have previously completed an institutionally approved Basic Course in the Protection of Human Research Subjects. https://www.citiprogram.org/dev/enroll/selectgroups.asp?strKeyID=3FE2B565-AC6F-40C... 2/28/2008 Select Curriculum Page 2 of 3 Choose one answer Group 1.: Biomedical Research Investigators and Key Personnel. Group 2.: Social / Behavioral Research Investigators and Key Personnel Good Clinical Practice and ICH: This course consists of 13 modules on GCP and ICH E6 for invetigators. This Basic GCP course should not be attempted until the...
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...ADVANCED WORKSHOP : REVIEW OF DRUG DEVELOPMENT IN CLINICAL TRIALS BANGKOK, 2-6 FEB 2009 Opening and Welcome Speech Mrs Werawan Tangkeo The Deputy Secretary General of Thai Food and Drug Administration @ The Siam City Hotel, Bangkok 2-6 February 2009 Dr Viner, Dr Stevens, Dr Sato, and Dr Sudhichai, Distinguished participants, Ladies and Gentlemen: It gives me a great pleasure to welcome all of you and chair the Opening Ceremony this morning to the “Advanced Workshop: Review of Drug Development in Clinical Trials” jointly organized by Asia Pacific Economic Co-operation and Food and Drug Administration, Thailand. The significance of Drug Clinical Trials and Capacity Building for Drug Regulatory Agencies are well noticed by several international networks including ASEAN or Association of South East Asian Nations, APEC or Asia Pacific Economic Cooperation, and ICH Global Cooperation Group. This project has been endorsed by ASEAN Working Group on Technical Cooperation in Pharmaceutical (AWGTCP), APEC Life Sciences Innovation Forum (LSIF) and ICH Global Cooperation Group (GCG) since the year 2002, 2006 and 2007, respectively. By the listed international cooperation, indeed, we have received technical, financial, and moral supports. Please allow me to recall the last year achievement of hosting 2 training workshops in Thailand, those are “Preliminary Workshop : Review of Drug Development in Clinical Trials” and “Basic Workshop on GCP/ Clinical Research Inspection”. The accomplishments of...
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...Section One – Clinical Learning Environment This section provides a critical discussion of the clinical environment within which I’m presently working. I will aim to identify and discuss further ways in which our learning environment is conducive to a positive learning experience for students, as well as identifying areas in which the environment could be enhanced. This critical analysis will look in particular at those areas of the clinical environment which have been identified in research as being both positively and negatively influential on a students’ learning experience. According to Nicklin and Kenworthy (2000) the clinical learning environment, within the content of nursing, can be defined as: “Those circumstances that directly or otherwise influence the teaching and learning of nursing.” (Nicklin and Kenworthy, 2000, p13) This is more recently supported by O’Mara et al (2014) who highlight that clinical nursing education is of vital importance in providing students with opportunities to integrate their theoretical knowledge into their nursing care, develop clinical judgement and a professional identity. Furthermore, they identify that the clinical nursing environment has many complex variables which could influence students’ learning experiences, both positively and negatively. Walsh (2014) discusses several such variables which should be considered in the clinical learning environment. These are categorised into the following main areas; staff, availability of...
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...and explore the experience of mentoring a student in practice, critically analysing topics that will reflect on the role of the mentor, within the context of the nursing profession. The placement area concerned is a 14 bedded acute elderly assessment ward, which caters for both male and female patients. Several students have been placed on our ward over the years, it is the mentors responsibility to provide students with appropriate support, guidance and supervision within the clinical environment, Myall 2008. One of the key issues that need to be considered in preparation for an effective learning environment would be making sure the student is aware of the situations that could arise on the ward, discussing typical events that could happen on a daily basis. clinical experience can be a stressful part of the nursing program, working in a unfamiliar area, working with difficult patients and the fear of making mistakes. Hutchinson (2003) believes that a teacher should aim to provide an environment in which learners feel safe to experiment, voice their concerns, identify their lack of knowledge and stretch their limits. One of the major factors affecting learning is the environment in which it takes place. It is the responsibility of professional staff to create and develop an environment conductive to learning (Price, 2004). This implies that the environment should be continually monitored to ensure it provides...
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...The aim of this assignment is to demonstrate that I can through critical reflection, evaluate my performance as a mentor to a student nurse I have been working with on the ward. According to the Nursing and Midwifery Council (NMC) (2006) the term mentor is used to denote the role of a registered nurse who facilitates learning and supervises and assesses students in the practice place. They furthermore identify the eight mandatory standards that must be achieved to become a mentor, and within the assignment I shall be referring to the Standards to Support Learning and Assessment in Practice; NMC standards for mentors, practice teachers and teachers, and identifying the standards for mentors required (SM). This assignment will first look at the personal and professional reasons why I wanted to undertake the mentorship module. It will also discuss the importance of a supportive learning environment in the workplace, and how essential it is. My role as a mentor to a nursing student will be evaluated, looking at the way in which I supported her on the ward and how I facilitated this. In conclusion, I will identify my own personal development in undertaking and completing this module. As a registered nurse on a busy Paediatric ward I always enjoy supporting student nurses whilst they are on placement with us. There is an apparent shortage of qualified mentors on the ward, and within my last personal development review with my line manager I identified a need to attain the mentorship...
