INDEX 1.Introduction to Clinical Trials 3 2.Clinical Trial Protocol 5 3.International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 6 1.1.Introduction to GCP 6 1.2.Sections of GCP Guidelines 6 3.2.1.1Section 1- Glossary of various terms 6 3.2.1.2Section 2- Principles of ICH-GCP 7 3.2.1.3Section 3- Institutional Review Board/Independent Ethics Committee(IRB/IEC) 8 3.2.1.4Responsibilities 8 3.2.1.5Composition‚ Functions and Operations
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Clinical Guidelines Introduction This assignment is focused on a schizophrenia clinical guideline. According to NICE (2009) Clinical guidelines are “recommendations on the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales”. Clinical guidelines are based on the best available evidence. Guidelines help healthcare professionals in their work‚ but they do not replace their knowledge and skills. The chosen guideline is called core interventions
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Ethical Guidelines for Observational Studies Observational Research‚ Audits and Related Activities December 2006 Ethical Guidelines for Observational Studies: Observational Research‚ Audits and Related Activities Citation: National Ethics Advisory Committee. 2006. Ethical Guidelines for Observational Studies: Observational research‚ audits and related activities. Wellington: Ministry of Health. Published in December 2006 by the Ministry of Health PO Box 5013‚ Wellington‚ New Zealand
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OBJECTIVE: To recommend effective strategies for implementing clinical practice guidelines (CPGs). DATA SOURCES: The Research and Development Resource Base in Continuing Medical Education‚ maintained by the University of Toronto‚ was searched‚ as was MEDLINE from January 1990 to June 1996‚ inclusive‚ with the use of the MeSH heading "practice guidelines" and relevant text words. STUDY SELECTION: Studies of CPG implementation strategies and reviews of such studies were selected. Randomized controlled
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CLINICAL AUDIT LITERATURE AND EVIDENCES [ARTICLE] Audit is currently defined as a cyclical activity incorporating both systematic evaluation of the quality of clinical practice and action .The aim of audit is to establish the extent to which actual clinical practice compares with best clinical practice. Bowie etal(2012 It incorporates the systematic and critical analysis by nurses‚ midwives and health visitors‚ in conjunction with other staff‚ of the planning‚ delivery and evaluation
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Clinical supervision sits at the heart of the UK Government ’s agenda for improving the quality of service delivery (Department of Health‚ 1997‚ 1998‚ 1999). The practice in the workplace was introduced as a way of using reflective practice and shared experiences as a part of continuing professional development. Clinical supervision has ensured that standards of clinical care remain a key mechanism for monitoring the performance of Trusts‚ with clinical performance measures being given equal weight
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Clinical Trials ‘All patients should receive the best possible therapy AND the well-being of the individual research subject must take precedence over all other interests.’ Says article 11.3 of the ‘Declaration of Helsinki’‚ the Holy Grail for biomedical research on humans. With more and more clinical trials being conducted in developing countries‚ the question naturally arises…while outsourcing these trials‚ are the pharmaceutical companies growing to disregard this declaration? To be able
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Explain what is meant by the term ‘clinical governance’ AND discuss the implications and impact of clinical governance on practicing pharmacists and pharmacy services. Throughout the world‚ societies are striving to determine how best to organise their health systems and deliver services. Increasingly‚ there is recognition that the development and evaluation of new therapies and diagnostic tools is only part of the answer to better health care(1). Clinical governance first began to appear in the
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Clinical Psychology Gabriela Alvarez Clinical Psychology Clinical psychology is one of the most prominent specialty areas in psychology today. Clinical psychology focuses and strives to understand‚ assess and treat psychological and behavioral problems and disorders (Plante‚ 2010). According to Bedi (2012)‚ “Clinical psychology is a broad approach to human problems . . . with regard to numerous populations.” Furthermore‚ analyzing the methods in which the human psyche interacts with
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Examine Clinical Psychology The History of Clinical Psychology Clinical Psychology is the part of the psychology field that focuses on treatment and evaluation of mental illness‚ psychiatric issues and abnormal behaviors. The treatment that developed in clinical psychology assists persons with their development as an individual and well-being (The History‚ 2013). Clinical psychology started at the University of Pennsylvania in 1896 when a clinic was
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