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...a variety of professions (Gopee, 2011) as too have the requirements for mentors within the health profession. The current definition from the Nursing and Midwifery Council (NMC, 2008a) states that “A mentor is a registrant who has met the outcomes (of a mentor preparation course) and who facilitates learning, supervises and assesses students in a practice setting” (NMC, 2008a). The role of a clinical nurse mentor is described as someone who supervises, teaches and assesses student nurses in a practice setting (Jokelainen et al, 2011, Ousey, 2009), although the role is more complex in that a clinical nurse mentor needs to process the ability to select and support learning opportunities, they have a responsibility to manage diversity and equality, be accountable and ensure standards are maintained (NMC, 2008a). This is supported by Jokelainen et al (2011) who describes mentoring as being complex due to contextual, collegial, pedagogical and clinical teaching. Student nurses are supernumerary in the practice placement, meaning they are there as learners even though they must make an active contribution to the work of the practice area (RCN, 2007). Their active contribution is additionally supported by Morgan (2002) who emphasises that students may feel surplus to requirements through their supernumerary status. Standards relating to mentoring nursing students are set by the Nursing and Midwifery Council (2008a). They include; establishing effective working relationship through...
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...and explore the experience of mentoring a student in practice, critically analysing topics that will reflect on the role of the mentor, within the context of the nursing profession. The placement area concerned is a 14 bedded acute elderly assessment ward, which caters for both male and female patients. Several students have been placed on our ward over the years, it is the mentors responsibility to provide students with appropriate support, guidance and supervision within the clinical environment, Myall 2008. One of the key issues that need to be considered in preparation for an effective learning environment would be making sure the student is aware of the situations that could arise on the ward, discussing typical events that could happen on a daily basis. clinical experience can be a stressful part of the nursing program, working in a unfamiliar area, working with difficult patients and the fear of making mistakes. Hutchinson (2003) believes that a teacher should aim to provide an environment in which learners feel safe to experiment, voice their concerns, identify their lack of knowledge and stretch their limits. One of the major factors affecting learning is the environment in which it takes place. It is the responsibility of professional staff to create and develop an environment conductive to learning (Price, 2004). This implies that the environment should be continually monitored to ensure it provides...
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...THE PROBLEM AND ITS SETTING Background of the Study Learning in clinical environment involves what Jarvis (2006) defines as action learning, which involves “learning by doing... within a specified social context” (in nursing it is the clinical area). It also involves much more complex learning such as learning of concepts, problem solving, decision making, rule learning, critical thinking. The nursing educators and institutions have an ethical obligation to ensure admission criteria and academic standards that are reasonable and fare, yet effective indicators of students’ success. When an educational institution issues a diploma to one of its students, it is, in effect certifying the society that the student possesses all the knowledge and skills that are required in his chosen discipline. To remain competitive and accountable, it is imperative for nursing programmes to have efficient and reliable admission criteria. Quantitative data and research- base facts are essential for the development, revision and modification of the admission criteria to guide nursing educators to identify and select those students who will successfully complete the nursing programme. It also helps in minimizing the wastage of human and material resources that occur due to student failure and attrition (Dr. Romana Idrees, 2008). Furthermore, the students are exposed to a wide variety of clinical settings—including hospitals, outpatient, community clinics, treatment centers...
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...Nurse Education in Practice (2008) 8, 103–111 Nurse Education in Practice www.elsevierhealth.com/journals/nepr Belongingness: A prerequisite for nursing students’ clinical learning Tracy Levett-Jones a a,* , Judith Lathlean b,1 School of Nursing and Midwifery, The University of Newcastle, Callaghan, NSW 2308, Australia School of Nursing and Midwifery, The University of Southampton, Nightingale Building (67), University Road, Highfield, Southampton SO17 1BJ, United Kingdom b Accepted 4 April 2007 KEYWORDS Belongingness; Nursing student; Learning; Clinical placement Introduction Summary The concept of belongingness has intuitive appeal. Human beings are social creatures; the need to belong and be accepted is fundamental, and social exclusion can be devastating. This paper reports on the selected findings from the qualitative phase of mixed-methods study that explored nursing students’ experience of belongingness while on clinical placements. The 18 interview participants in this study were from Australia and the United Kingdom. They provided a range of perspectives on belongingness and how it influenced their placement experience. Central to this discussion was their strong belief that belonging is a prerequisite for clinical learning. This theme dominated all of the interviews. Given that the primary purpose of clinical placements is for students to learn to nurse, there needs to be a clear understanding of the relationship between belongingness...
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